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| Name | Class |
|---|---|
| Genzum Life Sciences | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| tobramycin and dexamethasone ophthalmic test ointment | Experimental | The test drug (tobramycin is an aminoglycoside antibiotic and dexamethasone is a corticosteroid) will be administered in one eye before the cataract surgery. |
|
| TobraDex® ointment | Active Comparator | The reference drug (tobramycin is an aminoglycoside antibiotic and dexamethasone is a corticosteroid) will be administered in another eye before the cataract surgery. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cataract surgery | Drug | the patient will be dosed with the study drug into the "V" pocket is formed between the eye ball and the lower eyelid during cataract surgery. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Concentration of dexamethasone in aqueous humor at different time points after administration of a single dose of each of the two drugs. | A series of aqueous humor samples will be collected from each eye of each patient. | 30 min - 8 hours |
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| Measure | Description | Time Frame |
|---|---|---|
| Time at which maximum mean drug concentration (Tmax) is achieved, in aqueous humor after the administration of test and reference drugs. | 30 min - 8 hours | |
| AUC under the concentration-time curve from time-zero to the time t for test and reference drugs | 30 min - 8 hours |
Inclusion Criteria:
Exclusion Criteria:
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| Maximum drug concentration (Cmax) achieved, in aqueous humor after the administration of test and reference drugs. | 30 min - 8 hours |
| ID | Term |
|---|---|
| D002386 | Cataract |
| ID | Term |
|---|---|
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D002387 | Cataract Extraction |
| ID | Term |
|---|---|
| D054140 | Refractive Surgical Procedures |
| D013508 | Ophthalmologic Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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