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Study of SAF312 as an Eye Drop for Treatment of Eye Pain Following Photorefractive Keratectomy (PRK) Surgery

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ClinicalTrials.gov Identifier: NCT02961062
Recruitment Status : Completed
First Posted : November 10, 2016
Results First Posted : April 11, 2019
Last Update Posted : April 11, 2019
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Study Type Interventional
Study Design Intervention Model: Crossover Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Postoperative Ocular Pain After PRK Surgery
Interventions Drug: SAF312
Drug: Placebo
Enrollment 40
Recruitment Details A total of 40 patients were randomized in a 1:1 ratio to two treatment sequences: SAF312 followed by Vehicle, or Vehicle followed by SAF312.
Pre-assignment Details Bilateral crossover design: A crossover design was utilized in order to decrease the inter-patient variability due to different pain tolerance in different individuals.
Arm/Group Title Treatment Sequence 1 Treatment Sequence 2
Hide Arm/Group Description Vehicle/SAF312 SAF312 / Vehicle
Period Title: Overall Study
Started 20 20
Completed 20 20
Not Completed 0 0
Arm/Group Title Treatment Sequence 1 Treatment Sequence 2 Total
Hide Arm/Group Description Vehicle/SAF312 SAF312 / Vehicle Total of all reporting groups
Overall Number of Baseline Participants 20 20 40
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 20 participants 20 participants 40 participants
34.4  (10.77) 33.7  (8.94) 34.0  (9.78)
Sex/Gender, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 20 participants 40 participants
male
11
  55.0%
10
  50.0%
21
  52.5%
female
9
  45.0%
10
  50.0%
19
  47.5%
Race/Ethnicity, Customized   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 20 participants 40 participants
white
18
  90.0%
17
  85.0%
35
  87.5%
asian
2
  10.0%
1
   5.0%
3
   7.5%
Black
0
   0.0%
1
   5.0%
1
   2.5%
multiple
0
   0.0%
1
   5.0%
1
   2.5%
[1]
Measure Description: Race
Race/Ethnicity, Customized   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 20 participants 40 participants
non hispanic latino
19
  95.0%
18
  90.0%
37
  92.5%
hispanic latino
1
   5.0%
2
  10.0%
3
   7.5%
[1]
Measure Description: Ethnicity
1.Primary Outcome
Title Visual Analog Scale (VAS) Pre-dose Pain Assessment
Hide Description VAS pain severity scale pre-dose, 6 hours post-operatively. The Visual Analog Scale (VAS) is a commonly used measurement of pain, discomfort, that goes from 0 meaning no pain to 100 meaning worst imaginable pain
Time Frame 6 hours
Hide Outcome Measure Data
Hide Analysis Population Description
Primary PD Analysis set
Arm/Group Title SAF312 Vehicle
Hide Arm/Group Description:
treatment participants from both sequences
comparator participants from both sequences
Overall Number of Participants Analyzed 40 40
Mean (Standard Error)
Unit of Measure: score on a scale
34.63  (4.05) 45.76  (4.10)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection SAF312, Vehicle
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.005
Comments [Not Specified]
Method Kenward-Roger method
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -11.1
Confidence Interval (2-Sided) 90%
-17.54 to -4.71
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0
Estimation Comments [Not Specified]
2.Primary Outcome
Title Average Ocular Pain VAS Assessments
Hide Description VAS pain severity scale from the first post-operative assessment to pre-dose 12 hours post-operative assesment The Visual Analog Scale (VAS) is a commonly used measurement of pain, discomfort, that goes from 0 meaning no pain to 100 meaning worst imaginable pain
Time Frame 12 hours
Hide Outcome Measure Data
Hide Analysis Population Description
Primary PD Analysis set
Arm/Group Title SAF312 Vehicle
Hide Arm/Group Description:
treatment participants from both sequences
comparator participants from both sequences
Overall Number of Participants Analyzed 40 40
Mean (Standard Error)
Unit of Measure: score on a scale
30.90  (4.07) 39.47  (4.11)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection SAF312, Vehicle
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.017
Comments [Not Specified]
Method Kenward-Roger method
Comments [Not Specified]
Method of Estimation Estimation Parameter Median Difference (Final Values)
Estimated Value -8.56
Confidence Interval (2-Sided) 90%
-14.29 to -2.83
Parameter Dispersion
Type: Standard Error of the Mean
Value: 3.37
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Incidence of and Amount of Rescue Oral Analgesics (Number of Participants Who Did Not Use Oral Rescue Medication)
Hide Description Summary of oral rescue medication use incidence (number of patients who DID NOT use oral rescue medication)
Time Frame 6,12, 24, 48 and 72 hours post-operatievly
Hide Outcome Measure Data
Hide Analysis Population Description
Secondary PD analysis set
Arm/Group Title SAF312 Vehicle
Hide Arm/Group Description:
treatment participants from both sequences
comparator participants from both sequences
Overall Number of Participants Analyzed 40 40
Measure Type: Count of Participants
Unit of Measure: Participants
0-6 hours post-operatively
23
  57.5%
19
  47.5%
0-12 hours post-operatively
19
  47.5%
16
  40.0%
0-24 hours post-operatively
16
  40.0%
12
  30.0%
0-48 hours post-operatively
11
  27.5%
11
  27.5%
0-72 hours post-operatively
11
  27.5%
11
  27.5%
4.Secondary Outcome
Title VAS Pain Assessments
Hide Description VAS pain assessment during the first 72 hours post-operatively. VAS pain severity scale from the first post-operative assessment to pre-dose 12 hours post-operative assesment The Visual Analog Scale (VAS) is a commonly used measurement of pain, discomfort, that goes from 0 meaning no pain to 100 meaning worst imaginable pain
Time Frame 72 hours
Hide Outcome Measure Data
Hide Analysis Population Description
Primary PD Analysis set
Arm/Group Title SAF312 Vehicle
Hide Arm/Group Description:
treatment participants from both sequences
comparator participants from both sequences
Overall Number of Participants Analyzed 40 40
Mean (Standard Error)
Unit of Measure: score on a scale
5.13  (4.05) 3.58  (4.10)
5.Secondary Outcome
Title Plasma Concentration of SAF312
Hide Description C Max
Time Frame day1, day 4
Hide Outcome Measure Data
Hide Analysis Population Description
PK Analysis set
Arm/Group Title SAF312 Vehicle
Hide Arm/Group Description:
treatment participants from both sequences
comparator participants from both sequences
Overall Number of Participants Analyzed 40 40
Mean (Standard Deviation)
Unit of Measure: ng/mL
day 1 Number Analyzed 34 participants 0 participants
0.454  (0.227)
day 4 Number Analyzed 33 participants 0 participants
2.40  (1.53)
Time Frame approximately 15 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title SAF312 Vehicle
Hide Arm/Group Description treatment participants from both sequences Vehicle
All-Cause Mortality
SAF312 Vehicle
Affected / at Risk (%) Affected / at Risk (%)
Total   0/40 (0.00%)   0/40 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
SAF312 Vehicle
Affected / at Risk (%) Affected / at Risk (%)
Total   0/40 (0.00%)   0/40 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
SAF312 Vehicle
Affected / at Risk (%) Affected / at Risk (%)
Total   8/40 (20.00%)   5/40 (12.50%) 
Ear and labyrinth disorders     
Tinnitus  1  0/40 (0.00%)  1/40 (2.50%) 
Eye disorders     
Corneal infiltrates  1  0/40 (0.00%)  1/40 (2.50%) 
Corneal opacity  1  1/40 (2.50%)  1/40 (2.50%) 
Punctate keratitis  1  1/40 (2.50%)  1/40 (2.50%) 
Vitreous detachment  1  1/40 (2.50%)  0/40 (0.00%) 
Gastrointestinal disorders     
Vomiting  1  1/40 (2.50%)  0/40 (0.00%) 
General disorders     
Pyrexia  1  1/40 (2.50%)  0/40 (0.00%) 
Infections and infestations     
Nasopharyngitis  1  2/40 (5.00%)  0/40 (0.00%) 
Sinusitis  1  1/40 (2.50%)  0/40 (0.00%) 
Musculoskeletal and connective tissue disorders     
Arthralgia  1  1/40 (2.50%)  0/40 (0.00%) 
Nervous system disorders     
Headache  1  1/40 (2.50%)  1/40 (2.50%) 
Respiratory, thoracic and mediastinal disorders     
Oropharyngeal pain  1  1/40 (2.50%)  0/40 (0.00%) 
Sinus congestion  1  1/40 (2.50%)  0/40 (0.00%) 
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 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.
The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (ie, data from all sites) in the clinical trial.
Results Point of Contact
Name/Title: Study Director
Organization: Novartis Pharmaceuticals
Phone: 862-778-8300
Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT02961062     History of Changes
Other Study ID Numbers: CSAF312X2201
First Submitted: November 8, 2016
First Posted: November 10, 2016
Results First Submitted: February 19, 2019
Results First Posted: April 11, 2019
Last Update Posted: April 11, 2019