Efficacy and Safety of IBI-10090 in Ocular Surgery Patients

September 17, 2014 updated by: ICON Bioscience Inc

A Multicenter, Randomized, Double-masked, Dose-ranging, Phase 2 Study to Evaluate the Efficacy and Safety of IBI-10090 for the Treatment of Inflammation Associated With Ocular Surgery

This study will test the efficacy and safety of IBI-10090 in the treatment of ocular inflammation after ocular surgery.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

172

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 Locations

  • United States
    • California
      • Hemet, California, United States, 92545
        • Inland Eye Specialists
      • Temecula, California, United States, 92591
        • California Eye Professionals

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

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients scheduled for unilateral cataract surgery

Exclusion Criteria:

  • Ocular, topical, or oral corticosteroids within 7 days of Day 0

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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Dose 1
Drug: IBI-10090
dexamethasone
Experimental: Dose 2
Drug: IBI-10090
dexamethasone
Experimental: Dose 3
Drug: IBI-10090
dexamethasone

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Anterior Chamber Cell Count at Day 8 Post-Treatment
Time Frame: 8 days post-treatment
This study will measure as its primary endpoint the anterior chamber cell count at Day 8 post-treatment. The proportion of patients with anterior chamber cell count = 0 at Day 8 for each dosage group will be compared.
8 days post-treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ICON Bioscience Inc

Investigators

  • Study Director: Wendy Murahashi, MD, Sponsor GmbH

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 Major Dates

Study Start

April 1, 2012

Primary Completion (Actual)

March 1, 2013

Study Completion (Actual)

March 1, 2013

Study Registration Dates

First Submitted

May 24, 2012

First Submitted That Met QC Criteria

May 25, 2012

First Posted (Estimate)

May 28, 2012

Study Record Updates

Last Update Posted (Estimate)

September 22, 2014

Last Update Submitted That Met QC Criteria

September 17, 2014

Last Verified

September 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C11-01

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.

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