A Double-masked, Randomized, Placebo-controlled,Pilot Study of Diquafosol Tetrasodium in Subjects Following Photorefractive Keratectomy (PRK)

Phase 2TerminatedNCT01381731

Merck Sharp & Dohme LLC14 enrolled

Overview

The objectives of this trial are to: * Assess the safety and tolerability of diquafosol tetrasodium ophthalmic solution versus placebo following one week of treatment in subjects undergoing photorefractive keratectomy (PRK). * Evaluate the potential of diquafosol to accelerate corneal wound healing/re-epithelialization following PRK.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Photorefractive Keratectomy

Interventions

diquafosol tetrasodium ophthalmic solution 2%DRUG

opthalmic solution 2 drops in each eye QID

placeboDRUG

opthalmic solution 2 drops in each eye QID

Eligibility

Sex: ALLMin age: 18 YearsMax age: 45 Years

Medical Language ↔ Plain English

Inclusion Criteria: * between age 18 - 45 years old * candidate for bilateral PRK Exclusion Criteria: * dry eye disease * any corneal pathologies * previous corneal or intraocular surgeries

Outcomes

Primary Outcomes

Healing time

Time frame: 12 weeks

Secondary Outcomes

Adverse events

Time frame: 12 weeks

Data from ClinicalTrials.gov

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