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

  • STATUS
    Recruiting
  • End date
    Feb 28, 2022
  • participants needed
    370
  • sponsor
    Formosa Pharmaceuticals, Inc.
Updated on 1 September 2021
Investigator
Clinical Ops Representative
Primary Contact
Chicago Cornea Consultants (7.9 mi away) Contact
+29 other location

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 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.

Details
Condition Ocular Inflammation and Pain After Cataract Surgery
Treatment APP13007, 0.05%, Matching Vehicle Placebo for APP13007, 0.05%
Clinical Study IdentifierNCT04810962
SponsorFormosa Pharmaceuticals, Inc.
Last Modified on1 September 2021

Eligibility

Yes No Not Sure

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
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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