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

Innovative Medical

Status and phase: Unknown; Phase 4

Conditions: Dry Eye Syndromes

Treatments: Drug: Refresh Tears; Drug: Altaire Gel forming solution

Study type: Interventional

Funder types: Industry

Identifiers

NCT01382810

Altaire2011

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 2 patient groups, including a placebo group

Altaire Gel forming solution

Active Comparator group

Treatment:

Drug: Altaire Gel forming solution

Refresh Tears

Placebo Comparator group

Treatment:

Drug: Refresh Tears