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| ID | Type | Description | Link |
|---|---|---|---|
| P08644 |
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The primary objective of this study is to compare the duration of subject reported comfortable contact lens daily wear time in subjects with a history and current complaint of CLDE during a 29-day treatment period of azithromycin ophthalmic solution, 1%, compared to rewetting drops
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| azithromycin ophthalmic solution, 1% | Experimental |
| |
| rewetting drops | Experimental |
|
| 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 QD for the remainder of treatment period (29 ± 1 day) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Subject-reported comfortable contact lens daily wear time (hours/day) at Week 4 Endpoint | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Subject-reported comfortable contact lens daily wear time, excluding Week 4 Endpoint | 2 weeks | |
| Subject-reported duration of total contact lens daily wear | 4 weeks | |
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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 |
|---|---|---|---|---|---|---|
| The Ohio State University, College of Optometry | Columbus | Ohio | 43210 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22157392 | Derived | Nichols JJ, Bickle KM, Zink RC, Schiewe MD, Haque RM, Nichols KK. Safety and efficacy of topical azithromycin ophthalmic solution 1.0% in the treatment of contact lens-related dry eye. Eye Contact Lens. 2012 Mar;38(2):73-9. doi: 10.1097/ICL.0b013e31823ff229. |
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| Visine® for Contacts® | Drug | 1-2 drops QID for the treatment period (29 ± 1 day) |
|
| Subject-reported rating of overall eye dryness |
| 4 weeks |
| Contact Lens-Related Dry Eye Questionnaire | 4 weeks |
| Tear hyperosmolarity (mOsm) | 4 weeks |
| Habitual low-contrast visual acuity (LCVA) | 4 weeks |
| ID | Term |
|---|---|
| C005810 | tetrahydrozoline |
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