Skip to main content
OpenTrials
Completed

NCT Number: NCT00831662

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

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.

Completed

Looking for future studies?

Notify Me

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

  • 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

Treatment and study plan

Diquafosol tetrasodium ophthalmic solution, 2%

Drug

One to two drops in each eye QID for 6 weeks

Placebo

Drug

One to two drops in each eye QID for 6 weeks

Primary outcomes

  1. Proportion of subjects that achieve clearing of fluorescein staining of the central cornea (NEI scale). Subjects must have a score of 0 on the NEI scale at Week 6 to be considered responders.

    Time frame: 6 weeks

Secondary outcomes

  1. Proportion of subjects that achieve a 2-or-more-unit reduction of fluorescein staining of the central cornea (NEI scale)

    Time frame: 6 weeks

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Jan 29, 2009
Registry last updated
Jan 9, 2015

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.

Related clinical trials

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