Status:
COMPLETED
A Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of APP13007 to Treat Inflammation and Pain After Cataract Surgery
Lead Sponsor:
Formosa Pharmaceuticals, Inc.
Conditions:
Ocular Inflammation and Pain After Cataract Surgery
Eligibility:
All Genders
50+ years
Phase:
PHASE2
Brief Summary
This is a Phase 2a, 2-part study (designated Parts A and B) that will evaluate APP13007 dose strength and dosing frequency in a randomized double-masked fashion for comparison to the respective matchi...
Eligibility Criteria
Inclusion
- Expected to undergo unilateral uncomplicated cataract extraction via phacoemulsification and posterior chamber intraocular lens implantation in one eye.
- In Investigator's opinion, have Early Treatment Diabetic Retinopathy Study estimated potential of 0.7 (20/100) or better in study eye.
- Have \> 10 and ≤ 30 cells in anterior chamber.
- Have an intraocular pressure ≤ 30 mmHg.
Exclusion
- Have an anterior chamber cell count \> 0 or any evidence of intraocular inflammation.
- Have a score \> 0 on Ocular Pain Assessment in either eye.
Key Trial Info
Start Date :
August 13 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 7 2020
Estimated Enrollment :
165 Patients enrolled
Trial Details
Trial ID
NCT04089735
Start Date
August 13 2019
End Date
April 7 2020
Last Update
June 27 2023
Active Locations (9)
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1
Cornea and Cataract Consultants of Arizona
Phoenix, Arizona, United States, 85032
2
United Medical Research Institute
Inglewood, California, United States, 90301
3
Martel Eye Medical Group
Rancho Cordova, California, United States, 95670
4
Levenson Eye Associates
Jacksonville, Florida, United States, 32204