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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

62 participants

Study Classification

INTERVENTIONAL

Study Start Date

1999-09-30

Study Completion Date

2000-05-31

Brief Summary

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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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Detailed Description

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Conditions

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Dry Eye Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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diquafosol tetrasodium (INS365) ophthalmic solution

Intervention Type DRUG

Eligibility Criteria

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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

Eligible Sex

Accepts Healthy Volunteers

No