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

Status Completed

Clinical Trial Summary

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

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Cataract

Clinical Trial Details

NCT number	NCT00854061
Study type	Interventional
Source	Bausch & Lomb Incorporated
Contact
Status	Completed
Phase	Phase 3
Start date	February 2009
Completion date	August 2009

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