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Clinical Effects and Safety of 3% Diquafosol After Cataract Surgery

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: NCT02608489
Recruitment Status : Completed
First Posted : November 18, 2015
Results First Posted : October 17, 2016
Last Update Posted : October 17, 2016
Sponsor:
Information provided by (Responsible Party):
Jin Kwon Chung, Soonchunhyang University Hospital

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Dry Eye Syndromes
Interventions Drug: Diquafosol (Diquas)
Drug: Sodium Hyaluronate (Hyalein)
Enrollment 86
Recruitment Details Consecutive patients aged 20–90 years with bilateral or unilateral cataract undergoing uncomplicated phacoemulsification and intraocular lens (IOL) implantation at Soonchunhyang University Hospital between January 1, 2014 and January 31, 2015 were enrolled.
Pre-assignment Details  
Arm/Group Title Diqufosol Hyaluronate
Hide Arm/Group Description

3% Diquafosol Tetrasodium Ophthalmic Solution

Diquafosol (Diquas): Diquafosol group used diquafosol 6 times a day during study period.

0.1% Sodium Hyaluronate Ophthalmic Solution

Sodium Hyaluronate (Hyalein): Hyaluronate group used sodium hyaluronate 6 times a day during study period.

Period Title: Overall Study
Started 43 43
Completed 30 33
Not Completed 13 10
Arm/Group Title Diqufosol Hyaluronate Total
Hide Arm/Group Description

3% Diquafosol Tetrasodium Ophthalmic Solution

Diquafosol (Diquas): Diquafosol group used diquafosol 6 times a day during study period.

0.1% Sodium Hyaluronate Ophthalmic Solution

Sodium Hyaluronate (Hyalein): Hyaluronate group used sodium hyaluronate 6 times a day during study period.

Total of all reporting groups
Overall Number of Baseline Participants 30 33 63
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 30 participants 33 participants 63 participants
65.53  (11.15) 65.37  (10.02) 65.45  (10.62)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants 33 participants 63 participants
Female
18
  60.0%
24
  72.7%
42
  66.7%
Male
12
  40.0%
9
  27.3%
21
  33.3%
Obstructive Meibomian Gland Dysfunction (MGD)  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 30 participants 33 participants 63 participants
None 17 19 36
Mild 13 14 27
Ocular Surface Disease Index ± SD   [1] 
Mean (Standard Deviation)
Unit of measure:  Scores on a scale
Number Analyzed 30 participants 33 participants 63 participants
22.23  (14.65) 23.64  (16.62) 22.96  (15.11)
[1]
Measure Description: scale ranges (0-100). Higher values represent a worse outcome.
tear Break-Up Time ± SD  
Mean (Standard Deviation)
Unit of measure:  Seconds
Number Analyzed 30 participants 33 participants 63 participants
4.88  (2.52) 4.54  (1.85) 4.70  (2.06)
Schirmer test ± SD  
Mean (Standard Deviation)
Unit of measure:  Mm
Number Analyzed 30 participants 33 participants 63 participants
3.52  (4.13) 3.67  (2.88) 3.58  (3.31)
Fluorescein staining score ± SD   [1] 
Mean (Standard Deviation)
Unit of measure:  Score
Number Analyzed 30 participants 33 participants 63 participants
1.62  (1.77) 1.77  (1.73) 1.69  (1.75)
[1]
Measure Description:

Instillation of fluorescein in both eyes. After 1 or 2 full blinks, the intensity of staining of both cornea was scored. According to the National Eye Institute (NEI) workshop grading system, the cornea was divided into five sections. The minimum staining score was 0 and the maximum staining score was 15 points (up to 3 points for each section).

0 : best score (no corneal damage) 15 : worst score (severe corneal damages)

Lissamine green staining score ± SD   [1] 
Mean (Standard Deviation)
Unit of measure:  Score
Number Analyzed 30 participants 33 participants 63 participants
1.55  (1.19) 1.94  (1.56) 1.79  (1.38)
[1]
Measure Description:

Instillation of 1% lissamine green in both eyes. After 1 or 2 full blinks, the intensity of staining of both medial and lateral bulbar conjunctiva was cored. According to the National Eye Institute (NEI) workshop grading system, the conjunctiva was divided into six sections. The minimum staining score was 0 and the maximum staining score was 18 points (up to 3 points for each section).

0 : best score (no conjunctival damage) 18 : worst score (severe conjunctival damages)

Total High Order Aberration (HOA) changes ± SD  
Mean (Standard Deviation)
Unit of measure:  Microns
Number Analyzed 30 participants 33 participants 63 participants
0.042  (0.041) 0.041  (0.048) 0.041  (0.045)
Uncorrected visual acuity (LogMAR) ± SD  
Mean (Standard Deviation)
Unit of measure:  logMAR
Number Analyzed 30 participants 33 participants 63 participants
0.80  (0.52) 0.77  (0.45) 0.78  (0.47)
Grade of anterior chamber cells   [1] 
Mean (Standard Deviation)
Unit of measure:  Grade
Number Analyzed 30 participants 33 participants 63 participants
0  (0) 0  (0) 0  (0)
[1]
Measure Description:

Grade ranges (0-4+), Evaluate cells using slit-lamp biomicroscopy. The slit beam should be 1mm x 1mm.

Grade 0 : < 1 cell in field, Grade 0.5+ : 1-5 cells in field, Grade 1+ : 6-15 cells in field, Grade 2+ : 16-25 cells in fields Grade 3+ : 26-50 cells in field, Grade 4+ : 50+ cells in fields

1.Primary Outcome
Title an Ocular Surface Disease Index (OSDI) Questionnaire That is Related to Dry Eye Severity.
Hide Description The OSDI questionnaire consists of 12 questions that evaluate subjective symptoms related to dry eye and vision The score ranges were between 0 and 100 scores and the higher scores represent a worse outcome.
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Diqufosol Hyaluronate
Hide Arm/Group Description:

3% Diquafosol Tetrasodium Ophthalmic Solution

Diquafosol (Diquas): Diquafosol group used diquafosol 6 times a day during study period.

0.1% Sodium Hyaluronate Ophthalmic Solution

Sodium Hyaluronate (Hyalein): Hyaluronate group used sodium hyaluronate 6 times a day during study period.

Overall Number of Participants Analyzed 30 33
Overall Number of Units Analyzed
Type of Units Analyzed: Eyes
45 49
Mean (Standard Deviation)
Unit of Measure: scores on a scale
Baseline 21.09  (3.86) 23.00  (2.66)
Postoperative week 1 31.28  (5.49) 20.31  (4.63)
Postoperative week 4 20.31  (4.63) 23.00  (3.19)
Postoperative week 12 9.76  (7.95) 16.92  (13.11)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Diqufosol, Hyaluronate
Comments To obtain an overall comparison between treatment responses throughout the study period considering the 2 levels of correlation in subjects and follow-up, a linear mixed model with asymmetric random effects was used.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.221
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Diqufosol, Hyaluronate
Comments Linear mixed model was used to compare measurement data between the 2 groups by considering the correlation between both eyes of each patient at postoperative week 12 follow-up.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.015
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
2.Primary Outcome
Title Schirmer I Test Without Anesthesia That is Related to Dry Eye Severity.
Hide Description Schirmer paper strips were placed into the temporal one third of the lower conjunctival sac for 5 min and the wetness on the strips was measured.
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Diqufosol Hyaluronate
Hide Arm/Group Description:

3% Diquafosol Tetrasodium Ophthalmic Solution

Diquafosol (Diquas): Diquafosol group used diquafosol 6 times a day during study period.

0.1% Sodium Hyaluronate Ophthalmic Solution

Sodium Hyaluronate (Hyalein): Hyaluronate group used sodium hyaluronate 6 times a day during study period.

Overall Number of Participants Analyzed 30 33
Overall Number of Units Analyzed
Type of Units Analyzed: Eyes
45 49
Mean (Standard Deviation)
Unit of Measure: mm
Baseline 3.61  (0.84) 3.69  (0.58)
Postoperative week 1 2.03  (0.37) 1.76  (0.25)
Postoperative week 4 3.22  (0.62) 2.59  (0.43)
Postoperative week 12 4.10  (2.87) 2.52  (2.08)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Diqufosol, Hyaluronate
Comments To obtain an overall comparison between treatment responses throughout the study period considering the 2 levels of correlation in subjects and follow-up, a linear mixed model with asymmetric random effects was used.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.256
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Diqufosol, Hyaluronate
Comments Linear mixed model was used to compare measurement data between the 2 groups by considering the correlation between both eyes of each patient at Postoperative week 12 follow-up.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.025
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
3.Primary Outcome
Title Changes in HOAs After Blinking That is Related to Dry Eye Severity.
Hide Description Corneal HOAs and serial measurement of ocular total HOAs were evaluated using a KR-1W wavefront analyzer (Topcon Medical System, Inc., Tokyo, Japan). Serial measurement of total ocular HOAs was measured every second for 10 s after complete blinking in continuous measurement mode. The difference between the fifth and first HOA was used to evaluate the tear film instability.
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Diqufosol Hyaluronate
Hide Arm/Group Description:

3% Diquafosol Tetrasodium Ophthalmic Solution

Diquafosol (Diquas): Diquafosol group used diquafosol 6 times a day during study period.

0.1% Sodium Hyaluronate Ophthalmic Solution

Sodium Hyaluronate (Hyalein): Hyaluronate group used sodium hyaluronate 6 times a day during study period.

Overall Number of Participants Analyzed 30 33
Overall Number of Units Analyzed
Type of Units Analyzed: Eyes
45 49
Mean (Standard Deviation)
Unit of Measure: microns
Baseline 0.042  (0.010) 0.041  (0.007)
Postoperative week 1 0.153  (0.057) 0.260  (0.040)
Postoperative week 4 0.067  (0.029) 0.074  (0.043)
Postoperative week 12 0.034  (0.040) 0.039  (0.147)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Diqufosol, Hyaluronate
Comments To obtain an overall comparison between treatment responses throughout the study period considering the 2 levels of correlation in subjects and follow-up, a linear mixed model with asymmetric random effects was used.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.080
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Diqufosol, Hyaluronate
Comments Linear mixed model was used to compare measurement data between the 2 groups by considering the correlation between both eyes of each patient at postoperative week 12 follow-up.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.021
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
4.Primary Outcome
Title Tear Break-up Time (TBUT) That is Related to Dry Eye Severity.
Hide Description TBUT was assessed by instillation of a drop of 2% sterile fluorescein into the conjunctival sac and recording the interval between the last complete blink and the first appearance of a dry spot or disruption of the tear film.
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Diqufosol Hyaluronate
Hide Arm/Group Description:

3% Diquafosol Tetrasodium Ophthalmic Solution

Diquafosol (Diquas): Diquafosol group used diquafosol 6 times a day during study period.

0.1% Sodium Hyaluronate Ophthalmic Solution

Sodium Hyaluronate (Hyalein): Hyaluronate group used sodium hyaluronate 6 times a day during study period.

Overall Number of Participants Analyzed 30 33
Overall Number of Units Analyzed
Type of Units Analyzed: Eyes
45 49
Mean (Standard Deviation)
Unit of Measure: seconds
Baseline 4.98  (0.53) 4.50  (0.36)
Postoperative week 1 3.50  (1.35) 3.00  (1.16)
Postoperative week 4 5.64  (1.89) 3.96  (1.46)
Postoperative week 12 6.69  (2.23) 4.38  (1.92)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Diqufosol, Hyaluronate
Comments To obtain an overall comparison between treatment responses throughout the study period considering the 2 levels of correlation in subjects and follow-up, a linear mixed model with asymmetric random effects was used.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Diqufosol, Hyaluronate
Comments Linear mixed model was used to compare measurement data between the 2 groups by considering the correlation between both eyes of each patient at postoperative week 4
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Diqufosol, Hyaluronate
Comments Linear mixed model was used to compare measurement data between the 2 groups by considering the correlation between both eyes of each patient at postoperative week 12
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
5.Primary Outcome
Title Corneal Fluorescein Staining That is Related to Dry Eye Severity.
Hide Description

Ocular surface damage was assessed by the National Eye Institute (NEI) workshop grading system, and corneal fluorescein staining was evaluated. Instillation of fluorescein in both eyes. After 1 or 2 full blinks, the intensity of staining of both cornea was scored. According to the National Eye Institute (NEI) workshop grading system, the cornea was divided into five sections. The minimum staining score was 0 and the maximum staining score was 15 points (up to 3 points for each section).

0 : best score (no corneal damage) 15 : worst score (severe corneal damages)

Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Diqufosol Hyaluronate
Hide Arm/Group Description:

3% Diquafosol Tetrasodium Ophthalmic Solution

Diquafosol (Diquas): Diquafosol group used diquafosol 6 times a day during study period.

0.1% Sodium Hyaluronate Ophthalmic Solution

Sodium Hyaluronate (Hyalein): Hyaluronate group used sodium hyaluronate 6 times a day during study period.

Overall Number of Participants Analyzed 30 33
Overall Number of Units Analyzed
Type of Units Analyzed: Eyes
45 49
Mean (Standard Deviation)
Unit of Measure: scores
Baseline 1.52  (0.41) 1.78  (0.28)
Postoperative week 1 2.09  (0.45) 2.88  (0.31)
Postoperative week 4 1.09  (0.33) 1.73  (0.23)
Postoperative week 12 0.48  (0.77) 1.21  (1.45)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Diqufosol, Hyaluronate
Comments To obtain an overall comparison between treatment responses throughout the study period considering the 2 levels of correlation in subjects and follow-up, a linear mixed model with asymmetric random effects was used.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.045
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
6.Primary Outcome
Title Lissamine Green (LG) Conjunctival Staining That is Related to Dry Eye Severity
Hide Description

Ocular surface damage was assessed by the National Eye Institute (NEI) workshop grading system, and conjunctival LG staining were evaluated. Instillation of 1% lissamine green in both eyes. After 1 or 2 full blinks, the intensity of staining of both medial and lateral bulbar conjunctiva was cored. According to the National Eye Institute (NEI) workshop grading system, the conjunctiva was divided into six sections. The minimum staining score was 0 and the maximum staining score was 18 points (up to 3 points for each section).

0 : best score (no conjunctival damage) 18 : worst score (severe conjunctival damages)

Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Diqufosol Hyaluronate
Hide Arm/Group Description:

3% Diquafosol Tetrasodium Ophthalmic Solution

Diquafosol (Diquas): Diquafosol group used diquafosol 6 times a day during study period.

0.1% Sodium Hyaluronate Ophthalmic Solution

Sodium Hyaluronate (Hyalein): Hyaluronate group used sodium hyaluronate 6 times a day during study period.

Overall Number of Participants Analyzed 30 33
Overall Number of Units Analyzed
Type of Units Analyzed: Eyes
45 49
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
Baseline 1.40  (0.32) 1.91  (0.22)
Postoperative week 1 2.56  (0.73) 3.86  (0.50)
Postoperative week 4 0.86  (1.18) 2.31  (2.12)
Postoperative week 12 0.36  (0.76) 1.33  (2.04)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Diqufosol, Hyaluronate
Comments To obtain an overall comparison between treatment responses throughout the study period considering the 2 levels of correlation in subjects and follow-up, a linear mixed model with asymmetric random effects was used.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Diqufosol, Hyaluronate
Comments Linear mixed model was used to compare measurement data between the 2 groups by considering the correlation between both eyes of each patient at postoperative week 4
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.002
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Diqufosol, Hyaluronate
Comments Linear mixed model was used to compare measurement data between the 2 groups by considering the correlation between both eyes of each patient at postoperative week 12
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.034
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
7.Secondary Outcome
Title Grades of Anterior Chamber Cells.
Hide Description

Anterior chamber inflammation was examined with a slit-lamp clinically, and divided into six grades using the Standardization of Uveitis Nomenclature (SUN) working group grading scheme.

grade 0 : <1 cell in field, grade 0.5 : 1-5 cells in field, grade 1 : 6-15 cells in field, grade 2 : 16-25 cells in field grade 3 : 26-50 cells in field, grade 4 : >50 cells in field Field size is a 1 mm X 1 mm slit beam

Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Diqufosol Hyaluronate
Hide Arm/Group Description:

3% Diquafosol Tetrasodium Ophthalmic Solution

Diquafosol (Diquas): Diquafosol group used diquafosol 6 times a day during study period.

0.1% Sodium Hyaluronate Ophthalmic Solution

Sodium Hyaluronate (Hyalein): Hyaluronate group used sodium hyaluronate 6 times a day during study period.

Overall Number of Participants Analyzed 30 33
Overall Number of Units Analyzed
Type of Units Analyzed: Eyes
45 49
Mean (Standard Deviation)
Unit of Measure: grade
Baseline 0  (0) 0  (0)
Postoperative week 1 1.54  (0.34) 1.78  (0.25)
Postoperative week 4 0.16  (0.26) 0.36  (0.22)
Postoperative week 12 0  (0) 0  (0)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Diqufosol, Hyaluronate
Comments To obtain an overall comparison between treatment responses throughout the study period considering the 2 levels of correlation in subjects and follow-up, a linear mixed model with asymmetric random effects was used.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.151
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
8.Secondary Outcome
Title Number of Participants Who Stop Using the Eye Drops Due to Drug-related Discomfort
Hide Description Drug-related discomfort is defined as having started after eye drop instillation and lasting several minutes, occurring every time during instillation at any time up to 12 weeks into the follow-up period. Patients that had any adverse events or wanted to stop using the eye drops were excluded from the study, but these patients were included in the safety evaluation.
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Overall, 1 of 31 patients (3.22%), a 64-year-old man who underwent bilateral sequential same-day cataract surgery, stopped using the study eye drops owing to severe irritation in the D group.
Arm/Group Title Diqufosol Hyaluronate
Hide Arm/Group Description:

3% Diquafosol Tetrasodium Ophthalmic Solution

Diquafosol (Diquas): Diquafosol group used diquafosol 6 times a day during study period.

0.1% Sodium Hyaluronate Ophthalmic Solution

Sodium Hyaluronate (Hyalein): Hyaluronate group used sodium hyaluronate 6 times a day during study period.

Overall Number of Participants Analyzed 31 33
Measure Type: Number
Unit of Measure: participants
1 0
Time Frame 12 weeks
Adverse Event Reporting Description Patients that had any adverse events or wanted to stop using the eye drops were excluded from the study, but these patients were included in the safety evaluation.
 
Arm/Group Title Diqufosol Hyaluronate
Hide Arm/Group Description

3% Diquafosol Tetrasodium Ophthalmic Solution

Diquafosol (Diquas): Diquafosol group used diquafosol 6 times a day during study period.

0.1% Sodium Hyaluronate Ophthalmic Solution

Sodium Hyaluronate (Hyalein): Hyaluronate group used sodium hyaluronate 6 times a day during study period.

All-Cause Mortality
Diqufosol Hyaluronate
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
Diqufosol Hyaluronate
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/31 (0.00%)      0/33 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 3.23%
Diqufosol Hyaluronate
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/31 (3.23%)      0/33 (0.00%)    
Eye disorders     
Severe irritation [1]  1/31 (3.23%)  1 0/33 (0.00%)  0
[1]
64-year-old man who underwent bilateral sequential same-day cataract surgery, stopped using the study eye drops owing to severe irritation in the D group.
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: Dr. JinKwon Chung
Organization: Soonchunhyang University Hospital
Phone: 82-2-709-9354
EMail: schcornea@schmc.ac.kr
Layout table for additonal information
Responsible Party: Jin Kwon Chung, Soonchunhyang University Hospital
ClinicalTrials.gov Identifier: NCT02608489    
Other Study ID Numbers: SCHUH 2013-12-012
First Submitted: November 14, 2015
First Posted: November 18, 2015
Results First Submitted: April 14, 2016
Results First Posted: October 17, 2016
Last Update Posted: October 17, 2016