Altaire Gel Forming Solution Versus Refresh Tears for the Treatment of Dry Eye Signs and Symptoms

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

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-03-31

Study Completion Date

2012-10-31

Brief Summary

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The purpose of this study is to evaluate and compare the effects of Altaire Gel forming solution and Refresh Tears in mild-moderate dry eye patients.

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Detailed Description

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Conditions

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Dry Eye Syndromes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Altaire Gel forming solution

Group Type ACTIVE_COMPARATOR

Altaire Gel forming solution

Intervention Type DRUG

Three times a day for two months

Refresh Tears

Group Type PLACEBO_COMPARATOR

Refresh Tears

Intervention Type DRUG

Three times a day for two months

Interventions

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Altaire Gel forming solution

Three times a day for two months

Intervention Type DRUG

Refresh Tears

Three times a day for two months

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients 18 years or older.
* Males or females.
* Patient reported dry eye symptoms (episodic, annoying, activity limiting).
* Physician assessment of mild-moderate dry eye.
* Patient willing to instill drops TID and complete entire length of protocol.
* TBUT \_\< 10 seconds.
* At least Grade 6 Corneal Staining.

Exclusion Criteria

* Current topical cyclosporine use (Restasis)
* Current Refresh use.
* Refractive surgery within the last 6 months.
* Oral or topical corticosteroid use.
* Severe dry eye patients by physician assessment.
* Current active blepharitis.
* Oral doxycycline use.
* Oral antihistamine use.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes