Late Phase II 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

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.

• Phase: Phase 2

Details

• Lead Sponsor: Santen Pharmaceutical Co., Ltd.
• Treatments: 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