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

Evolutec Group

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Masking

DOUBLE

Conditions

Ocular Inflammation

Interventions

rEV131DRUG

Prenisolone sodium phosphate 1.0%DRUG

rEV131 vehicleDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

ORA Study Sites

North Andover, Massachusetts, United States

RECRUITING

Central Contacts

Susan French, ORA Clinical Research & Development Inc.

CONTACT

978-685-8900 sfrench@oraclinical.com

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.