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NCT00353964 Clinical Trial

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

Ocular Inflammation Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT00353964
Other study ID # EVOL-PRO-06-024
Secondary ID
Status Recruiting
Phase Phase 2
First received July 17, 2006
Last updated July 27, 2006

Study information
Verified date July 2006
Source Evolutec Group
Contact Susan French, ORA Clinical Research & Development Inc.
Phone 978-685-8900
Email sfrench@oraclinical.com
Is FDA regulated No
Health authority United States: Food and Drug AdministrationUnited States: Institutional Review Board
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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, Masking: Double-Blind

Related Conditions & MeSH terms

Intervention

Drug:
• rEV131

• Prenisolone sodium phosphate 1.0%

• rEV131 vehicle

Locations
Country Name City State
United States ORA Study Sites North Andover Massachusetts

Sponsors (1)
Lead Sponsor Collaborator
Evolutec Group

Country where clinical trial is conducted

United States, 

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