NCT00353964

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 17, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 19, 2006

Completed
Last Updated

July 28, 2006

Status Verified

July 1, 2006

First QC Date

July 17, 2006

Last Update Submit

July 27, 2006

Conditions

Ocular Inflammation

Interventions

rEV131DRUG
Prenisolone sodium phosphate 1.0%DRUG
rEV131 vehicleDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • be male or female who has undergone unilateral cataract extraction by phacoemulsification (PHACO) method with implantation of a posterior chamber intraocular lens

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ORA Study Sites

North Andover, Massachusetts, 01845, United States

RECRUITING

MeSH Terms

Interventions

rEV131 protein, tick

Study Officials

  • Wynne Weston-Davies, MD

    Evolutec Group

    STUDY DIRECTOR

Central Study Contacts

Susan French, ORA Clinical Research & Development Inc.

CONTACT

978-685-8900sfrench@oraclinical.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

July 17, 2006

First Posted

July 19, 2006

Last Updated

July 28, 2006

Record last verified: 2006-07

Locations

US(1)