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 -
Overview
- Phase
- Phase 3
- Intervention
- 3% DE-089 ophthalmic solution
- Conditions
- Dry Eye
- Sponsor
- Santen Pharmaceutical Co., Ltd.
- Enrollment
- 332
- Locations
- 1
- Primary Endpoint
- Mean Change in Fluorescein Staining Score From Baseline
- Status
- Completed
- Last Updated
- 11 years ago
Overview
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.
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
3% DE-089
Intervention: 3% DE-089 ophthalmic solution
0.1% HA
Intervention: 0.1% sodium hyaluronate 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.
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.