Status:
COMPLETED
Efficacy and Safety of APP13007 for Treatment of Inflammation and Pain After Cataract Surgery
Lead Sponsor:
Formosa Pharmaceuticals, Inc.
Conditions:
Ocular Inflammation and Pain
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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 surger...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 11 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 17 2022
Estimated Enrollment :
378 Patients enrolled
Trial Details
Trial ID
NCT04739709
Start Date
January 11 2021
End Date
March 17 2022
Last Update
July 20 2023
Active Locations (35)
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1
Schwartz Laser Eye Center
Scottsdale, Arizona, United States, 85260
2
Global Research Management
Glendale, California, United States, 91204
3
Inland Eye Specialists
Hemet, California, United States, 92545
4
SoCal Eye Physicians and Associates
Long Beach, California, United States, 90805