Safety and Efficacy Study of rEV131 in the Treatment of Ocular Inflammation After Cataract Surgery

Phase 2

• Conditions: Ocular Inflammation

• Registration Number: NCT00353964
• Lead Sponsor: Evolutec Group

Brief Summary

The purpose of this study is to evaluate the safety and effectiveness of three concentrations of rEV131, a new investigational anti-inflammatory agent, compared to placebo (an inactive substance) and an FDA approved anti-inflammatory agent in patients with ocular inflammation who have undergone cataract extraction with intra-ocular lens implantation.

Detailed Description

Not available

Study Timeline

• Status Verified: 2006-07
• Study First Submitted: 2006-07-17
• Study First Submitted QC: 2006-07-18
• Study First Posted: 2006-07-19
• Last Update Submitted: 2006-07-27
• Last Update Posted: 2006-07-28

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• be male or female who has undergone unilateral cataract extraction by phacoemulsification (PHACO) method with implantation of a posterior chamber intraocular lens

Exclusion Criteria

• have unstable glaucoma
• have an active bacterial and/or viral infection
• use any ocular or systemic anti-inflammatory agents within 1 week prior to enrollment and for the duration of the study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Trial Locations

Locations (1)

ORA Study Sites; 🇺🇸 North Andover, Massachusetts, United States