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A Multi Center, Open Label, Randomized, Two- Treatment, Single Dose, Crossover, Bioequivalence Study To Compare The Pharmacokinetics Of Marketed Product TobraDex® (Tobramycin And Dexamethasone Ophthalmic Ointment) To An Experimental Ophthalmic Sterile Ointment Containing Tobramycin 0.3% And Dexamethasone 0.1% W/W In Aqueous Humor In Patients Undergoing Indicated Cataract Surgery (TBO)
Each patient will be randomized to receive one dose of the test article in one eye and one dose of the reference formulations in the contralateral eye. One eye will be selected as the initial eye for cataract surgery and aqueous humor collection and hence will be dosed and operated on first. Followed by the second eye which will be dosed no early than a week followed by aqueous humor collection as per specified time points and no later than 35 days following the first eye again prior to the cataract surgery.
Details
| Lead sponsor | Semler Research Center Pvt. Ltd. |
|---|---|
| Phase | Phase 3 |
| Status | COMPLETED |
| Enrolment | 756 |
| Start date | 2013-11 |
| Completion | 2016-03 |
Conditions
- Bilateral Cataract
Interventions
- cataract surgery
Primary outcomes
- Concentration of dexamethasone in aqueous humor at different time points after administration of a single dose of each of the two drugs. — 30 min - 8 hours
A series of aqueous humor samples will be collected from each eye of each patient.