Back to resultsEfficacy and Safety Study of IBI-10090 in Cataract Surgery Patients
Primary Purpose
Ocular Inflammation
Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
IBI-10090
Sponsored by
About this trial
This is an interventional treatment trial for Ocular Inflammation focused on measuring cataract, inflammation
Eligibility 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.
Sites / Locations
- Drs. Fine, Hoffman, and Packer
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Dose 1
Dose 2
Dose 3
Arm Description
513ug
776ug
1046ug
Outcomes
Primary Outcome Measures
Proportion of Patients With Anterior Chamber Cell Clearing at Day 8 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.
Secondary Outcome Measures
Full Information
NCT ID
NCT01214174
First Posted
September 21, 2010
Last Updated
September 16, 2013
Sponsor
ICON Bioscience Inc
1. Study Identification
Unique Protocol Identification Number
NCT01214174
Brief Title
Efficacy and Safety Study of IBI-10090 in Cataract Surgery Patients
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 Type
Interventional
2. Study Status
Record Verification Date
September 2013
Overall Recruitment Status
Terminated
Why Stopped
Study C11-01 started
Study Start Date
October 2010 (undefined)
Primary Completion Date
May 2012 (Actual)
Study Completion Date
May 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ICON Bioscience Inc
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study will test the efficacy and safety of IBI-10090 in the treatment of ocular inflammation after cataract surgery.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ocular Inflammation
Keywords
cataract, inflammation
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
42 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Dose 1
Arm Type
Experimental
Arm Description
513ug
Arm Title
Dose 2
Arm Type
Experimental
Arm Description
776ug
Arm Title
Dose 3
Arm Type
Experimental
Arm Description
1046ug
Intervention Type
Drug
Intervention Name(s)
IBI-10090
Primary Outcome Measure Information:
Title
Proportion of Patients With Anterior Chamber Cell Clearing at Day 8 Post-Treatment
Description
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.
Time Frame
8 days post-treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark Packer, MD
Organizational Affiliation
Drs. Fine, Hoffman, Packer
Official's Role
Principal Investigator
Facility Information:
Facility Name
Drs. Fine, Hoffman, and Packer
City
Eugene
State/Province
Oregon
ZIP/Postal Code
97401
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Efficacy and Safety Study of IBI-10090 in Cataract Surgery Patients
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