Phase III Confirmatory Study of DE-089 Ophthalmic Solution in Patients With Dry Eye
- Conditions
- Dry Eye
- Interventions
- Drug: 3% DE-089 ophthalmic solution
- Registration Number
- NCT01240382
- Lead Sponsor
- Santen Pharmaceutical Co., Ltd.
- Brief Summary
To investigate that the efficacy of 3% DE-089 ophthalmic solution (one drop at a time, 6 times daily, 4 weeks topical administration), in comparison to 0.1% sodium hyaluronate ophthalmic solution (0.1% HA) (one drop at a time, 6 times daily, 4 weeks topical administration), is at least non-inferior in the change in fluorescein staining score, and is superior in the change in Rose bengal score, in a multicenter, double-masked, parallel-group comparison study. Safety profile will likewise be compared.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 332
-
Those who show:
- Keratoconjunctival disorder confirmed with vital dye staining
- Abnormal Schirmer score results
- Eye disease that needs therapy other than that for dry eye
- Those who need to wear contact lenses during the clinical study
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description 0.1% HA 0.1% sodium hyaluronate ophthalmic solution - 3% DE-089 3% DE-089 ophthalmic solution -
- Primary Outcome Measures
Name Time Method Mean Change in Fluorescein Staining Score From Baseline 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 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Santen study sites
🇯🇵Osaka, Japan