Altaire Gel Forming Solution Versus Refresh Tears for the Treatment of Dry Eye Signs and Symptoms
A Randomized Masked Evaluation of Altaire Gel Forming Solution Versus Refresh Tears for the Treatment of Dry Eye Signs and Symptoms
1 other identifier
interventional
100
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Mar 2011
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2011
CompletedFirst Submitted
Initial submission to the registry
June 24, 2011
CompletedFirst Posted
Study publicly available on registry
June 27, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2012
CompletedJune 14, 2012
June 1, 2012
1.6 years
June 24, 2011
June 13, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
TBUT
Test performed that measures how long the tears take to break up
2 months
Conjunctival and Corneal staining
Dye that will be placed inside the eye to evaluate the surface of the ey
2 months
Study Arms (2)
Altaire Gel forming solution
ACTIVE COMPARATORRefresh Tears
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Jackson Eye, SC
Lake Villa, Illinois, United States
Koch Eye Associates
Warwick, Rhode Island, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
June 24, 2011
First Posted
June 27, 2011
Study Start
March 1, 2011
Primary Completion
October 1, 2012
Study Completion
October 1, 2012
Last Updated
June 14, 2012
Record last verified: 2012-06