Altaire Gel Forming Solution Versus Refresh Tears for the Treatment of Dry Eye Signs and Symptoms
Phase 4
- Conditions
- Dry Eye Syndromes
- Interventions
- Drug: Altaire Gel forming solution
- Registration Number
- NCT01382810
- Lead Sponsor
- Innovative Medical
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 100
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Altaire Gel forming solution Altaire Gel forming solution - Refresh Tears Refresh Tears -
- Primary Outcome Measures
Name Time Method TBUT 2 months Test performed that measures how long the tears take to break up
Conjunctival and Corneal staining 2 months Dye that will be placed inside the eye to evaluate the surface of the ey
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (2)
Koch Eye Associates
🇺🇸Warwick, Rhode Island, United States
Jackson Eye, SC
🇺🇸Lake Villa, Illinois, United States