Efficacy and Safety of APP13007 for Treatment of Inflammation and Pain After Cataract Surgery

Completed · Phase 3 · Has a placebo group

Conditions studied: Ocular Inflammation and Pain

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 1; POD1) after uncomplicated surgery for eligibility for randomization to study treatment.

Key facts

Study ID

NCT04739709

Run by

Formosa Pharmaceuticals, Inc.

People needed

378

Starts

2021-01-11

Expected to finish

2022-03-17

Last updated by the study team

2023-07-20

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

• Schwartz Laser Eye Center — Scottsdale, Arizona, United States
• Global Research Management — Glendale, California, United States
• Inland Eye Specialists — Hemet, California, United States
• SoCal Eye Physicians and Associates — Long Beach, California, United States
• North Valley Eye Medical Group, Inc. — Mission Hills, California, United States
• LoBue Laser and Eye Medical Center, Inc. — Murrieta, California, United States
• Pendleton Eye Center — Oceanside, California, United States
• Martel Eye Medical Group — Rancho Cordova, California, United States
• Shasta Eye Medical Group, Inc. — Redding, California, United States
• Icon Eye Care — Grand Junction, Colorado, United States
• Levenson Eye Associates — Jacksonville, Florida, United States
• International Eye Associates, PA — Ormond Beach, Florida, United States
• Newsom Eye and Laser Center — Sebring, Florida, United States
• Coastal Research Associates, LLC — Roswell, Georgia, United States
• Jacksoneye SC — Columbus, Illinois, United States
• Midwest Cornea Associates, LLC — Carmel, Indiana, United States
• Senior Health Services — Louisville, Kentucky, United States
• Silverstein Eye Centers, PC — Kansas City, Missouri, United States
• Ophthalmology Consultants, Ltd. — St Louis, Missouri, United States
• Comprehensive Eye Care, Ltd. — Washington, Missouri, United States
• NV Eye Surgery — Henderson, Nevada, United States
• Center For Sight — Las Vegas, Nevada, United States
• Raymond Fong, MD, PC — New York, New York, United States
• Carolina Eye Associates — Southern Pines, North Carolina, United States
• Eye Physicians, LLC — Columbus, Ohio, United States

Full record on ClinicalTrials.gov

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