Study of the Effect of Diquafosol Tetrasodium Ophthalmic Solution, 2% Versus Placebo in Dry Eye Subjects (P08634)

A Multi-Center, Parallel-Group, Double-Masked, Randomized, Placebo-Controlled Study of the Effects of Diquafosol Tetrasodium Ophthalmic Solution, 2% and Placebo in Subjects With Dry Eye Disease

The purpose of this pilot study is to evaluate the effect of diquafosol tetrasodium Ophthalmic Solution, 2% in dry eye subjects.

Study Overview

• Status: Completed
• Conditions: Dry Eye Disease
• Intervention / Treatment: Drug: diquafosol tetrasodium Ophthalmic Solution, 2%; Drug: Non-preserved saline solution (Placebo)

• Study Type: Interventional
• Enrollment (Actual): 261
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Provide written informed consent prior to any study procedures being performed.
• Have a best corrected visual acuity (BCVAof +0.7 or better.
• Have a history of dry eye (keratoconjunctivitis sicca) in both eyes
• Have ongoing dry eye disease, in the same qualifying eye or both eyes.

Exclusion Criteria:

• Have previously had LASIK refractive surgery.
• Use of topical ophthalmic medications, preps, gels and lid scrubs during study.
• Have had penetrating intraocular surgery in the past 90 days.
• Have had other ocular surface surgery (e.g., refractive, pterygium) within the past year.
• Have a diagnosis of an on-going ocular infection, clinically significant blepharitis, lid margin inflammation, Stevens-Johnson syndrome or pemphigoid.
• Any serious ocular systemic disease or uncontrolled medical condition.
• Exposure to any investigational drug within 30 days of study start.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1	Drug: diquafosol tetrasodium Ophthalmic Solution, 2%; 1-2 drops administered in each eye 4 times a day for 6 weeks
Placebo Comparator: 2	Drug: Non-preserved saline solution (Placebo); 1-2 drops administered in each eye 4 times a day for 6 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in fluorescein staining scores of the cornea	6 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Safety and Tolerability	6 weeks

Collaborators and Investigators

• Sponsor: Merck Sharp & Dohme LLC
• Investigators: Study Director: Saiid Davari, Merck Sharp & Dohme LLC

Study record dates

Study Major Dates

• Study Start: January 1, 2008
• Primary Completion (Actual): May 1, 2008
• Study Completion (Actual): May 1, 2008

Study Registration Dates

• First Submitted: January 11, 2008
• First Submitted That Met QC Criteria: January 23, 2008
• First Posted (Estimate): January 24, 2008

Study Record Updates

• Last Update Posted (Estimate): January 9, 2015
• Last Update Submitted That Met QC Criteria: December 21, 2014
• Last Verified: December 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Lacrimal Apparatus Diseases; Keratoconjunctivitis; Conjunctivitis; Conjunctival Diseases; Keratitis; Corneal Diseases; Eye Diseases; Dry Eye Syndromes; Keratoconjunctivitis Sicca; Ophthalmic Solutions; Pharmaceutical Solutions
• Other Study ID Numbers: P08634; 03-111