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

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.
 
ClinicalTrials.gov Identifier: NCT00353964
Recruitment Status : Unknown
Verified July 2006 by Evolutec Group.
Recruitment status was:  Recruiting
First Posted : July 19, 2006
Last Update Posted : July 28, 2006
Sponsor:
Information provided by:
Evolutec Group

Study Description
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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.

Condition or disease Intervention/treatment Phase
Ocular Inflammation Drug: rEV131 Drug: Prenisolone sodium phosphate 1.0% Drug: rEV131 vehicle Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
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 the National Library of Medicine

MedlinePlus related topics: Cataract

Arms and Interventions
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Outcome Measures
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Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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
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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
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Contact: Susan French, ORA Clinical Research & Development Inc. 978-685-8900 ext 242 sfrench@oraclinical.com

Locations
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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
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Study Director: Wynne Weston-Davies, MD Evolutec Group
More Information
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ClinicalTrials.gov Identifier: NCT00353964    
Other Study ID Numbers: EVOL-PRO-06-024
First Posted: July 19, 2006    Key Record Dates
Last Update Posted: July 28, 2006
Last Verified: July 2006
Additional relevant MeSH terms:
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Cataract
Capsule Opacification
Inflammation
 Pathologic Processes
Lens Diseases
Eye Diseases