Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00695435 | Tobramycin Tear Concentrations | PHASE1 | COMPLETED | 21 | — | — | Jun 1, 2008 | - | Mar 2, 2010 | 1 | United States |
Tear samples were collected to measure tobramycin concentrations at 2, 4, 6, 12, and 18 minutes post-drop instillation in each subject's right eye for each treatment period.
| Arm | Type | Description |
|---|---|---|
| Tobramycin 0.3% / Dexamethasone 0.05% Ophthalmic Suspension | EXPERIMENTAL | Tobramycin 0.3% / Dexamethasone 0.05% Ophthalmic Suspension |
| TOBREX® Ophthalmic Solution | ACTIVE_COMPARATOR | TOBREX® Ophthalmic Solution |
| TOBRADEX® Ophthalmic Suspension | ACTIVE_COMPARATOR | TOBRADEX® Ophthalmic Suspension |
| Name | Type | Description |
|---|---|---|
| TOBRADEX Ophthalmic Suspension | DRUG | TOBRADEX Ophthalmic Suspension 1 drop each eye at baseline |
| Tobramycin 0.3% / Dexamethasone 0.05% Ophthalmic Suspension | DRUG | Tobramycin 0.3% / Dexamethasone 0.05% Ophthalmic Suspension 1 drop each eye at baseline |
| TOBREX Ophthalmic Solution | DRUG | TOBREX Ophthalmic Solution 1 drop each eye at baseline |
Inclusion: * Visual Acuity (VA) of 0.6 logMAR or better * Tear meniscus height of ≥ 0.3mm at Visit 1. * No concomitant topical ocular medications, including artificial tears, during the study period Exclusion * ocular hypertension, iritis or uveitis, glaucoma * ocular surgery, intraocular surgery...