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Evaluation of Efficacy of 20 µg/ml rhNGF New Formulation (With Anti-oxidant) in Patients With Stage 2 and 3 NK

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02227147
Recruitment Status : Completed
First Posted : August 27, 2014
Results First Posted : June 14, 2019
Last Update Posted : June 14, 2019
Sponsor:
Information provided by (Responsible Party):
Dompé Farmaceutici S.p.A

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Neurotrophic Keratitis
Interventions Drug: rhNGF 20µg/ml
Other: Placebo
Enrollment 48
Recruitment Details

Recruitment was competitive among the study sites, until the planned number of patients were randomized.

Competitive recruitment was chosen to increase the speed of recruitment and to account for any difference in enrolment rate among study sites.

Pre-assignment Details  
Arm/Group Title rhNGF 20 µg/ml Vehicle
Hide Arm/Group Description

rhNGF 20 µg/ml eye drops solution, formulation containing anti-oxidant

rhNGF 20µg/ml

vehicle, formulation containing anti-oxidant

Placebo Vehicle

Period Title: Controlled Treatment Period
Started 24 24
Completed 18 21
Not Completed 6 3
Reason Not Completed
Adverse Event             4             3
not specified             2             0
Period Title: Follow-up Period
Started 18 21
Completed 15 16
Not Completed 3 5
Reason Not Completed
Not specified             3             5
Arm/Group Title rhNGF 20 µg/ml Vehicle Total
Hide Arm/Group Description

rhNGF 20 µg/ml eye drops solution, formulation containing anti-oxidant

rhNGF 20µg/ml

vehicle, formulation containing anti-oxidant

Placebo Vehicle

Total of all reporting groups
Overall Number of Baseline Participants 24 24 48
Hide Baseline Analysis Population Description
ITT population
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 24 participants 24 participants 48 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
11
  45.8%
13
  54.2%
24
  50.0%
>=65 years
13
  54.2%
11
  45.8%
24
  50.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 24 participants 24 participants 48 participants
65.9  (13.85) 54.5  (14.15) 65.2  (13.87)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 24 participants 24 participants 48 participants
Female
14
  58.3%
15
  62.5%
29
  60.4%
Male
10
  41.7%
9
  37.5%
19
  39.6%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 24 participants 24 participants 48 participants
24
 100.0%
24
 100.0%
48
 100.0%
1.Primary Outcome
Title Complete Healing of the Persistent Epithelial Defect (PED) or Corneal Ulcer Defined by Central Reviewer
Hide Description Percentage of patients achieving complete healing of the PED or corneal ulcer determined by corneal fluorescein staining at 8 weeks as defined by the central reading center on clinical pictures.
Time Frame Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population, LOCF. One patient (randomized to rhNGF although not eligible) had no post-baseline data, was assumed to be missing, and was excluded from the analyses.
Arm/Group Title rhNGF 20 µg/ml Vehicle
Hide Arm/Group Description:

rhNGF 20 µg/ml eye drops solution, formulation containing anti-oxidant

rhNGF 20µg/ml

vehicle, formulation containing anti-oxidant

Placebo Vehicle

Overall Number of Participants Analyzed 23 24
Measure Type: Number
Unit of Measure: percentage of participants
Completely healed 70 29
Not completely healed 30 71
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection rhNGF 20 µg/ml, Vehicle
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value =0.006
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value 40.4
Confidence Interval (2-Sided) 90.00%
14.2 to 66.6
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Complete Healing of the Persistent Epithelial Defect (PED) or Corneal Ulcer Defined by the Investigator
Hide Description Percentage of patients experiencing complete healing of the PED or corneal ulcer determined by corneal fluorescein staining at 8 weeks as measured by the investigator.
Time Frame Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population, LOCF. One patient (randomized to rhNGF although not eligible) had no post-baseline data, was assumed to be missing, and was excluded from the analyses.
Arm/Group Title rhNGF 20 µg/ml Vehicle
Hide Arm/Group Description:

rhNGF 20 µg/ml eye drops solution, formulation containing anti-oxidant

rhNGF 20µg/ml

vehicle, formulation containing anti-oxidant

Placebo Vehicle

Overall Number of Participants Analyzed 23 24
Measure Type: Number
Unit of Measure: percentage of participants
Completely healed 65 29
Not completely healed 35 71
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection rhNGF 20 µg/ml, Vehicle
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value =0.013
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value 36.1
Confidence Interval (2-Sided) 95.0%
9.4 to 62.7
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Complete Healing of the Persistent Epithelial Defect (PED) or Corneal Ulcer Defined by Central Reading Center and Investigator.
Hide Description Percentage of patients experiencing complete healing of the PED or corneal ulcer at 4, and 6 weeks as measured by the central reading center evaluating the clinical pictures and investigator.
Time Frame At weeks 4 and 6
Hide Outcome Measure Data
Hide Analysis Population Description
LOCF, ITT population. One patient (randomized to rhNGF although not eligible) had no post-baseline data, was assumed to be missing, and was excluded from the analyses.
Arm/Group Title rhNGF 20 µg/ml Placebo
Hide Arm/Group Description:

rhNGF 20 µg/ml eye drops solution, formulation containing anti-oxidant

rhNGF 20µg/ml

Vehicle: formulation containing anti-oxidant

Placebo: Formulation containing antioxidant

Overall Number of Participants Analyzed 23 24
Measure Type: Number
Unit of Measure: percentage of participants
Week 4 - central reviewer - yes 56 38
Week 4 - central reviewer - no 44 62
Week 6 - central reviewer - yes 56 46
Week 6 - central reviewer - no 44 54
Week 4 - investigator - yes 56 42
Week 4 - investigator - no 44 58
Week 6 - investigator - yes 65 42
Week 6 - investigator - no 35 58
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection rhNGF 20 µg/ml, Placebo
Comments week 4 - central reviewer
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value =0.191
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter difference in percentage
Estimated Value 19.0
Confidence Interval (2-Sided) 95%
-9.0 to 47.1
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection rhNGF 20 µg/ml, Placebo
Comments week 6 - central reviewer
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value =0.464
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter difference in percentage
Estimated Value 10.7
Confidence Interval (2-Sided) 95%
-17.7 to 39.1
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection rhNGF 20 µg/ml, Placebo
Comments week 4 - investigator
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value =0.308
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter difference in percentage
Estimated Value 14.9
Confidence Interval (2-Sided) 95%
-13.4 to 43.1
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection rhNGF 20 µg/ml, Placebo
Comments week 6 - investigator
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value =0.106
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter difference in percentage
Estimated Value 23.6
Confidence Interval (2-Sided) 95%
-4.2 to 51.3
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Percentage of Patients With Complete Corneal Clearing
Hide Description Percentage of patients with complete corneal clearing at weeks 4, 6, and 8 defined as grade 0 on the modified Oxford scale. Grade 0 indicates the absence of conjunctival staining; grade V indicates severe conjunctival staining.
Time Frame at weeks 4, 6, and 8
Hide Outcome Measure Data
Hide Analysis Population Description
LOCF, ITT population. Two patients (randomized to rhNGF although not eligible) had no post-baseline data, were assumed to be missing, and were excluded from the analyses.
Arm/Group Title rhNGF 20 µg/ml Placebo
Hide Arm/Group Description:

rhNGF 20 µg/ml eye drops solution, formulation containing anti-oxidant

rhNGF 20µg/ml

Vehicle: formulation containing anti-oxidant

Placebo: Formulation containing antioxidant

Overall Number of Participants Analyzed 22 24
Measure Type: Number
Unit of Measure: percentage of participants
Week 4 - yes 14 4
Week 4 - no 86 96
Week 6 - yes 9 8
Week 6 - no 91 92
Week 8 - yes 23 4
Week 8 - no 77 96
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection rhNGF 20 µg/ml, Placebo
Comments week 4
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value =0.255
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter difference in percentage
Estimated Value 9.5
Confidence Interval (2-Sided) 95%
-6.9 to 25.9
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection rhNGF 20 µg/ml, Placebo
Comments week 6
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value =0.927
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter difference in percentage
Estimated Value 0.8
Confidence Interval (2-Sided) 95%
-15.6 to 17.1
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection rhNGF 20 µg/ml, Placebo
Comments week 8
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value =0.062
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter difference in percentage
Estimated Value 18.6
Confidence Interval (2-Sided) 95%
-0.7 to 37.8
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Mean Change From Baseline in Best Corrected Distance Visual Acuity (BCDVA)
Hide Description

Change in Best Corrected Distance Visual Acuity (BCDVA) from baseline to Week 8.

Best Corrected Distance Visual Acuity consists of letters read at 4m only.

Time Frame Baseline, Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
LOCF, ITT Population
Arm/Group Title rhNGF 20 µg/ml Placebo
Hide Arm/Group Description:

rhNGF 20 µg/ml eye drops solution, formulation containing anti-oxidant

rhNGF 20µg/ml

Vehicle: formulation containing anti-oxidant

Placebo: Formulation containing antioxidant

Overall Number of Participants Analyzed 23 24
Mean (Standard Deviation)
Unit of Measure: letters read correctly
4.48  (9.25) 4.33  (10.399)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection rhNGF 20 µg/ml, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value =0.745
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter difference in least square means
Estimated Value 1.1
Confidence Interval (2-Sided) 95%
-5.6 to 7.7
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Percentage of Patients That Achieve a 15 Letter Gain in BCDVA
Hide Description Percentage of patients that achieve a 15 letter gain in Best Corrected Distance Visual Acuity (BCDVA) at 4 weeks, 6 weeks, 8 weeks
Time Frame Weeks 4, week 6 and week 8
Hide Outcome Measure Data
Hide Analysis Population Description
LOCF, ITT population
Arm/Group Title rhNGF 20 µg/ml Placebo
Hide Arm/Group Description:

rhNGF 20 µg/ml eye drops solution, formulation containing anti-oxidant

rhNGF 20µg/ml

Vehicle: formulation containing anti-oxidant

Placebo: Formulation containing antioxidant

Overall Number of Participants Analyzed 24 24
Measure Type: Number
Unit of Measure: percentage of subjects
week 4 - yes 9 12
week 4 - no 91 88
week 6 - yes 13 12
week 6 - no 87 88
week 8 -yes 13 17
week 8 - no 87 83
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection rhNGF 20 µg/ml, Placebo
Comments week 4
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value =0.672
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter difference in percentage
Estimated Value -3.8
Confidence Interval (2-Sided) 95%
-21.3 to 13.7
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection rhNGF 20 µg/ml, Placebo
Comments week 6
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value =0.955
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter difference in percentage
Estimated Value 0.5
Confidence Interval (2-Sided) 95%
-18.5 to 19.6
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection rhNGF 20 µg/ml, Placebo
Comments week 8
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value =0.727
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter difference in percentage
Estimated Value -3.6
Confidence Interval (2-Sided) 95%
-23.9 to 16.7
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Improvement in Corneal Sensitivity
Hide Description

Improvement in corneal sensitivity was measured by the Cochet-Bonnet aesthesiometer at 4, 6 and 8 weeks.

Corneal sensitivity is measured continuously in each patient in cm:

  • Area of the Persistent Epithelial Defect (PED) or corneal ulcer
  • All quadrants, but outside the PED or corneal ulcer area: Superior nasal, inferior nasal, superior temporal, inferior temporal.

Improvement is defined as an increase of at least 0.5 cm in the location of concern.

Time Frame At 4, 6 and 8 weeks after start of the treatment
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population
Arm/Group Title rhNGF 20 µg/ml Placebo
Hide Arm/Group Description:

rhNGF 20 µg/ml eye drops solution, formulation containing anti-oxidant

rhNGF 20µg/ml

Vehicle: formulation containing anti-oxidant

Placebo: Formulation containing antioxidant

Overall Number of Participants Analyzed 24 24
Mean (Standard Deviation)
Unit of Measure: cm
week 4 Number Analyzed 20 participants 17 participants
2.50  (1.821) 1.56  (1.983)
week 6 Number Analyzed 19 participants 16 participants
2.26  (2.009) 1.84  (2.150)
week 8 Number Analyzed 18 participants 15 participants
2.91  (2.144) 1.83  (1.952)
Change from baseline to week 8 Number Analyzed 18 participants 15 participants
1.88  (1.401) 1.00  (1.254)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection rhNGF 20 µg/ml, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value =0.207
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter least square mean difference
Estimated Value 0.6
Confidence Interval (2-Sided) 95%
-0.4 to 1.5
Estimation Comments [Not Specified]
8.Secondary Outcome
Title Patients Experiencing Deterioration
Hide Description Number of patients experiencing deterioration (increase in lesion size ≥ 1mm and/or decrease in BCDVA by >5 Early Treatment Diabetic Retinopathy Study (ETDRS) letters and/or progression in lesion depth to corneal melting or perforation and/or onset of infection) in stage 2 or 3 NK from baseline to Week 8.
Time Frame from baseline to Week 8.
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population. As far as this endpoint is concerned, data are available (non-missing) for 18 patients out of 24 in the rhNGF group, and for 15 patients out of 24 for the vehicle group.
Arm/Group Title rhNGF 20 µg/ml Placebo
Hide Arm/Group Description:

rhNGF 20 µg/ml eye drops solution, formulation containing anti-oxidant

rhNGF 20µg/ml

Vehicle: formulation containing anti-oxidant

Placebo: Formulation containing antioxidant

Overall Number of Participants Analyzed 18 15
Measure Type: Number
Unit of Measure: Number of subjects
Deterioration 0 2
No deterioration 18 13
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection rhNGF 20 µg/ml, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value =0.110
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter difference in percentage
Estimated Value -13.3
Confidence Interval (2-Sided) 95%
-30.5 to 3.9
Estimation Comments [Not Specified]
Time Frame Adverse events were analyzed by study period (Controlled Treatment Period, Follow-up Period and Uncontrolled Treatment Period).
Adverse Event Reporting Description

The number of Participants considered in the Adverse Event Section reflects the safety subset population of the study:

  • 23 patients: rhNGF during the Controlled Treatment Period
  • 24 patients: vehicle during the Controlled Treatment Period
  • 18 patients: rhNGF during the Follow-up Period
  • 21 patients: vehicle during the Follow-up Period
  • 13 patients: vehicle during the Controlled Treatment Period and rhNGF during the Uncontrolled Treatment Period
 
Arm/Group Title rhNGF 20 µg/ml - Controlled Treatment Period Vehicle - Controlled Treatment Period rhNGF 20 µg/ml - Follow-up Period Vehicle - Follow-up Period Uncontrolled Treatment Period
Hide Arm/Group Description

rhNGF 20 µg/ml eye drops solution, formulation containing anti-oxidant

rhNGF 20µg/ml

vehicle, formulation containing anti-oxidant

Placebo Vehicle

rhNGF 20 µg/ml eye drops solution, formulation containing anti-oxidant

rhNGF 20µg/ml

vehicle, formulation containing anti-oxidant

Placebo Vehicle

rhNGF 20 µg/ml eye drops solution, formulation containing anti-oxidant

Patients randomized to vehicle at baseline and not completely healed at week 8 who entered a 8-week treatment period before entering follow-up period

All-Cause Mortality
rhNGF 20 µg/ml - Controlled Treatment Period Vehicle - Controlled Treatment Period rhNGF 20 µg/ml - Follow-up Period Vehicle - Follow-up Period Uncontrolled Treatment Period
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/23 (0.00%)      0/24 (0.00%)      5/18 (27.78%)      2/21 (9.52%)      0/13 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
rhNGF 20 µg/ml - Controlled Treatment Period Vehicle - Controlled Treatment Period rhNGF 20 µg/ml - Follow-up Period Vehicle - Follow-up Period Uncontrolled Treatment Period
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   4/23 (17.39%)      4/24 (16.67%)      4/18 (22.22%)      2/21 (9.52%)      0/0    
Eye disorders           
Corneal Thinning  1  1/23 (4.35%)  1 0/24 (0.00%)  0 0/18 (0.00%)  0 0/21 (0.00%)  0 /0 
decreased visual acuity  1  0/23 (0.00%)  0 1/24 (4.17%)  2 1/18 (5.56%)  1 1/21 (4.76%)  2 /0 
Corneal perforation  1  0/23 (0.00%)  0 0/24 (0.00%)  0 2/18 (11.11%)  2 0/21 (0.00%)  0 /0 
Gastrointestinal disorders           
ventral hernia  1  0/23 (0.00%)  0 1/24 (4.17%)  1 0/18 (0.00%)  0 0/21 (0.00%)  0 /0 
General disorders           
Disease Progression  1  1/23 (4.35%)  1 2/24 (8.33%)  2 0/18 (0.00%)  0 0/21 (0.00%)  0 /0 
Death  1  0/23 (0.00%)  0 0/24 (0.00%)  0 1/18 (5.56%)  1 0/21 (0.00%)  0 /0 
Disease recurrence  1  0/23 (0.00%)  0 0/24 (0.00%)  0 0/18 (0.00%)  0 1/21 (4.76%)  1 /0 
Infections and infestations           
Viral gastroenteritis  1  0/23 (0.00%)  0 0/24 (0.00%)  0 1/18 (5.56%)  1 0/21 (0.00%)  0 /0 
Injury, poisoning and procedural complications           
Aqueous Humour Leakage  1  1/23 (4.35%)  1 0/24 (0.00%)  0 0/18 (0.00%)  0 0/21 (0.00%)  0 /0 
Nervous system disorders           
Syncope  1  1/23 (4.35%)  1 0/24 (0.00%)  0 0/18 (0.00%)  0 0/21 (0.00%)  0 /0 
1
Term from vocabulary, MedDRA 19.0
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 4%
rhNGF 20 µg/ml - Controlled Treatment Period Vehicle - Controlled Treatment Period rhNGF 20 µg/ml - Follow-up Period Vehicle - Follow-up Period Uncontrolled Treatment Period
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   21/23 (91.30%)      18/24 (75.00%)      14/14 (100.00%)      9/9 (100.00%)      7/13 (53.85%)    
Ear and labyrinth disorders           
Deafness bilateral  1  0/23 (0.00%)  0 0/24 (0.00%)  0 0/14 (0.00%)  0 1/9 (11.11%)  1 0/13 (0.00%)  0
motion sickness  1  0/23 (0.00%)  0 0/24 (0.00%)  0 0/14 (0.00%)  0 1/9 (11.11%)  1 0/13 (0.00%)  0
Eye disorders           
Visual acuity reduced  1  5/23 (21.74%)  5 5/24 (20.83%)  7 1/14 (7.14%)  1 2/9 (22.22%)  2 2/13 (15.38%)  2
Eye pain  1  7/23 (30.43%)  11 2/24 (8.33%)  2 3/14 (21.43%)  3 2/9 (22.22%)  2 2/13 (15.38%)  2
Corneal Epithelium Defect  1  3/23 (13.04%)  3 2/24 (8.33%)  2 2/14 (14.29%)  2 1/9 (11.11%)  1 0/13 (0.00%)  0
Eye Inflammation  1  3/23 (13.04%)  3 2/24 (8.33%)  2 0/14 (0.00%)  0 0/9 (0.00%)  0 0/13 (0.00%)  0
Lacrimation Increased  1  4/23 (17.39%)  4 1/24 (4.17%)  1 2/14 (14.29%)  2 0/9 (0.00%)  0 0/13 (0.00%)  0
Ocular Hyperaemia  1  4/23 (17.39%)  4 1/24 (4.17%)  1 0/14 (0.00%)  0 2/9 (22.22%)  2 0/13 (0.00%)  0
Corneal Thinning  1  2/23 (8.70%)  2 2/24 (8.33%)  2 0/14 (0.00%)  0 0/9 (0.00%)  0 0/13 (0.00%)  0
Eye Irritation  1  0/23 (0.00%)  0 4/24 (16.67%)  5 1/14 (7.14%)  1 0/9 (0.00%)  0 0/13 (0.00%)  0
Ocular Discomfort  1  2/23 (8.70%)  2 2/24 (8.33%)  2 1/14 (7.14%)  1 0/9 (0.00%)  0 0/13 (0.00%)  0
Photophobia  1  2/23 (8.70%)  2 2/24 (8.33%)  2 0/14 (0.00%)  0 0/9 (0.00%)  0 0/13 (0.00%)  0
Cataract  1  3/23 (13.04%)  3 0/24 (0.00%)  0 0/14 (0.00%)  0 1/9 (11.11%)  1 0/13 (0.00%)  0
Foreign Body Sensation In Eyes  1  2/23 (8.70%)  2 0/24 (0.00%)  0 1/14 (7.14%)  1 0/9 (0.00%)  0 0/13 (0.00%)  0
Posterior Capsule Opacification  1  1/23 (4.35%)  1 1/24 (4.17%)  1 0/14 (0.00%)  0 0/9 (0.00%)  0 0/13 (0.00%)  0
Anterior Chamber Inflammation  1  1/23 (4.35%)  1 0/24 (0.00%)  0 0/14 (0.00%)  0 0/9 (0.00%)  0 1/13 (7.69%)  1
Conjunctivitis Allergic  1  1/23 (4.35%)  1 0/24 (0.00%)  0 0/14 (0.00%)  0 0/9 (0.00%)  0 0/13 (0.00%)  0
Corneal Deposits  1  1/23 (4.35%)  1 0/24 (0.00%)  0 0/14 (0.00%)  0 0/9 (0.00%)  0 0/13 (0.00%)  0
Corneal Neovascularisation  1  0/23 (0.00%)  0 1/24 (4.17%)  2 0/14 (0.00%)  0 0/9 (0.00%)  0 0/13 (0.00%)  0
Corneal Perforation  1  0/23 (0.00%)  0 1/24 (4.17%)  1 0/14 (0.00%)  0 0/9 (0.00%)  0 0/13 (0.00%)  0
Eye Discharge  1  1/23 (4.35%)  1 0/24 (0.00%)  0 1/14 (7.14%)  1 0/9 (0.00%)  0 0/13 (0.00%)  0
Eye Pruritus  1  0/23 (0.00%)  0 1/24 (4.17%)  1 0/14 (0.00%)  0 0/9 (0.00%)  0 1/13 (7.69%)  1
Eye Swelling  1  1/23 (4.35%)  1 0/24 (0.00%)  0 0/14 (0.00%)  0 0/9 (0.00%)  0 0/13 (0.00%)  0
Eyelid Oedema  1  1/23 (4.35%)  1 0/24 (0.00%)  0 1/14 (7.14%)  1 0/9 (0.00%)  0 0/13 (0.00%)  0
Eyelid Pain  1  1/23 (4.35%)  2 0/24 (0.00%)  0 0/14 (0.00%)  0 0/9 (0.00%)  0 1/13 (7.69%)  1
Hyphaema  1  1/23 (4.35%)  1 0/24 (0.00%)  0 0/14 (0.00%)  0 0/9 (0.00%)  0 0/13 (0.00%)  0
Iritis  1  0/23 (0.00%)  0 1/24 (4.17%)  1 0/14 (0.00%)  0 0/9 (0.00%)  0 0/13 (0.00%)  0
Keratitis  1  1/23 (4.35%)  1 0/24 (0.00%)  0 0/14 (0.00%)  0 0/9 (0.00%)  0 0/13 (0.00%)  0
Macular Fibrosis  1  0/23 (0.00%)  0 1/24 (4.17%)  1 0/14 (0.00%)  0 0/9 (0.00%)  0 0/13 (0.00%)  0
Meibomian Gland Dysfunction  1  0/23 (0.00%)  0 1/24 (4.17%)  1 0/14 (0.00%)  0 1/9 (11.11%)  1 0/13 (0.00%)  0
Punctate Keratitis  1  0/23 (0.00%)  0 1/24 (4.17%)  1 0/14 (0.00%)  0 0/9 (0.00%)  0 0/13 (0.00%)  0
Trichiasis  1  1/23 (4.35%)  1 0/24 (0.00%)  0 1/14 (7.14%)  1 0/9 (0.00%)  0 0/13 (0.00%)  0
Ulcerative Keratitis  1  0/23 (0.00%)  0 1/24 (4.17%)  1 1/14 (7.14%)  1 0/9 (0.00%)  0 0/13 (0.00%)  0
Vision Blurred  1  0/23 (0.00%)  0 1/24 (4.17%)  1 0/14 (0.00%)  0 0/9 (0.00%)  0 0/13 (0.00%)  0
Vitreous Floaters  1  1/23 (4.35%)  1 0/24 (0.00%)  0 0/14 (0.00%)  0 0/9 (0.00%)  0 0/13 (0.00%)  0
Blepharitis  1  0/23 (0.00%)  0 0/24 (0.00%)  0 1/14 (7.14%)  1 0/9 (0.00%)  0 0/13 (0.00%)  0
Chalazion  1  0/23 (0.00%)  0 0/24 (0.00%)  0 1/14 (7.14%)  1 0/9 (0.00%)  0 0/13 (0.00%)  0
Conjunctivochalasis  1  0/23 (0.00%)  0 0/24 (0.00%)  0 1/14 (7.14%)  1 0/9 (0.00%)  0 0/13 (0.00%)  0
Corneal opacity  1  0/23 (0.00%)  0 0/24 (0.00%)  0 1/14 (7.14%)  1 0/9 (0.00%)  0 0/13 (0.00%)  0
Dry eye  1  0/23 (0.00%)  0 0/24 (0.00%)  0 1/14 (7.14%)  1 0/9 (0.00%)  0 0/13 (0.00%)  0
Floppy eyelid syndrome  1  0/23 (0.00%)  0 0/24 (0.00%)  0 1/14 (7.14%)  1 0/9 (0.00%)  0 0/13 (0.00%)  0
Gastrointestinal disorders           
Abdominal Hernia  1  0/23 (0.00%)  0 1/24 (4.17%)  1 0/14 (0.00%)  0 0/9 (0.00%)  0 0/13 (0.00%)  0
Lip Swelling  1  0/23 (0.00%)  0 1/24 (4.17%)  1 0/14 (0.00%)  0 0/9 (0.00%)  0 0/13 (0.00%)  0
Nausea  1  1/23 (4.35%)  1 0/24 (0.00%)  0 0/14 (0.00%)  0 0/9 (0.00%)  0 0/13 (0.00%)  0
Noninfective gingivitis  1  0/23 (0.00%)  0 0/24 (0.00%)  0 1/14 (7.14%)  1 0/9 (0.00%)  0 0/13 (0.00%)  0
General disorders           
Disease Progression  1  2/23 (8.70%)  2 4/24 (16.67%)  4 0/14 (0.00%)  0 0/9 (0.00%)  0 0/13 (0.00%)  0
Sensation Of Foreign Body  1  2/23 (8.70%)  2 2/24 (8.33%)  2 0/14 (0.00%)  0 0/9 (0.00%)  0 1/13 (7.69%)  1
Chest Pain  1  0/23 (0.00%)  0 1/24 (4.17%)  1 0/14 (0.00%)  0 0/9 (0.00%)  0 0/13 (0.00%)  0
Disease progression  1  0/23 (0.00%)  0 0/24 (0.00%)  0 0/14 (0.00%)  0 1/9 (11.11%)  1 0/13 (0.00%)  0
Sensation of foreign body  1  0/23 (0.00%)  0 0/24 (0.00%)  0 1/14 (7.14%)  1 0/9 (0.00%)  0 0/13 (0.00%)  0
Infections and infestations           
Eye Infection Intraocular  1  1/23 (4.35%)  1 0/24 (0.00%)  0 0/14 (0.00%)  0 0/9 (0.00%)  0 0/13 (0.00%)  0
Hordeolum  1  0/23 (0.00%)  0 1/24 (4.17%)  1 0/14 (0.00%)  0 0/9 (0.00%)  0 0/13 (0.00%)  0
Ophthalmic Herpes Zoster  1  1/23 (4.35%)  1 0/24 (0.00%)  0 0/14 (0.00%)  0 0/9 (0.00%)  0 0/13 (0.00%)  0
Respiratory Tract Infection  1  0/23 (0.00%)  0 1/24 (4.17%)  1 0/14 (0.00%)  0 0/9 (0.00%)  0 0/13 (0.00%)  0
Urinary Tract Infection  1  1/23 (4.35%)  1 0/24 (0.00%)  0 0/14 (0.00%)  0 0/9 (0.00%)  0 0/13 (0.00%)  0
Vulvovaginal Mycotic Infection  1  1/23 (4.35%)  1 0/24 (0.00%)  0 0/14 (0.00%)  0 0/9 (0.00%)  0 0/13 (0.00%)  0
Bronchitis  1  0/23 (0.00%)  0 0/24 (0.00%)  0 0/14 (0.00%)  0 2/9 (22.22%)  2 0/13 (0.00%)  0
Conjunctivitis  1  0/23 (0.00%)  0 0/24 (0.00%)  0 1/14 (7.14%)  1 0/9 (0.00%)  0 0/13 (0.00%)  0
Mastoiditis  1  0/23 (0.00%)  0 0/24 (0.00%)  0 0/14 (0.00%)  0 1/9 (11.11%)  1 0/13 (0.00%)  0
Nasopharyngitis  1  0/23 (0.00%)  0 0/24 (0.00%)  0 1/14 (7.14%)  1 0/9 (0.00%)  0 1/13 (7.69%)  1
Ophthalmic herpes simplex  1  0/23 (0.00%)  0 0/24 (0.00%)  0 1/14 (7.14%)  1 0/9 (0.00%)  0 0/13 (0.00%)  0
Upper respiratory tract infection  1  0/23 (0.00%)  0 0/24 (0.00%)  0 1/14 (7.14%)  1 0/9 (0.00%)  0 0/13 (0.00%)  0
Injury, poisoning and procedural complications           
Animal Bite  1  1/23 (4.35%)  1 0/24 (0.00%)  0 0/14 (0.00%)  0 0/9 (0.00%)  0 0/13 (0.00%)  0
Aqueous Humour Leakage  1  1/23 (4.35%)  1 0/24 (0.00%)  0 0/14 (0.00%)  0 0/9 (0.00%)  0 0/13 (0.00%)  0
Foot Fracture  1  1/23 (4.35%)  1 0/24 (0.00%)  0 0/14 (0.00%)  0 0/9 (0.00%)  0 0/13 (0.00%)  0
Contusion  1  0/23 (0.00%)  0 0/24 (0.00%)  0 0/14 (0.00%)  0 1/9 (11.11%)  1 0/13 (0.00%)  0
Investigations           
Intraocular Pressure Increased  1  3/23 (13.04%)  4 2/24 (8.33%)  2 2/14 (14.29%)  2 0/9 (0.00%)  0 0/13 (0.00%)  0
Metabolism and nutrition disorders           
Hyperkalaemia  1  0/23 (0.00%)  0 0/24 (0.00%)  0 0/14 (0.00%)  0 1/9 (11.11%)  1 0/13 (0.00%)  0
Hypoglycaemia  1  0/23 (0.00%)  0 0/24 (0.00%)  0 0/14 (0.00%)  0 0/9 (0.00%)  0 1/13 (7.69%)  1
Musculoskeletal and connective tissue disorders           
Joint Swelling  1  1/23 (4.35%)  2 0/24 (0.00%)  0 0/14 (0.00%)  0 0/9 (0.00%)  0 0/13 (0.00%)  0
Osteoporosis  1  1/23 (4.35%)  1 0/24 (0.00%)  0 0/14 (0.00%)  0 0/9 (0.00%)  0 0/13 (0.00%)  0
Pain In Extremity  1  1/23 (4.35%)  1 0/24 (0.00%)  0 0/14 (0.00%)  0 0/9 (0.00%)  0 0/13 (0.00%)  0
Bursitis  1  0/23 (0.00%)  0 0/24 (0.00%)  0 1/14 (7.14%)  1 0/9 (0.00%)  0 0/13 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)           
Papilloma  1  0/23 (0.00%)  0 0/24 (0.00%)  0 1/14 (7.14%)  1 0/9 (0.00%)  0 0/13 (0.00%)  0
Nervous system disorders           
Headache  1  1/23 (4.35%)  1 2/24 (8.33%)  2 0/14 (0.00%)  0 0/9 (0.00%)  0 1/13 (7.69%)  1
Diabetic Neuropathy  1  1/23 (4.35%)  1 0/24 (0.00%)  0 0/14 (0.00%)  0 0/9 (0.00%)  0 0/13 (0.00%)  0
Dizziness  1  1/23 (4.35%)  1 0/24 (0.00%)  0 0/14 (0.00%)  0 0/9 (0.00%)  0 0/13 (0.00%)  0
Paraesthesia  1  1/23 (4.35%)  1 0/24 (0.00%)  0 0/14 (0.00%)  0 0/9 (0.00%)  0 0/13 (0.00%)  0
Syncope  1  1/23 (4.35%)  1 0/24 (0.00%)  0 0/14 (0.00%)  0 0/9 (0.00%)  0 0/13 (0.00%)  0
Migrane  1  0/23 (0.00%)  0 0/24 (0.00%)  0 1/14 (7.14%)  1 0/9 (0.00%)  0 0/13 (0.00%)  0
Renal and urinary disorders           
Renal Impairment  1  0/23 (0.00%)  0 1/24 (4.17%)  1 0/14 (0.00%)  0 0/9 (0.00%)  0 0/13 (0.00%)  0
Respiratory, thoracic and mediastinal disorders           
Cough  1  0/23 (0.00%)  0 1/24 (4.17%)  1 0/14 (0.00%)  0 0/9 (0.00%)  0 0/13 (0.00%)  0
Nasal septum deviation  1  0/23 (0.00%)  0 0/24 (0.00%)  0 0/14 (0.00%)  0 0/9 (0.00%)  0 1/13 (7.69%)  1
Skin and subcutaneous tissue disorders           
Blister  1  1/23 (4.35%)  1 0/24 (0.00%)  0 0/14 (0.00%)  0 0/9 (0.00%)  0 0/13 (0.00%)  0
Pruritus  1  1/23 (4.35%)  1 0/24 (0.00%)  0 0/14 (0.00%)  0 0/9 (0.00%)  0 0/13 (0.00%)  0
erythema  1  0/23 (0.00%)  0 0/24 (0.00%)  0 1/14 (7.14%)  1 0/9 (0.00%)  0 0/13 (0.00%)  0
1
Term from vocabulary, MedDRA 19.0
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Flavio Mantelli, MD, PhD
Organization: Dompé
Phone: 02 583831
EMail: info@dompe.com
Layout table for additonal information
Responsible Party: Dompé Farmaceutici S.p.A
ClinicalTrials.gov Identifier: NCT02227147     History of Changes
Other Study ID Numbers: NGF0214
First Submitted: August 26, 2014
First Posted: August 27, 2014
Results First Submitted: January 25, 2019
Results First Posted: June 14, 2019
Last Update Posted: June 14, 2019