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Completed

NCT Number: NCT00600288

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

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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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

  • 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.

Treatment and study plan

Diquafosol tetrasodium ophthalmic solution, 2%

Drug

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

Non-preserved saline solution (Placebo)

Drug

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

Primary outcomes

  1. Change in fluorescein staining scores of the cornea

    Time frame: 6 weeks

Secondary outcomes

  1. Safety and Tolerability

    Time frame: 6 weeks

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 the Effects of Diquafosol Tetrasodium Ophthalmic Solution, 2% and Placebo in Subjects With Dry Eye Disease

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
Jan 24, 2008
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.

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