The Effects of Diquafosol Tetrasodium Ophthalmic Solution, 2% in Subjects With Dry Eye Disease (P08637)

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

490 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-01-31

Study Completion Date

2009-12-31

Brief Summary

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The purpose of this study is to confirm the safety and efficacy of diquafosol tetrasodium ophthalmic solution, 2% vs. placebo, in subjects with dry eye disease.

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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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Arm 2

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

One to two drops in each eye QID for 6 weeks

Arm 1

Group Type EXPERIMENTAL

Diquafosol tetrasodium ophthalmic solution, 2%

Intervention Type DRUG

One to two drops in each eye QID for 6 weeks

Interventions

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Diquafosol tetrasodium ophthalmic solution, 2%

One to two drops in each eye QID for 6 weeks

Intervention Type DRUG

Placebo

One to two drops in each eye QID for 6 weeks

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Have best corrected visual acuity in both eyes of at least +0.7 or better
* Central corneal staining of 3 on the NEI scale
* If female, are non-pregnant or non-lactating
* Have a history of dry eye disease in both eyes
* Have normal lid anatomy

Exclusion Criteria

* Unable to withhold the use of contact lenses during the study or 2 weeks prior to the study
* Have had ocular surface surgery within the past year
* Are considered legally blind in one eye
* Have a serious medical condition which could confound study assessments

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No