NCT00854061

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 172 (actual)
• Sponsor: Bausch & Lomb Incorporated · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cataract

Interventions

Type	Name	Description
DRUG	T-Pred	sterile ophthalmic solution
DRUG	Pred Forte	sterile ophthalmic solution

Timeline

• Start date: 2009-02-01
• Primary completion: 2009-08-01
• Completion: 2009-08-01
• First posted: 2009-03-02
• Last updated: 2020-10-20
• Results posted: 2020-10-20

Locations

1 site across 1 country: United States