Recruiting
Phase 2

rEV131

Sponsor:

Evolutec Group

Code:

NCT00353964

Conditions

Ocular Inflammation

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

rEV131

Prenisolone sodium phosphate 1.0%

rEV131 vehicle

Study Details

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.

Conditions

Ocular Inflammation

Study ID

NCT00353964

Status verified date

Jul, 2006

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Allocation

Randomized

Intervention Model

Parallel Assignment

Interventions and Outcome Measures

Interventions

rEV131

Prenisolone sodium phosphate 1.0%

rEV131 vehicle

Central Contacts and Locations

Central contacts

Susan French, ORA Clinical Research & Development Inc.

978-685-8900sfrench@oraclinical.com

Locations

ORA Study Sites

Recruiting

North Andover, Massachusetts, United States, 01845

Contacts

ORA Site Support Center

866-393-3767

More Information

Sponsor

Evolutec Group

Last update posted

Jul 28, 2006

Last verified

Jul, 2006

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Evolutec Group on 2006-07-28.