A Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of APP13007 to Treat Inflammation and Pain After Cataract Surgery
Completed · Phase 2 · Has a placebo group
Conditions studied: Ocular Inflammation and Pain After Cataract Surgery
In brief
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 matching vehicle placebo. Part A will be conducted first to evaluate 0.05% APP13007 and matching vehicle placebo in an approximate 1:1 ratio in approximately 42 subjects who experience postoperative inflammation on the first day following routine, uncomplicated, cataract surgery and who meet all eligibility criteria. Based on the results of Part A, Part B of the study may be open for enrollment to evaluate 0.05% and/or 0.1% APP13007 at various dosing frequency in approximately 84 subjects, also in an approximate 1:1 ratio, active vs. placebo. In each Part, subjects will return periodically for study assessments during the treatment period and then for a follow-up visit approximately 1 week after stopping the study drug.
Key facts
- Study ID
- NCT04089735
- Run by
- Formosa Pharmaceuticals, Inc.
- People needed
- 165
- Starts
- 2019-08-13
- Expected to finish
- 2020-04-07
- Last updated by the study team
- 2023-06-27
Who can join
Age: 50 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- Have an anterior chamber cell count > 0 or any evidence of intraocular inflammation.
- Have a score > 0 on Ocular Pain Assessment in either eye.
Where it is running
- Cornea and Cataract Consultants of Arizona — Phoenix, Arizona, United States
- United Medical Research Institute — Inglewood, California, United States
- Martel Eye Medical Group — Rancho Cordova, California, United States
- Levenson Eye Associates — Jacksonville, Florida, United States
- Bowden Eye and Associates — Jacksonville, Florida, United States
- Ophthalmology Associates — St Louis, Missouri, United States
- Eye Care Specialists — Kingston, Pennsylvania, United States
- Keystone Research Ltd. — Austin, Texas, United States
- Cataract & Glaucoma Center — El Paso, Texas, United States
Full record on ClinicalTrials.gov
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