Late Phase II Confirmatory Study of DE-089 Ophthalmic Solution in Patients With Dry Eye
- Conditions
- Dry Eye
- Interventions
- Drug: DE-089 ophthalmic solutionDrug: Placebo ophthalmic solution
- Registration Number
- NCT01189032
- Lead Sponsor
- Santen Pharmaceutical Co., Ltd.
- Brief Summary
Dose response related to efficacy and safety of DE-089 ophthalmic solution are examined in patients with dry eye, using a multicenter, randomized, double-blind, parallel group comparison study, and the optimal concentration is determined.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 320
-
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 High concentration DE-089 ophthalmic solution - Low concentration DE-089 ophthalmic solution - Placebo Placebo 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Santen study sites
🇯🇵Osaka, Japan