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Efficacy and Safety of IBI-10090 in Ocular Surgery Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01606735
Recruitment Status : Completed
First Posted : May 28, 2012
Results First Posted : September 22, 2014
Last Update Posted : September 22, 2014
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
This study will test the efficacy and safety of IBI-10090 in the treatment of ocular inflammation after ocular surgery.

Condition or disease Intervention/treatment Phase
Inflammation Associated With Cataract Surgery Drug: IBI-10090 Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 172 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : April 2012
Primary Completion Date : March 2013
Study Completion Date : March 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract Eye Care
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Dose 1 Drug: IBI-10090
dexamethasone
Experimental: Dose 2 Drug: IBI-10090
dexamethasone
Experimental: Dose 3 Drug: IBI-10090
dexamethasone


Outcome Measures

Primary Outcome Measures :
  1. 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.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients scheduled for unilateral cataract surgery

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01606735


Locations
United States, California
Inland Eye Specialists
Hemet, California, United States, 92545
California Eye Professionals
Temecula, California, United States, 92591
Sponsors and Collaborators
ICON Bioscience Inc
Investigators
Study Director: Wendy Murahashi, MD Sponsor GmbH
More Information

Responsible Party: ICON Bioscience Inc
ClinicalTrials.gov Identifier: NCT01606735     History of Changes
Other Study ID Numbers: C11-01
First Posted: May 28, 2012    Key Record Dates
Results First Posted: September 22, 2014
Last Update Posted: September 22, 2014
Last Verified: September 2014

Keywords provided by ICON Bioscience Inc:
cataract surgery
ocular inflammation

Additional relevant MeSH terms:
Inflammation
Cataract
Pathologic Processes
Lens Diseases
Eye Diseases