- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00353964
Safety and Efficacy Study of rEV131 in the Treatment of Ocular Inflammation After Cataract Surgery
July 27, 2006 updated by: Evolutec Group
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
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Susan French, ORA Clinical Research & Development Inc.
- Phone Number: 242 978-685-8900
- Email: sfrench@oraclinical.com
Study Locations
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Massachusetts
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North Andover, Massachusetts, United States, 01845
- Recruiting
- ORA Study Sites
-
Contact:
- ORA Site Support Center
- Phone Number: 866-393-3767
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Wynne Weston-Davies, MD, Evolutec Group
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Registration Dates
First Submitted
July 17, 2006
First Submitted That Met QC Criteria
July 18, 2006
First Posted (Estimate)
July 19, 2006
Study Record Updates
Last Update Posted (Estimate)
July 28, 2006
Last Update Submitted That Met QC Criteria
July 27, 2006
Last Verified
July 1, 2006
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- EVOL-PRO-06-024
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Ocular Inflammation
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AgnesDirection Générale de l'Offre de Soins; Laboratoires TheaRecruitingOcular Inflammation | Ocular ProsthesesFrance
-
Campus Bio-Medico UniversityCompletedOcular Inflammation | Ocular Surface DiseaseItaly
-
Laboratorios Sophia S.A de C.V.CompletedOcular Inflammation | Ocular Pain | Pterygium | Post-surgical InflammationMexico
-
Sligo General HospitalCompletedOcular InflammationIreland
-
Surface Ophthalmics, Inc.CompletedPost-surgical Ocular Inflammation | Post-surgical Ocular PainUnited States
-
Kerry Assil, MDUnknownPost-Surgical Ocular Pain | Post-Surgical Ocular InflammationUnited States
-
Tarsier PharmaCompletedPost Surgical Ocular InflammationUnited States
-
University of TriesteCompleted
-
Federal University of São PauloAllerganCompletedOcular Infection and InflammationBrazil
-
Alcon ResearchCompletedOcular Inflammation Associated With BlepharaconjunctivitisUnited States
Clinical Trials on rEV131
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Evolutec GroupUnknown