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

The recruitment status of this study is unknown because the information has not been verified recently.

Verified July 2006 by Evolutec Group.
Recruitment status was Recruiting

Sponsor:

Information provided by:

Evolutec Group

ClinicalTrials.gov Identifier:

NCT00353964

First received: July 17, 2006

Last updated: July 27, 2006

Last verified: July 2006

History of Changes

Tracking Information

First Received Date ^ICMJE

July 17, 2006

Last Updated Date

July 27, 2006

Start Date ^ICMJE

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT00353964 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Current Other Outcome Measures ^ICMJE

Original Other Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double-Blind

Condition ^ICMJE

Ocular Inflammation

Intervention ^ICMJE

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

Study Arm (s)

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Enrollment ^ICMJE

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Susan French, ORA Clinical Research & Development Inc.

978-685-8900 ext 242

sfrench@oraclinical.com

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00353964

Other Study ID Numbers ^ICMJE

EVOL-PRO-06-024

Has Data Monitoring Committee

Responsible Party

Study Sponsor ^ICMJE

Evolutec Group

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Wynne Weston-Davies, MD

Evolutec Group

Information Provided By

Evolutec Group

Verification Date

July 2006

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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