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Phase III Confirmatory Study of DE-089 Ophthalmic Solution in Patients With Dry Eye

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: NCT01240382
Recruitment Status : Completed
First Posted : November 15, 2010
Results First Posted : August 8, 2014
Last Update Posted : August 13, 2014
Sponsor:
Information provided by:
Santen Pharmaceutical Co., Ltd.

Study Type Interventional
Condition Dry Eye
Interventions Drug: 3% DE-089 ophthalmic solution
Drug: 0.1% sodium hyaluronate ophthalmic solution
Enrollment 332
Recruitment Details  
Pre-assignment Details Informed consent was obtained from 332 patients, of whom 287 were randomized and prescribed the study drug.
Arm/Group Title 3% DE-089 0.1% HA
Hide Arm/Group Description 3% DE-089 ophthalmic solution 0.1% sodium hyaluronate ophthalmic solution
Period Title: Overall Study
Started 144 143
Completed 142 139
Not Completed 2 4
Reason Not Completed
Adverse Event             2             1
Lack of Efficacy             0             2
Fear of adverse events             0             1
Arm/Group Title 3% DE-089 0.1% HA Total
Hide Arm/Group Description 3% DE-089 ophthalmic solution 0.1% sodium hyaluronate ophthalmic solution Total of all reporting groups
Overall Number of Baseline Participants 144 143 287
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 144 participants 143 participants 287 participants
55.3  (17.1) 57.0  (16.8) 56.1  (16.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 144 participants 143 participants 287 participants
Female
120
  83.3%
125
  87.4%
245
  85.4%
Male
24
  16.7%
18
  12.6%
42
  14.6%
1.Primary Outcome
Title Mean Change in Fluorescein Staining Score From Baseline
Hide Description

Fluorescein staining was scored according to the protocol by Shimmura et al. The cornea was divided into 3 equal zones: upper, middle, and lower. Each zone had a staining score ranging between 0 and 3 points, with minimum and maximum total staining scores ranging between 0 and 9 points. 0 is better.

The degree of staining with Fluorescein dyes was scored as follows: 0 = no staining, 1= staining of less than half of the area, 2= staining of more than half of the area, 3= staining in the whole area.

Time Frame Baseline and 4-week (discontinued (LOCF))
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy analysis was performed full analysis set (FAS). In 0.1% sodium hyaluronate ophthalmic solution group, 1 subject was excluded from analysis because there was no available efficacy data in fluorescein staining.
Arm/Group Title 3% DE-089 0.1% HA
Hide Arm/Group Description:
3% DE-089 ophthalmic solution
0.1% sodium hyaluronate ophthalmic solution
Overall Number of Participants Analyzed 144 142
Mean (Standard Deviation)
Unit of Measure: points
-2.12  (1.66) -2.08  (1.52)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 3% DE-089, 0.1% HA
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority in mean change in fluorescein staining score from baseline was assessed on the non-inferiority margin (0.34) with the upper limit of the confidence interval of the difference between the 2 treatment groups.
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method l
Comments [Not Specified]
Method of Estimation Estimation Parameter Median Difference (Final Values)
Estimated Value -0.03
Confidence Interval 95%
-0.405 to 0.338
Estimation Comments [Not Specified]
2.Primary Outcome
Title Mean Change in Rose Bengal Staining Score From Baseline
Hide Description

Rose bengal staining were scored according to the protocol by Shimmura et al. The ocular surface was divided into 5 zones: nasal and temporal conjunctival, and upper, middle, and lower corneal areas. A staining score between 0 and 3 points was used in each zone, with the minimum and maximum total staining scores ranging between 0 and 15 points.0 is better.

The degree of staining with Rose bengal dyes was scored as follows: 0 = no staining, 1= staining of less than half of the area, 2= staining of more than half of the area, 3= staining in the whole area.

Time Frame Baseline and 4-week (discontinued (LOCF))
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy analysis was performed full analysis set (FAS). In 0.1% sodium hyaluronate ophthalmic solution group, 2 subjects were excluded from analysis because there was no available efficacy data in rose bengal staining.
Arm/Group Title 3% DE-089 0.1% HA
Hide Arm/Group Description:
3% DE-089 ophthalmic solution
0.1% sodium hyaluronate ophthalmic solution
Overall Number of Participants Analyzed 144 141
Mean (Standard Deviation)
Unit of Measure: points
-3.06  (2.27) -2.38  (2.08)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 3% DE-089, 0.1% HA
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.010
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Median Difference (Final Values)
Estimated Value -0.67
Confidence Interval 95%
-1.18 to -0.67
Estimation Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title 3% DE-089 0.1% HA
Hide Arm/Group Description 3% DE-089 ophthalmic solution 0.1% sodium hyaluronate ophthalmic solution
All-Cause Mortality
3% DE-089 0.1% HA
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
3% DE-089 0.1% HA
Affected / at Risk (%) Affected / at Risk (%)
Total   0/144 (0.00%)   1/143 (0.70%) 
Gastrointestinal disorders     
Gastrointestinal bleeding  [1]  0/144 (0.00%)  1/143 (0.70%) 
Indicates events were collected by systematic assessment
[1]
There was a serious adverse event in 0.1% sodium hyaluronate ophthalmic solution group
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
3% DE-089 0.1% HA
Affected / at Risk (%) Affected / at Risk (%)
Total   9/144 (6.25%)   1/143 (0.70%) 
Eye disorders     
Eye irritation   9/144 (6.25%)  1/143 (0.70%) 
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: General Manager of Clinical Development Group
Organization: Santen Pharmaceutical Co., Ltd.
Phone: +81-6-4802-9341
EMail: clinical@santen.co.jp
Layout table for additonal information
ClinicalTrials.gov Identifier: NCT01240382    
Other Study ID Numbers: 00890602
First Submitted: November 12, 2010
First Posted: November 15, 2010
Results First Submitted: May 23, 2014
Results First Posted: August 8, 2014
Last Update Posted: August 13, 2014