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The purpose of this study is to determine whether ecabet ophthalmic solution is an effective treatment for dry eye syndrome
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ecabet 2.83% | Experimental | Ecabet ophthalmic solution One drop in study eye 4 times daily for 90 days. |
|
| Ecabet 3.70% | Experimental | Ecabet ophthalmic solution One drop in study eye 4 times daily for 90 days. |
|
| Vehicle | Placebo Comparator | One drop of vehicle in study eye 4 times daily for 90 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ecabet 2.83% | Drug |
| ||
| Ecabet 3.70% |
| Measure | Description | Time Frame |
|---|---|---|
| Ocular discomfort | Group mean change in ocular discomfort score from pre-Cataract extraction (CAE) to post-CAE | Day 91 |
| Tear Film Break-up Time (TFBUT) | Group mean change in time to tear break-up from pre-CAE to post-CAE. | Day 91 |
| Blink Rate | Group mean change in blinks/min from pre-CAE to post-CAE. | Day 91 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tim McNamara, PharmD | ISTA Pharmaceuticals, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Central Maine Eye Care | Lewiston | Maine | 04240 | United States | ||
| Andover Eye Associates |
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| ID | Term |
|---|---|
| D015352 | Dry Eye Syndromes |
| ID | Term |
|---|---|
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
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|
| Vehicle | Drug |
|
| Andover |
| Massachusetts |
| 01840 |
| United States |
| Eyesight Ophthalmic Services, PA | Dover | New Hampshire | 03820 | United States |