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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
Information provided by:
Evolutec Group Identifier:
First received: July 17, 2006
Last updated: July 27, 2006
Last verified: July 2006
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:

Further study details as provided by Evolutec Group:


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
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, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00353964

United States, Massachusetts
ORA Study Sites
North Andover, Massachusetts, United States, 01845
Sponsors and Collaborators
Evolutec Group
Study Director: Wynne Weston-Davies, MD Evolutec Group
  More Information 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:
Capsule Opacification
Pathologic Processes
Lens Diseases
Eye Diseases processed this record on December 09, 2016