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

• Sponsor: Merck Sharp & Dohme LLC (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00600288
• Collaborator: (none)
• Enrollment: 261
• Arms: 2
• Duration (Months): 4

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Dry Eye Disease	Drug: diquafosol tetrasodium Ophthalmic Solution, 2%; Drug: Non-preserved saline solution (Placebo)	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 261 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: 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
• Study Start Date: Jan 1, 2008
• Actual Primary Completion Date: May 1, 2008
• Actual Study Completion Date: May 1, 2008

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Change in fluorescein staining scores of the cornea [6 weeks]

Secondary Outcome Measures

1. Safety and Tolerability [6 weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Merck Sharp & Dohme LLC

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Merck Sharp & Dohme LLC
• ClinicalTrials.gov Identifier: NCT00600288
• Other Study ID Numbers: P08634; 03-111
• First Posted: Jan 24, 2008
• Last Update Posted: Jan 9, 2015
• Last Verified: Dec 1, 2014

• Additional relevant MeSH terms: Dry Eye Syndromes; Keratoconjunctivitis Sicca; Eye Diseases; Pharmaceutical Solutions; Ophthalmic Solutions

Study Results

No Results Posted as of Jan 9, 2015