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Status:

COMPLETED

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

Lead Sponsor:

Formosa Pharmaceuticals, Inc.

Conditions:

Ocular Inflammation and Pain After Cataract Surgery

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 :

March 16 2021

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

July 6 2022

Estimated Enrollment :

370 Patients enrolled

Trial Details

Trial ID

NCT04810962

Start Date

March 16 2021

End Date

July 6 2022

Last Update

July 25 2023

Active Locations (31)

Enter a location and click search to find clinical trials sorted by distance.

Page 1 of 8 (31 locations)

1

Arizona Eye Center

Chandler, Arizona, United States, 85224

2

Carrot Eye Center

Mesa, Arizona, United States, 85260

3

Cornea and Cataract Consultants of Arizona

Phoenix, Arizona, United States, 85032

4

Orange County Ophthalmology Medical Group

Garden Grove, California, United States, 92843