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

Phase 2

Terminated

• Conditions: Photorefractive Keratectomy
• Interventions: Drug: diquafosol tetrasodium ophthalmic solution 2%; Drug: placebo

• Registration Number: NCT01381731
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-04
• Primary Completion: 2005-06
• Study Completion: 2005-06
• Study First Submitted: 2011-06-23
• Study First Submitted QC: 2011-06-24
• Disposition First Submitted: 2011-06-24
• Disposition First Submitted QC: 2011-06-24
• Study First Posted: 2011-06-27
• Disposition First Posted: 2011-06-27
• Status Verified: 2015-10
• Last Update Submitted: 2015-10-29
• Last Update Posted: 2015-11-25

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 14

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Diquafosol tetrasodium ophthalmic solution 2%	diquafosol tetrasodium ophthalmic solution 2%	topical ophthalmic solution
Placebo	placebo	saline ophthalmic solution

Primary Outcome Measures

Name	Time	Method
Healing time	12 weeks

Secondary Outcome Measures

Name	Time	Method
Adverse events	12 weeks