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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Masking
NONE
Enrollment
756
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.
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.
Time frame: 30 min - 8 hours
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