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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
ICON Bioscience Inc
ClinicalTrials.gov Identifier:
NCT01214174
First received: September 21, 2010
Last updated: August 16, 2012
Last verified: August 2012
History of Changes
  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
Phase 3

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:

MedlinePlus related topics: Cataract
U.S. FDA Resources

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. The proportion of patients with anterior chamber cell count = 0 at Day 8 for each dosage group will be compared.


Estimated Enrollment: 228
Study Start Date: September 2010
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 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
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
Last Updated: August 16, 2012
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 May 16, 2013