Clinical trial NCT04810962: Efficacy and Safety of APP13007 for Treatment of Inflammation and Pain After Cataract Surgery Including a Corneal Endothelial Cell Sub-study
Official title: A Multicenter, Randomized, Double-Masked, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of APP13007 for the Treatment of Inflammation and Pain After Cataract Surgery, Including a Corneal Endothelial Cell Sub-study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Ocular Inflammation and Pain After Cataract Surgery
Lead sponsor: Formosa Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2021-03-23
Enrollment: 370
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Participants With ACC Count = 0 in the Operated Study Eye at All Visits From Postoperative Day 8 Through Postoperative Day 15 Without Rescue Medication
timeFrame: Postoperative Day 8 and Postoperative Day 15
measure: Participants With Ocular Pain Grade = 0 in the Operated Study Eye at All Visits From Postoperative Day 4 Through Postoperative Day 15 Without Rescue Medication
timeFrame: Postoperative Day 4, Postoperative Day 8 and Postoperative Day 15
measure: Participants With Treatment-emergent Adverse Events (AEs)
timeFrame: From First dose to Postoperative Day 22 (End of Main Study)
Secondary outcomes:
measure: Participants With Anterior Chamber Cell Grade = 0 in the Operated Study Eye at POD8 Without Rescue Medication
timeFrame: Postoperative Day 8
measure: Participants With Anterior Chamber Cell Grade = 0 in the Operated Study Eye at POD15 Without Rescue Medication
timeFrame: Postoperative Day 15
measure: Participants With Ocular Pain Grade = 0 in the Operated Study Eye at POD4 Without Rescue Medication
timeFrame: Postoperative Day 4
measure: Participants With Ocular Pain Grade = 0 in the Operated Study Eye at POD8 Without Rescue Medication
timeFrame: Postoperative Day 8
measure: Participants With Ocular Pain Grade = 0 in the Operated Study Eye at POD15 Without Rescue Medication
timeFrame: Postoperative Day 15
measure: Participants With Anterior Chamber Flare (ACF) = 0 in the Operated Study Eye at POD4 Without Rescue Medication
timeFrame: Postoperative Day 4
measure: Participants With Anterior Chamber Flare (ACF) = 0 in the Operated Study Eye at POD8 Without Rescue Medication
timeFrame: Postoperative Day 8
measure: Participants With Anterior Chamber Flare (ACF) = 0 in the Operated Study Eye at POD15 Without Rescue Medication
timeFrame: Postoperative Day 15
measure: Anterior Chamber Cell Grade in the Operated Study Eye - Change From Baseline (POD1 Prior to Dosing) to POD 15
timeFrame: Baseline and Postoperative Day 15
measure: Ocular Pain Grade in the Operated Study Eye - Change From Baseline (POD1 Prior to Dosing) to POD 15
timeFrame: Baseline and Postoperative Day 15
measure: Anterior Chamber Flare (ACF) in the Operated Study Eye - Change From Baseline (POD1 Prior to Dosing) to POD 15
timeFrame: Baseline and Postoperative Day 15
measure: Best Corrected Visual Acuity in the Operated Study Eye - Change From Baseline (POD1 Prior to Dosing) to POD4
timeFrame: Baseline and Postoperative Day 4
measure: Best Corrected Visual Acuity in the Operated Study Eye - Change From Baseline (POD1 Prior to Dosing) to POD8
timeFrame: Baseline and Postoperative Day 8
measure: Best Corrected Visual Acuity in the Operated Study Eye - Change From Baseline (POD1 Prior to Dosing) to POD15
timeFrame: Baseline and Postoperative Day 15
measure: Participants Using of Anti-inflammatory 'Rescue' Medication Through End-of-Treatment
timeFrame: First dose to Postoperative Day 15
Other outcomes:
measure: Corneal Endothelial Cell Density - Mean Change From Screening to Postoperative Day 85
timeFrame: Screening and Postoperative Day 85
Locations:
city: Chandler
country: United States
facility: Arizona Eye Center
state: Arizona
city: Mesa
country: United States
facility: Carrot Eye Center
state: Arizona
city: Phoenix
country: United States
facility: Cornea and Cataract Consultants of Arizona
state: Arizona
city: Garden Grove
country: United States
facility: Orange County Ophthalmology Medical Group
state: California
city: Los Angeles
country: United States
facility: Premiere Practice Management, LLC
state: California
city: Murrieta
country: United States
facility: LoBue Laser and Eye Medical Center Inc
state: California
city: Newport Beach
country: United States
facility: Visionary Research Institute
state: California
city: Petaluma
country: United States
facility: North Bay Eye Associates
state: California
city: Torrance
country: United States
facility: Wolstan and Goldberg Eye Associates
state: California
city: Westminster
country: United States
facility: Michael K. Tran, MD, Inc.
state: California
city: Deerfield Beach
country: United States
facility: Rand Eye Institute
state: Florida
city: Fort Myers
country: United States
facility: Eye Associates for Fort Myers
state: Florida
city: Jacksonville
country: United States
facility: Levenson Eye Associates
state: Florida
city: Tampa
country: United States
facility: International Research Center
state: Florida
city: Albany
country: United States
facility: Dixon Eye Care
state: Georgia
city: Morrow
country: United States
facility: Clayton Eye Clinical Research LLC
state: Georgia
city: Hoffman Estates
country: United States
facility: Chicago Cornea Consultants
state: Illinois
city: Overland Park
country: United States
facility: Stiles Eyecare Excellence and Glaucoma Institute, PA
state: Kansas
city: Louisville
country: United States
facility: The Eye Care Center
state: Kentucky
city: Fraser
country: United States
facility: Fraser Eye Center
state: Michigan
city: Saint Louis
country: United States
facility: Ophthalmology Associates
state: Missouri
city: Las Vegas
country: United States
facility: Wellish Vision Institute
state: Nevada
city: Palisades Park
country: United States
facility: Metropolitan Eye Research and Surgery Institute
state: New Jersey
city: Poughkeepsie
country: United States
facility: Alterman, Modi and Wolter
state: New York
city: Cincinnati
country: United States
facility: Cincinnati Eye Institute
state: Ohio
city: Kingston
country: United States
facility: Eye Care Specialists
state: Pennsylvania
city: Ladson
country: United States
facility: Carolina Cataract and Laser Center
state: South Carolina
city: Rapid City
country: United States
facility: Black Hills Regional Eye Institute
state: South Dakota
city: Houston
country: United States
facility: Houston Eye Associates
state: Texas
city: Mission
country: United States
facility: DCT-Shah Research Institute LLC dba Discovery Clinical Trials
state: Texas
city: Round Rock
country: United States
facility: Round Rock Eye Consultants
state: Texas
Study officials:
affiliation: AimMax Therapeutics Inc.
name: Chief Medical Officer
role: STUDY_DIRECTOR
References: