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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Systane | Experimental | Systane Lubricant Eye Drops |
|
| Refresh Tears | Experimental | Refresh Tears Lubricant Eye Drops |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Systane | Other | Systane Lubricant Eye Drops (1-2 drops in each eye, four times per day) |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline to visit 3 (Day 42) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vasan Eye Care Hospital | Saidāpet | Channai | 600 015 | India |
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| ID | Term |
|---|---|
| D015352 | Dry Eye Syndromes |
| ID | Term |
|---|---|
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
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| Refresh Tears |
| Other |
Refresh Tears Lubricant Eye Drops (1-2 drops in each eye, four times per day) |
|