Conditions: Cataract
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 172
Healthy volunteers: no

Brief summary:
Study of T-PRED(TM) Compared to Pred Forte(R)

Detailed description:
This study was a multi-center, randomized, double-masked, bioequivalence study. A total of 172 participants undergoing bilateral cataract surgery were assigned investigational product to each eye according to a computer-generated randomization list for each of 2 study variables: treatment with T-PRED or Pred Forte in the first eye undergoing cataract extraction and the aqueous humor sampling time point.

The investigator determined which eye was clinically suited for the first operative procedure; treatment of this eye was randomized to either T-PRED or Pred Forte. The second eye received the other study treatment (RP if the first eye received T-PRED; T-PRED if the first eye received Pred Forte) at the time of the second cataract extraction.

Arms:
arm 1: Tobramycin prednisolone acetate combination arm 2: Prednisolone acetate

Interventions: intervention 1: T-Pred intervention 2: Pred Forte
Intervention descriptions: intervention 1: sterile ophthalmic solution intervention 2: sterile ophthalmic solution

Protocol document: