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

Formosa Pharmaceuticals

Status and phase: Completed; Phase 3

Conditions: Ocular Inflammation and Pain After Cataract Surgery

Treatments: Drug: APP13007, 0.05%; Drug: Matching Vehicle Placebo for APP13007, 0.05%

Study type: Interventional

Funder types: Industry

Identifiers

NCT04810962

CPN-302

Details and patient eligibility

About

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.

Enrollment: 370 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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370 participants in 2 patient groups, including a placebo group

APP13007 0.05% BID

Experimental group

Description:

1 drop APP13007 0.05% twice daily for 14 days to study (operated) eye

Treatment:

Drug: APP13007, 0.05%

Matching Vehicle Placebo

Placebo Comparator group

Description:

1 drop matching vehicle placebo twice daily for 14 days to study (operated) eye

Treatment:

Drug: Matching Vehicle Placebo for APP13007, 0.05%