Overview

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

Status:
Unknown status
Trial end date:
1969-12-31
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Evolutec Group
Criteria
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.