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The objective of this study is to evaluate the safety and efficacy of Zylet vs. Tobradex in the treatment of ocular inflammation associated with blepharokeratoconjunctivitis
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Zylet | Experimental | Loteprednol etabonate and tobramycin ophthalmic suspension, 0.5%/0.3% (Zylet) |
|
| Tobradex | Active Comparator | Tobradex (tobramycin and dexamethasone ophthalmic suspension, 0.3%/0.1%), US marketed product (Alcon) from commercial lots. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Loteprednol etabonate and tobramycin ophthalmic suspension | Drug | Subjects will self-administer the study drug in the affected eye(s) 4 times a day (QID) for 14 days. |
|
| Measure | Description | Time Frame |
|---|---|---|
| The primary efficacy endpoint for this study is the change from baseline to Day 15 in the signs and symptoms composite score | 15 days |
| Measure | Description | Time Frame |
|---|---|---|
| The distribution of Investigator global assessment at each visit. | Visit 2, 3 & 4 | |
| The percentage of eyes that were considered improved or cured at each visit based on the Investigator global assessment. | Visit 2, 3 & 4 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Timothy Comstock, OD | Bausch & Lomb Incorporated | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cornerstone Eye Care | High Point | North Carolina | 27262 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18062846 | Derived | White EM, Macy JI, Bateman KM, Comstock TL. Comparison of the safety and efficacy of loteprednol 0.5%/tobramycin 0.3% with dexamethasone 0.1%/tobramycin 0.3% in the treatment of blepharokeratoconjunctivitis. Curr Med Res Opin. 2008 Jan;24(1):287-96. doi: 10.1185/030079908x253898. |
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| ID | Term |
|---|---|
| D000069559 | Loteprednol Etabonate |
| D014031 | Tobramycin |
| ID | Term |
|---|---|
| D000730 | Androstadienes |
| D000736 | Androstenes |
| D000731 | Androstanes |
| D013256 | Steroids |
| D000072473 |
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| Tobramycin and dexamethasone ophthalmic suspension | Drug | Subjects will self-administer the study drug in the affected eye(s) 4 times a day (QID) for 14 days. |
|
| The change from baseline to Day 7 (Visit 3) and to Day 3 (Visit 2) in the signs and symptoms composite score. | Visit 2 & 3 |
| The change from baseline to each visit in the signs composite score and the symptoms composite score. | Visit 1, 2, 3 & 4 |
| The change from baseline to each visit in the Blepharitis signs composite score, the conjunctivitis signs composite score, and the Keratitis signs composite score. | Visit 1, 2, 3 & 4 |
| The change from baseline to each visit in individual signs and symptoms. | Visit 1, 2, 3 & 4 |
| VA, Biomicroscopy, and IOP assessments at each visit | Visit 1, 2, 3 & 4 |
| Adverse Events | Visit 1, 2, 3 & 4 |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D009328 | Nebramycin |
| D007612 | Kanamycin |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |