A Study to Determine the Safety and Tolerability of Escalating Doses of INS365 Ophthalmic Solution

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 2

Conditions: Dry Eye Disease

Treatments: Drug: diquafosol tetrasodium (INS365) ophthalmic solution

Study type: Interventional

Funder types: Industry

Identifiers

NCT00680108

03-102

Details and patient eligibility

About

The purpose of this study is to evaluate the safety and tolerability of INS365 Ophthalmic Solution when applied topically as eyedrops in patients with mild to moderate dry eye disease.

Enrollment: 62 estimated patients

Sex

Volunteers: No Healthy Volunteers

Inclusion criteria

• Best corrected visual acuity 20/40 in each eye
• 2 out 5 specified symptoms
• Corneal fluorescein staining score greater than or equal to 3 out of 15

Exclusion criteria

• Unable to stop concomitant medications
• Have had intraocular surgery in previous 90 days
• Have excluded systemic or ocular disease
• Wear contact lenses and are not willing to remove them
• Have intraocular pressure greater than 22 mg Hg

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind