Efficacy and Safety Study of IBI-10090 in Cataract Surgery Patients

This study has been terminated.
(Study C11-01 started)
Sponsor:
Information provided by (Responsible Party):
ICON Bioscience Inc
ClinicalTrials.gov Identifier:
NCT01214174
First received: September 21, 2010
Last updated: September 16, 2013
Last verified: September 2013
  Purpose

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


Condition Intervention Phase
Ocular 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, 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 in Treating Inflammation in Cataract Surgery Patients

Resource links provided by NLM:


Further study details as provided by ICON Bioscience Inc:

Primary Outcome Measures:
  • Proportion of Patients With Anterior Chamber Cell Clearing at Day 8 Post-Treatment [ Time Frame: 8 days post-treatment ] [ Designated as safety issue: No ]
    This study will measure as its primary endpoint the anterior chamber cell count at Day 8 post-treatment in the study eye. The proportion of patients with anterior chamber cell count = 0 at Day 8 in the study eye for each dosage group will be compared. Only one eye was treated per participant.


Enrollment: 42
Study Start Date: October 2010
Study Completion Date: May 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Dose 1
513ug
Drug: IBI-10090
Experimental: Dose 2
776ug
Drug: IBI-10090
Experimental: Dose 3
1046ug
Drug: IBI-10090

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female patients 40 years of age scheduled for unilateral cataract surgery (phacoemulsification or extracapsular extraction) with posterior chamber intraocular lens implantation.

Exclusion Criteria:

  • Patients who have used any ocular, topical, or oral corticosteroids within 7 days prior to Day 0.
  • Patients who have used topical ocular NSAIDs in the study eye within 15 days prior to screening.
  • Patients with any signs of intraocular inflammation in either eye at screening.
  • Patients who have received any prior intravitreal injections in the study eye.
  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: NCT01214174

Locations
United States, Oregon
Drs. Fine, Hoffman, and Packer
Eugene, Oregon, United States, 97401
Sponsors and Collaborators
ICON Bioscience Inc
Investigators
Principal Investigator: Mark Packer, MD Drs. Fine, Hoffman, Packer
  More Information

No publications provided

Responsible Party: ICON Bioscience Inc
ClinicalTrials.gov Identifier: NCT01214174     History of Changes
Other Study ID Numbers: C10-01
Study First Received: September 21, 2010
Results First Received: June 24, 2013
Last Updated: September 16, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by ICON Bioscience Inc:
cataract
inflammation

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

ClinicalTrials.gov processed this record on September 29, 2014