Efficacy and Safety of IBI-10090 in Ocular Surgery Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
ICON Bioscience Inc
ClinicalTrials.gov Identifier:
NCT01606735
First received: May 24, 2012
Last updated: July 15, 2013
Last verified: June 2013
  Purpose

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


Condition Intervention Phase
Ocular Surgery Inflammation
Drug: IBI-10090
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

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 ] [ Designated as safety issue: Yes ]
    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
dexamethasone
Experimental: Dose 2 Drug: IBI-10090
dexamethasone
Experimental: Dose 3 Drug: IBI-10090
dexamethasone

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
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
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 ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: ICON Bioscience Inc
ClinicalTrials.gov Identifier: NCT01606735     History of Changes
Other Study ID Numbers: C11-01
Study First Received: May 24, 2012
Last Updated: July 15, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by ICON Bioscience Inc:
cataract surgery
ocular inflammation

Additional relevant MeSH terms:
Inflammation
Pathologic Processes

ClinicalTrials.gov processed this record on August 28, 2014