A Study of INS365 Ophthalmic Solution in Patients With Moderate to Severe Dry Eye Disease

• Status: Completed
• Trial end date: 2000-07-01
• Target enrollment: 0
• Participant gender: All

Summary

To evaluate the efficacy and safety of INS365 Ophthalmic Solution when applied topically in patients with moderate to severe dry eye disease.

• Phase: Phase 2

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.
• Treatments: Ophthalmic Solutions; Pharmaceutical Solutions

Criteria

Inclusion Criteria:

• Best corrected visual acuity of at least +0.7 ETDRS

• Six month history of dry eye disease

• Mild severity in two out of five symptoms

• Unanesthetized Schirmer score of less than or equal to 7mm

• Corneal fluorescein staining greater than or equal to 4 out of 15 or lissamine green conjunctival staining of greater than or equal to 5 out of 18

Exclusion Criteria:

• Nasal stimulated Schirmer score of less than 3mm

• Have ongoing ocular infection

• Have congenitally absent meibomian or lacrimal glands

• Have had punctal occlusion within a specified time prior to study

• Wear contact lens and refuse to remove them

• Have other excluded eye conditions.