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

Dry Eye Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00600288
• Other study ID #: P08634
• Secondary ID: 03-111
• Status: Completed
• Phase: Phase 3
• First received: January 11, 2008
• Last updated: December 21, 2014
• Start date: January 2008
• Est. completion date: May 2008

Study information

• Verified date: December 2014
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 261
• Est. completion date: May 2008
• Est. primary completion date: May 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dry Eye Disease
• Dry Eye Syndromes
• Eye Diseases
• Keratoconjunctivitis Sicca

Intervention

Drug:
• diquafosol tetrasodium Ophthalmic Solution, 2%
1-2 drops administered in each eye 4 times a day for 6 weeks
• Non-preserved saline solution (Placebo)
1-2 drops administered in each eye 4 times a day for 6 weeks

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in fluorescein staining scores of the cornea		6 weeks	No
Secondary	Safety and Tolerability		6 weeks	No