Dose-Response Study of DE-089 Ophthalmic Solution in Patients With Dry Eye -Late Phase II Confirmatory Study-
Overview
- Phase
- Phase 2
- Intervention
- DE-089 ophthalmic solution
- Conditions
- Dry Eye
- Sponsor
- Santen Pharmaceutical Co., Ltd.
- Enrollment
- 320
- Locations
- 1
- Primary Endpoint
- Mean Change in Fluorescein Staining Score From Baseline
- Status
- Completed
- Last Updated
- 11 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Arms & Interventions
High concentration
Intervention: DE-089 ophthalmic solution
Low concentration
Intervention: DE-089 ophthalmic solution
Placebo
Intervention: Placebo ophthalmic solution
Outcomes
Primary Outcomes
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.