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

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 3

Conditions: Dry Eye Disease

Treatments: Drug: Non-preserved saline solution (Placebo); Drug: diquafosol tetrasodium Ophthalmic Solution, 2%

Study type: Interventional

Funder types: Industry

Identifiers

NCT00600288

03-111

P08634

Details and patient eligibility

About

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

Enrollment: 261 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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261 participants in 2 patient groups, including a placebo group

1

Experimental group

Treatment:

Drug: diquafosol tetrasodium Ophthalmic Solution, 2%

2

Placebo Comparator group

Treatment:

Drug: Non-preserved saline solution (Placebo)