Back to resultsEfficacy and Safety of IBI-10090 in Ocular Surgery Patients
Primary Purpose
Inflammation Associated With Cataract Surgery
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
IBI-10090
Sponsored by
About this trial
This is an interventional treatment trial for Inflammation Associated With Cataract Surgery focused on measuring cataract surgery, ocular inflammation
Eligibility Criteria
Inclusion Criteria:
- Patients scheduled for unilateral cataract surgery
Exclusion Criteria:
- Ocular, topical, or oral corticosteroids within 7 days of Day 0
Sites / Locations
- Inland Eye Specialists
- California Eye Professionals
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
Outcomes
Primary Outcome Measures
Anterior Chamber Cell Count at Day 8 Post-Treatment
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01606735
Brief Title
Efficacy and Safety of IBI-10090 in Ocular Surgery Patients
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2014
Overall Recruitment Status
Completed
Study Start Date
April 2012 (undefined)
Primary Completion Date
March 2013 (Actual)
Study Completion Date
March 2013 (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 ocular surgery.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inflammation Associated With Cataract Surgery
Keywords
cataract surgery, ocular inflammation
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
172 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Dose 1
Arm Type
Experimental
Arm Title
Dose 2
Arm Type
Experimental
Arm Title
Dose 3
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
IBI-10090
Intervention Description
dexamethasone
Primary Outcome Measure Information:
Title
Anterior Chamber Cell Count at Day 8 Post-Treatment
Description
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.
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:
Patients scheduled for unilateral cataract surgery
Exclusion Criteria:
Ocular, topical, or oral corticosteroids within 7 days of Day 0
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wendy Murahashi, MD
Organizational Affiliation
Sponsor GmbH
Official's Role
Study Director
Facility Information:
Facility Name
Inland Eye Specialists
City
Hemet
State/Province
California
ZIP/Postal Code
92545
Country
United States
Facility Name
California Eye Professionals
City
Temecula
State/Province
California
ZIP/Postal Code
92591
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Efficacy and Safety of IBI-10090 in Ocular Surgery Patients
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