Safety and Efficacy Study of rEV131 in the Treatment of O... | NCT00353964

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

NCT00353964

Sponsor

Evolutec Group

Status

Unknown status

Last Update Posted

Jul 28, 2006Estimated

Enrollment

Not provided

Phase

Phase 2

Conditions

Ocular Inflammation

Interventions

rEV131
Prenisolone sodium phosphate 1.0%
rEV131 vehicle

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2006

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Not provided

Start Date

Not provided

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Jul 17, 2006

First Submission Date that Met QC Criteria

Jul 18, 2006

First Posted Date

Jul 19, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 27, 2006

Last Update Posted Date

Jul 28, 2006Estimated

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Susan French, ORA Clinical Research & Development Inc.	Contact	978-685-8900	242	sfrench@oraclinical.com

Overall Officials

Name	Affiliation	Role
Wynne Weston-Davies, MD	Evolutec Group	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
ORA Study Sites	Recruiting	North Andover	Massachusetts	01845	United States

Name	Type	Description	Arm Group Labels	Other Names
rEV131	Drug
Prenisolone sodium phosphate 1.0%	Drug
rEV131 vehicle	Drug