A Study of INS365 Ophthalmic Solution in Patients With Moderate to Severe Dry Eye Disease

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

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2000-01-31

Study Completion Date

2000-07-31

Brief Summary

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To evaluate the efficacy and safety of INS365 Ophthalmic Solution when applied topically in patients with moderate to severe 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 of at least +0.7 ETDRS
* Six month history of dry eye disease
* Mild severity in two out of five symptoms
* Unanesthetized Schirmer score of less than or equal to 7mm
* Corneal fluorescein staining greater than or equal to 4 out of 15 or lissamine green conjunctival staining of greater than or equal to 5 out of 18

Exclusion Criteria

* Nasal stimulated Schirmer score of less than 3mm
* Have ongoing ocular infection
* Have congenitally absent meibomian or lacrimal glands
* Have had punctal occlusion within a specified time prior to study
* Wear contact lens and refuse to remove them
* Have other excluded eye conditions.

Eligible Sex

Accepts Healthy Volunteers

No