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| ID | Type | Description | Link |
|---|---|---|---|
| P08646 |
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The objective of this study is to compare the safety and efficacy of azithromycin ophthalmic solution, 1% in dry eye subjects over a four week treatment period, using placebo as a comparison.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Azithromycin Ophthalmic Solution, 1% | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Azithromycin Ophthalmic Solution, 1% | Drug | 1 drop BID for the first 2 days and then 1 drop once a day for the remainder of the study (29 ± 1 days) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Tear Break-Up Time (TBUT) | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Corneal Staining | 4 weeks | |
| Tear Volume | 4 weeks | |
| Meibomian gland plugging |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Reza Haque, MD, PhD | Medical Monitor | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sall Research Medical Center, Inc. | Artesia | California | 90701 | United States | ||
| David Wirta, MD, Inc. |
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| Placebo | Drug | 1 drop BID for the first 2 days and then 1 drop once a day for the remainder of the study (29 ± 1 days) |
|
| 4 weeks |
| Subject-rated scores of dry eye symptoms | 4 weeks |
| Newport Beach |
| California |
| 92663 |
| United States |
| North Bay Eye Associates, Inc. | Petaluma | California | 94954 | United States |
| Kentucky Lions Eye Center | Louisville | Kentucky | 40207 | United States |
| Tauber Eye Center | Kansas City | Missouri | 64111 | United States |
| Ophthalmology Associates | St Louis | Missouri | 63131 | United States |
| Abrams Eye Center | Cleveland | Ohio | 44115 | United States |
| OSU - College of Optometry | Columbus | Ohio | 43210 | United States |
| Eye Clinics of South Texas | San Antonio | Texas | 78209 | United States |
| ID | Term |
|---|---|
| D015352 | Dry Eye Syndromes |
| ID | Term |
|---|---|
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
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