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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

261 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-01-31

Study Completion Date

2008-05-31

Brief Summary

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

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Detailed Description

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Conditions

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Dry Eye Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

Group Type EXPERIMENTAL

diquafosol tetrasodium Ophthalmic Solution, 2%

Intervention Type DRUG

1-2 drops administered in each eye 4 times a day for 6 weeks

2

Group Type PLACEBO_COMPARATOR

Non-preserved saline solution (Placebo)

Intervention Type DRUG

1-2 drops administered in each eye 4 times a day for 6 weeks

Interventions

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diquafosol tetrasodium Ophthalmic Solution, 2%

1-2 drops administered in each eye 4 times a day for 6 weeks

Intervention Type DRUG

Non-preserved saline solution (Placebo)

1-2 drops administered in each eye 4 times a day for 6 weeks

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No