Study of Diquafosol Tetrasodium Ophthalmic Solution in Subjects With Dry Eye Disease

The purpose of this trial is to assess the effectiveness and safety of 2% diquafosol tetrasodium ophthalmic solution versus placebo following 6 weeks of treatment in subjects with mild to moderate dry eye disease.

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Key information

Conditions

Dry Eye Disease Dry Eye Syndromes Eye Diseases Lacrimal Apparatus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

best corrected visual acuity in both eyes of at least +0.7
six-month documented history of dry eye disease
as least mild severity in 1 of the 5 dry eye symptoms
corneal fluorescein staining of greater than or equal to 3 and less than or equal to 6 (out of 15)

Exclusion criteria

permanent conjunctival goblet cell loss or scarring conditions
ongoing contact lens wear
current topical ophthalmic medication use

Treatment and study plan

Diquafosol tetrasodium ophthalmic solution, 2%

Drug

Primary outcomes

Change in dry eye testing measures

Secondary outcomes

Change in dry eye testing measures and symptoms

Interested in participating?

Completed

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Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

A Multi-Center, Parallel Group, Double-Masked, Randomized, Placebo-Controlled Study of Multiple Ocular Instillations of Diquafosol Tetrasodium Ophthalmic Solution, 2% in Subjects With Dry Eye Disease

Important dates

Study start: 2004
Primary completion: 2004
Study completion: 2004
First posted: Nov 27, 2006
Registry last updated: Feb 22, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed