Overview

Phase III Confirmatory Study of DE-089 Ophthalmic Solution in Patients With Dry Eye

Status:
Completed
Trial end date:
1969-12-31
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 3
Details
Lead Sponsor:
Santen Pharmaceutical Co., Ltd.
Treatments:
Hyaluronic Acid
Ophthalmic Solutions
Pharmaceutical Solutions
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