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Efficacy and Safety of IBI-10090 in Ocular Surgery Patients

This study has been completed.
Information provided by (Responsible Party):
ICON Bioscience Inc Identifier:
First received: May 24, 2012
Last updated: September 17, 2014
Last verified: September 2014
This study will test the efficacy and safety of IBI-10090 in the treatment of ocular inflammation after ocular surgery.

Condition Intervention Phase
Inflammation Associated With Cataract Surgery Drug: IBI-10090 Phase 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:

Further study details as provided by ICON Bioscience Inc:

Primary Outcome Measures:
  • 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.

Enrollment: 172
Study Start Date: April 2012
Study Completion Date: March 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Dose 1 Drug: IBI-10090
Experimental: Dose 2 Drug: IBI-10090
Experimental: Dose 3 Drug: IBI-10090


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

Inclusion Criteria:

  • Patients scheduled for unilateral cataract surgery

Exclusion Criteria:

  • Ocular, topical, or oral corticosteroids within 7 days of Day 0
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01606735

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
Study Director: Wendy Murahashi, MD Sponsor GmbH
  More Information

Responsible Party: ICON Bioscience Inc Identifier: NCT01606735     History of Changes
Other Study ID Numbers: C11-01
Study First Received: May 24, 2012
Results First Received: September 2, 2014
Last Updated: September 17, 2014

Keywords provided by ICON Bioscience Inc:
cataract surgery
ocular inflammation

Additional relevant MeSH terms:
Pathologic Processes
Lens Diseases
Eye Diseases processed this record on September 21, 2017