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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified July 2006 by Evolutec Group.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00353964
First Posted: July 19, 2006
Last Update Posted: July 28, 2006
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Evolutec Group
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
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

Resource links provided by NLM:


Further study details as provided by Evolutec Group:

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00353964     History of Changes
Other Study ID Numbers: EVOL-PRO-06-024
First Submitted: July 17, 2006
First Posted: July 19, 2006
Last Update Posted: July 28, 2006
Last Verified: July 2006

Additional relevant MeSH terms:
Inflammation
Cataract
Capsule Opacification
Pathologic Processes
Lens Diseases
Eye Diseases