Safety and Efficacy Study of rEV131 in the Treatment of Ocular Inflammation After Cataract Surgery - Full Text View

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

This study is currently recruiting participants.
Verified by Evolutec Group, July 2006

Sponsored by:	Evolutec Group
Information provided by:	Evolutec Group
ClinicalTrials.gov Identifier:	NCT00353964

Purpose

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.

Condition	Intervention	Phase
Ocular Inflammation	Drug: rEV131 Drug: Prenisolone sodium phosphate 1.0% Drug: rEV131 vehicle	Phase II

MedlinePlus related topics:

Cataract

Drug Information available for:

Sodium phosphate, dibasic

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Randomized, Double-Blind, Active Control, Parallel Assignment

Official Title:	A Multi-Center, Randomized, Double Masked, Placebo and Active Controlled, Parallel-Group Study Evaluating the Safety and Efficacy of rEV131 2.5 Mg/mL, rEV131 1.25 Mg/mL, rEV131 0.625 Mg/mL, for the Treatment of Ocular Inflammation After Cataract Surgery

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00353964

Contacts


Contact: Susan French, ORA Clinical Research & Development Inc.	978-685-8900 ext 242	sfrench@oraclinical.com

Locations


United States, Massachusetts
	ORA Study Sites	Recruiting
	North Andover, Massachusetts, United States, 01845
	Contact: ORA Site Support Center 866-393-3767

Sponsors and Collaborators

Evolutec Group

Investigators


Study Director:	Wynne Weston-Davies, MD	Evolutec Group

More Information

Study ID Numbers:	EVOL-PRO-06-024
First Received:	July 17, 2006
Last Updated:	July 27, 2006
ClinicalTrials.gov Identifier:	NCT00353964
Health Authority:	United States: Food and Drug Administration; United States: Institutional Review Board

Study placed in the following topic categories:

Sodium phosphate

Cataract

Inflammation

Additional relevant MeSH terms:

Pathologic Processes

Therapeutic Uses

Gastrointestinal Agents

Cathartics

Pharmacologic Actions

ClinicalTrials.gov processed this record on November 03, 2008