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
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 April 17, 2014