Study of INS365 Ophthalmic Solution in Subjects With 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

PHASE3

Total Enrollment

500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-03-31

Study Completion Date

2001-12-31

Brief Summary

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The purpose of this trial is to compare the effectiveness and safety of INS365 Ophthalmic Solution with placebo when applied topically in subjects with dry eye disease.

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 in both eyes of at least +0.7
* six-month documented history of dry eye disease
* at least mild severity in 2 of the 4 dry eye symptoms
* unanesthetized Schirmer score of less than or equal to 7mm
* corneal fluorescein staining of greater than or equal to 4 (out of 15)

Exclusion Criteria

* nasally stimulated Schirmer score of less than 3mm in subjects with an initial Schirmer score of 0mm
* ongoing contact lens wear
* current topical ophthalmic medication use

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Amy Schaberg, BSN

Role: STUDY_DIRECTOR

Countries

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United States

References

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Tauber J, Davitt WF, Bokosky JE, Nichols KK, Yerxa BR, Schaberg AE, LaVange LM, Mills-Wilson MC, Kellerman DJ. Double-masked, placebo-controlled safety and efficacy trial of diquafosol tetrasodium (INS365) ophthalmic solution for the treatment of dry eye. Cornea. 2004 Nov;23(8):784-92. doi: 10.1097/01.ico.0000133993.14768.a9.

Reference Type RESULT

PMID: 15502479 (View on PubMed)

Other Identifiers

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03-105

Identifier Type: -

Identifier Source: org_study_id