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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01214174
Recruitment Status : Terminated (Study C11-01 started)
First Posted : October 4, 2010
Results First Posted : September 18, 2013
Last Update Posted : September 18, 2013
Sponsor:
Information provided by (Responsible Party):
ICON Bioscience Inc

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

Condition or disease Intervention/treatment Phase
Ocular Inflammation Drug: IBI-10090 Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 42 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, 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
Study Start Date : October 2010
Primary Completion Date : May 2012
Study Completion Date : May 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Dose 1
513ug
Drug: IBI-10090
Experimental: Dose 2
776ug
Drug: IBI-10090
Experimental: Dose 3
1046ug
Drug: IBI-10090



Primary Outcome Measures :
  1. Proportion of Patients With Anterior Chamber Cell Clearing 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 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: ICON Bioscience Inc
ClinicalTrials.gov Identifier: NCT01214174     History of Changes
Other Study ID Numbers: C10-01
First Posted: October 4, 2010    Key Record Dates
Results First Posted: September 18, 2013
Last Update Posted: September 18, 2013
Last Verified: September 2013

Keywords provided by ICON Bioscience Inc:
cataract
inflammation

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