Efficacy and Safety of APP13007 for Treatment of Inflammation and Pain After Cataract Surgery Including a Corneal Endothelial Cell Sub-study

Completed · Phase 3 · Has a placebo group

Conditions studied: Ocular Inflammation and Pain After Cataract Surgery

In brief

This Phase 3 study will evaluate APP13007 in comparison to the matching vehicle placebo in a randomized, parallel-group, double-masked fashion. The subjects will have undergone routine cataract surgery on Day 0 of the study and will be assessed the next day (Post-operative Day; POD1) after uncomplicated surgery for eligibility for randomization to study treatment. The study comprises the Main Study and the Endothelial Cell Sub-study.

Key facts

Study ID

NCT04810962

Run by

Formosa Pharmaceuticals, Inc.

People needed

370

Starts

2021-03-16

Expected to finish

2022-07-06

Last updated by the study team

2023-07-25

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients 18 years of age or older expected to undergo unilateral uncomplicated cataract extraction via phacoemulsification and posterior chamber intraocular lens implantation in one eye.
• Have a pin-hole corrected visual acuity without other correction of ≤ 1.3 logarithm of the minimum angle of resolution (logMAR) in the study eye to be operated and contralateral eye as measured using an Early Treatment Diabetic Retinopathy Study (ETDRS) chart at Visit 1.
• Willing and able to comply with study requirements and visit schedule.
• Provide signed and dated informed consent.

You may not qualify if…

• Have a known sensitivity or allergy to clobetasol propionate, corticosteroids, or any of the study medication's components including benzalkonium chloride and soybean lecithin or any routine medication required during cataract surgery or for the conduct of study procedures
• Have an ACC count > 0 or any evidence of intraocular inflammation (e.g., flare) in either eye at the Screening visit
• Have a Grade > 0 on the Ocular Pain Assessment in either eye at the Screening visit
• Note: Other inclusion/exclusion criteria apply.

Where it is running

• Arizona Eye Center — Chandler, Arizona, United States
• Carrot Eye Center — Mesa, Arizona, United States
• Cornea and Cataract Consultants of Arizona — Phoenix, Arizona, United States
• Orange County Ophthalmology Medical Group — Garden Grove, California, United States
• Premiere Practice Management, LLC — Los Angeles, California, United States
• LoBue Laser and Eye Medical Center Inc — Murrieta, California, United States
• Visionary Research Institute — Newport Beach, California, United States
• North Bay Eye Associates — Petaluma, California, United States
• Wolstan and Goldberg Eye Associates — Torrance, California, United States
• Michael K. Tran, MD, Inc. — Westminster, California, United States
• Rand Eye Institute — Deerfield Beach, Florida, United States
• Eye Associates for Fort Myers — Fort Myers, Florida, United States
• Levenson Eye Associates — Jacksonville, Florida, United States
• International Research Center — Tampa, Florida, United States
• Dixon Eye Care — Albany, Georgia, United States
• Clayton Eye Clinical Research LLC — Morrow, Georgia, United States
• Chicago Cornea Consultants — Hoffman Estates, Illinois, United States
• Stiles Eyecare Excellence and Glaucoma Institute, PA — Overland Park, Kansas, United States
• The Eye Care Center — Louisville, Kentucky, United States
• Fraser Eye Center — Fraser, Michigan, United States
• Ophthalmology Associates — St Louis, Missouri, United States
• Wellish Vision Institute — Las Vegas, Nevada, United States
• Metropolitan Eye Research and Surgery Institute — Palisades Park, New Jersey, United States
• Alterman, Modi and Wolter — Poughkeepsie, New York, United States
• Cincinnati Eye Institute — Cincinnati, Ohio, United States

Full record on ClinicalTrials.gov

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