Study Stopped
Study was terminated in order to examine study data.
Efficacy and Safety Study of IBI-10090 in Patients Undergoing Cataract Surgery
A Multicenter, Randomized, Double-masked, Dose-ranging, Phase 2 Study to Evaluate the Efficacy and Safety of IBI-10090 in Cataract Surgery Patients
1 other identifier
interventional
6
1 country
1
Brief Summary
This study will test the efficacy and safety of IBI-10090 for the reduction of ocular inflammation after cataract surgery.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Jan 2010
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2010
CompletedFirst Submitted
Initial submission to the registry
January 11, 2010
CompletedFirst Posted
Study publicly available on registry
January 13, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2010
CompletedResults Posted
Study results publicly available
August 16, 2012
CompletedDecember 4, 2018
November 1, 2018
4 months
January 11, 2010
May 24, 2012
November 6, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Clearance of Anterior Chamber Cells
Efficacy was assessed by slit lamp biomicroscopy to evaluate the anterior chamber cells (ACC) graded on a scale of 0 to 4. The primary efficacy endpoint was complete clearing of ACC, where grade 0 = 0 cells in the anterior chamber on POD 8.
Day 8 post treatment
Secondary Outcomes (4)
Anterior Chamber Flare (ACF) Grade
Day 90 post-treatment
Conjunctival Erythema Grade
Day 90 post-treatment
Corneal Edema Grade
Day 90 post-treatment
Anterior Chamber Cell Grade
Day 90 post-treatment
Study Arms (3)
Dose 1
EXPERIMENTAL114ug
Dose 2
EXPERIMENTAL513ug
Dose 3
EXPERIMENTAL684ug
Interventions
Eligibility Criteria
You may qualify if:
- Male or female patients 40 years of age scheduled for unilateral cataract surgery (phacoemulsification or extracapsular extraction) with posterior chamber intraocular lens implantation.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Altos Eye Physicians
Los Altos, California, 94024, United States
Limitations and Caveats
Early termination leading to small numbers of subjects analyzed.
Results Point of Contact
- Title
- Regulatory Affairs Specialist
- Organization
- Eyepoint Pharmaceuticals, Inc.
Study Officials
- PRINCIPAL INVESTIGATOR
David Chang, MD
Altos Eye Physicians
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 11, 2010
First Posted
January 13, 2010
Study Start
January 1, 2010
Primary Completion
May 1, 2010
Study Completion
June 1, 2010
Last Updated
December 4, 2018
Results First Posted
August 16, 2012
Record last verified: 2018-11