A Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of APP13007 to Treat Inflammation and Pain After Cataract Surgery

• Status: Completed
• Trial end date: 2020-04-07
• Target enrollment: 0
• Participant gender: All

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 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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Formosa Pharmaceuticals, Inc.

Criteria

Inclusion Criteria:

• 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 Criteria:

• Have an anterior chamber cell count > 0 or any evidence of intraocular inflammation.

• Have a score > 0 on Ocular Pain Assessment in either eye.