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Phase IV, randomized, double-masked, parallel-group clinical trial comparing the ocular tolerability and steroid-induced intraocular pressure (IOP) effects of Zylet wth that of TobraDex in healthy volunteers, when either product was administered QID (at approximately 4-hour intervals) for 28 days.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Zylet | Experimental | Zylet (loteprednol etabonate and tobramycin) |
|
| Tobradex | Active Comparator | TobraDex (dexamethasone and tobramycin) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Loteprednol etabonate 0.5% and tobramycin 0.3% | Drug | ophthalmic suspension, four times daily during the day at roughly 4 hour intervals(1-2 drops per eye)for a total of 28 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Ocular comfort/tolerability | Day 1, 3, 8, 15, 22 and 29 | |
| Intraocular pressure measurements | Day 1, 3, 8,15, 22 and 29 |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of safety | Througout 28-day study |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Timothy L Comstock, DO | Bausch & Lomb Incorporated | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18577309 | Derived | Bartlett JD, Holland EJ, Usner DW, Paterno MR, Comstock TL. Tolerability of loteprednol/tobramycin versus dexamethasone/tobramycin in healthy volunteers: results of a 4-week, randomized, double-masked, parallel-group study. Curr Med Res Opin. 2008 Aug;24(8):2219-27. doi: 10.1185/03007990802231981. Epub 2008 Jun 23. |
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| ID | Term |
|---|---|
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000069559 | Loteprednol Etabonate |
| D003907 | Dexamethasone |
| D000078162 | Tobramycin, Dexamethasone Drug Combination |
| ID | Term |
|---|---|
| D000730 | Androstadienes |
| D000736 | Androstenes |
| D000731 | Androstanes |
| D013256 | Steroids |
| D000072473 |
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|
| Dexamethasone 0.1% and tobramycin 0.3% | Drug | ophthalmic suspension, four times daily during the day at roughly 4 hour intervals (1-2 drops/eye) for a total of 28 days. |
|
|
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013259 | Steroids, Fluorinated |
| D014031 | Tobramycin |
| D009328 | Nebramycin |
| D007612 | Kanamycin |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |