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OpenTrials
Completed

NCT Number: NCT00680108

A Study to Determine the Safety and Tolerability of Escalating Doses of INS365 Ophthalmic Solution

The purpose of this study is to evaluate the safety and tolerability of INS365 Ophthalmic Solution when applied topically as eyedrops in patients 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

Study type

Interventional

Phase

Phase 2

Who can participate

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

Inclusion criteria

  • Best corrected visual acuity 20/40 in each eye
  • 2 out 5 specified symptoms
  • Corneal fluorescein staining score greater than or equal to 3 out of 15

Exclusion criteria

  • Unable to stop concomitant medications
  • Have had intraocular surgery in previous 90 days
  • Have excluded systemic or ocular disease
  • Wear contact lenses and are not willing to remove them
  • Have intraocular pressure greater than 22 mg Hg

Treatment and study plan

diquafosol tetrasodium (INS365) Ophthalmic Solution

Drug

Primary outcomes

  1. Evaluation of adverse events

  2. Ocular symptomatology

  3. Visual acuity

  4. Biomicroscopy

  5. Ophthalmoscopy

Secondary outcomes

  1. Unanesthetized Schirmer test

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

A Double-Masked, Randomized, Placebo-Controlled, Rising-Dose Study of Multiple Ocular Instillations of INS365 Ophthalmic Solution in Patients With Mild to Moderate Dry Eye Disease.

Important dates

Study start
1999
Primary completion
2000
Study completion
2000
First posted
May 19, 2008
Registry last updated
Aug 27, 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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