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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 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
  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-Blind
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:

MedlinePlus related topics: Cataract
U.S. FDA Resources

Further study details as provided by Evolutec Group:

  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

No publications provided

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

Additional relevant MeSH terms:
Inflammation
Cataract
Pathologic Processes
Lens Diseases
Eye Diseases
 Sodium phosphate
Cathartics
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 19, 2013