An interventional study of Systane and Refresh Tears in Dry Eye, sponsored by Alcon Research. Completed at 1 site in India. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-04-10.
Sponsored by Alcon Research (part of Alcon) · Not applicable, Interventional, and Treatment
This is a multi-site, randomized, investigator-masked study to evaluate the physical effects of Systane(R) versus Refresh Tears(R) in subjects with moderate to severe dry eye. It is a 6-week, perspective, randomized, active-controlled, investigator-masked, parallel group study.
1,325 studies on the registry are indexed under Dry Eye Syndromes; 193 are open to participants now.
This study's enrollment of 78 is above the median of 60 across 1,103 interventional studies indexed under Dry Eye Syndromes.
Browse Dry Eye Syndromes studies →Alcon Research is the lead sponsor of 624 studies on the registry; 9 are open to participants now.
Of its 111 completed or terminated interventional studies of FDA-regulated products, 100 (90%) have results posted.
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Exclusion Criteria:
Systane Lubricant Eye Drops
Other: Systane
Refresh Tears Lubricant Eye Drops
Other: Refresh Tears
Systane Lubricant Eye Drops (1-2 drops in each eye, four times per day)
Refresh Tears Lubricant Eye Drops (1-2 drops in each eye, four times per day)
To evaluate physical effects of Systane and Refresh Tears in subjects to moderate to severe dry eye.
This is a descriptive study in which changes from baseline in Tear Break up Time, corneal staining, and the Ocular Symptoms Questionnaire will be evaluated by treatment group at every visit. The outcome of the IDEEL questionnaire at Visit 3 will be compared to Visit 1 by treatment group; the results of treatment satisfaction questionnaires will be tabulated by treatment at Visit 3.
Time frame: Baseline to visit 3 (Day 42)
This study is completed, as verified in Jan 2012. You cannot join it, but the record below documents what was studied.
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