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

Evolutec Group

Status and phase: Unknown; Phase 2

Conditions: Ocular Inflammation

Treatments: Drug: Prenisolone sodium phosphate 1.0%; Drug: rEV131; Drug: rEV131 vehicle

Study type: Interventional

Funder types: Industry

Identifiers

NCT00353964

EVOL-PRO-06-024

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.