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
|
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Dry Eye | Drug: 3% DE-089 ophthalmic solution Drug: 0.1% sodium hyaluronate ophthalmic solution | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 332 participants |
Official Title: | Double-masked Comparison Study of DE-089 Ophthalmic Solution in Patients With Dry Eye (Multi-center Study, in Comparison to 0.1% Sodium Hyaluronate Ophthalmic Solution) - Phase III Confirmatory Study - |
Actual Primary Completion Date : | February 2008 |
Arm | Intervention/treatment |
---|---|
Experimental: 3% DE-089 |
Drug: 3% DE-089 ophthalmic solution |
Active Comparator: 0.1% HA |
Drug: 0.1% sodium hyaluronate ophthalmic solution |
- Mean Change in Fluorescein Staining Score From Baseline [ Time Frame: Baseline and 4-week (discontinued (LOCF)) ]
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.
- Mean Change in Rose Bengal Staining Score From Baseline [ Time Frame: Baseline and 4-week (discontinued (LOCF)) ]
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.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 20 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Inclusion Criteria:
-
Those who show:
- Keratoconjunctival disorder confirmed with vital dye staining
- Abnormal Schirmer score results
Exclusion Criteria:
- Eye disease that needs therapy other than that for dry eye
- Those who need to wear contact lenses during the clinical study

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01240382
Japan | |
Santen study sites | |
Osaka, Japan |
ClinicalTrials.gov Identifier: | NCT01240382 |
Other Study ID Numbers: |
00890602 |
First Posted: | November 15, 2010 Key Record Dates |
Results First Posted: | August 8, 2014 |
Last Update Posted: | August 13, 2014 |
Last Verified: | August 2014 |
Dry Eye Syndromes Keratoconjunctivitis Sicca Lacrimal Apparatus Diseases Eye Diseases Keratoconjunctivitis Conjunctivitis Conjunctival Diseases Keratitis Corneal Diseases |
Pharmaceutical Solutions Ophthalmic Solutions Hyaluronic Acid Adjuvants, Immunologic Immunologic Factors Physiological Effects of Drugs Viscosupplements Protective Agents |