Study of T-PRED(TM) Compared to Pred Forte(R) II

Bausch + Lomb

Status and phase: Completed; Phase 3

Conditions: Cataract

Treatments: Drug: T-Pred; Drug: Pred Forte

Study type: Interventional

Funder types: Industry

Identifiers

NCT00854061

CL-PKT-0415083-P

Details and patient eligibility

About

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

Full 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.

Enrollment: 172 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 18 years of age or older

Exclusion criteria

• No active or adverse disease

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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172 participants in 2 patient groups

T-Pred

Experimental group

Description:

Tobramycin prednisolone acetate combination

Treatment:

Drug: T-Pred

Pred Forte

Active Comparator group

Description:

Prednisolone acetate

Treatment:

Drug: Pred Forte