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Clinical Trials/NCT00680108
NCT00680108
Completed
Phase 2

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.

Merck Sharp & Dohme LLC0 sites62 target enrollmentSeptember 1999
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ConditionsDry Eye Disease
Drugsdiquafosol tetrasodium (INS365) ophthalmic solution

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Dry Eye Disease
Sponsor
Merck Sharp & Dohme LLC
Enrollment
62
Primary Endpoint
Evaluation of adverse events
Status
Completed
Last Updated
10 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
September 1999
End Date
May 2000
Last Updated
10 years ago
Study Type
Interventional
Study Design
Parallel

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Evaluation of adverse events

Ocular symptomatology

Visual acuity

Biomicroscopy

Ophthalmoscopy

Secondary Outcomes

  • Unanesthetized Schirmer test

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