Clinical trial NCT04739709: Efficacy and Safety of APP13007 for Treatment of Inflammation and Pain After Cataract Surgery
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Ocular Inflammation and Pain
Lead sponsor: Formosa Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2021-02-05
Enrollment: 378
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 1; POD1) after uncomplicated surgery for eligibility for randomization to study treatment.


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 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 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
Secondary outcomes:
measure: Participants With Anterior Chamber Cell Grade = 0 at POD8 Without Rescue Medication
timeFrame: Postoperative Day 8
measure: Participants With Anterior Chamber Cell Grade = 0 at POD15 Without Rescue Medication
timeFrame: Postoperative Day 15
measure: Participants With Ocular Pain Grade = 0 at POD4 Without Rescue Medication
timeFrame: Postoperative Day 4
measure: Participants With Ocular Pain Grade = 0 at POD8 Without Rescue Medication
timeFrame: Postoperative Day 8
measure: Participants With Ocular Pain Grade = 0 at POD15 Without Rescue Medication
timeFrame: Postoperative Day 15
measure: Participants With Anterior Chamber Flare (ACF) = 0 at POD4 Without Rescue Medication
timeFrame: Postoperative Day 4
measure: Participants With Anterior Chamber Flare (ACF) = 0 at POD8 Without Rescue Medication
timeFrame: Postoperative Day 8
measure: Participants With Anterior Chamber Flare (ACF) = 0 at POD15 Without Rescue Medication
timeFrame: Postoperative Day 15
measure: Anterior Chamber Cell Grade - Change From Baseline (POD1 Prior to Dosing) to POD 15
timeFrame: Baseline and Postoperative Day 15
measure: Ocular Pain Grade - Change From Baseline (POD1 Prior to Dosing) to POD 15
timeFrame: Baseline and Postoperative Day 15
measure: Anterior Chamber Flare (ACF) - Change From Baseline (POD1 Prior to Dosing) to POD 15
timeFrame: Baseline and Postoperative Day 15
measure: Best Corrected Visual Acuity - Change From Baseline (POD1 Prior to Dosing) to POD4
timeFrame: Baseline and Postoperative Day 4
measure: Best Corrected Visual Acuity - Change From Baseline (POD1 Prior to Dosing) to POD8
timeFrame: Baseline and Postoperative Day 8
measure: Best Corrected Visual Acuity - 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:
Locations:
city: Scottsdale
country: United States
facility: Schwartz Laser Eye Center
state: Arizona
city: Glendale
country: United States
facility: Global Research Management
state: California
city: Hemet
country: United States
facility: Inland Eye Specialists
state: California
city: Long Beach
country: United States
facility: SoCal Eye Physicians and Associates
state: California
city: Mission Hills
country: United States
facility: North Valley Eye Medical Group, Inc.
state: California
city: Murrieta
country: United States
facility: LoBue Laser and Eye Medical Center, Inc.
state: California
city: Oceanside
country: United States
facility: Pendleton Eye Center
state: California
city: Rancho Cordova
country: United States
facility: Martel Eye Medical Group
state: California
city: Redding
country: United States
facility: Shasta Eye Medical Group, Inc.
state: California
city: Grand Junction
country: United States
facility: Icon Eye Care
state: Colorado
city: Jacksonville
country: United States
facility: Levenson Eye Associates
state: Florida
city: Ormond Beach
country: United States
facility: International Eye Associates, PA
state: Florida
city: Sebring
country: United States
facility: Newsom Eye and Laser Center
state: Florida
city: Roswell
country: United States
facility: Coastal Research Associates, LLC
state: Georgia
city: Columbus
country: United States
facility: Jacksoneye SC
state: Illinois
city: Carmel
country: United States
facility: Midwest Cornea Associates, LLC
state: Indiana
city: Louisville
country: United States
facility: Senior Health Services
state: Kentucky
city: Kansas City
country: United States
facility: Silverstein Eye Centers, PC
state: Missouri
city: Saint Louis
country: United States
facility: Ophthalmology Consultants, Ltd.
state: Missouri
city: Washington
country: United States
facility: Comprehensive Eye Care, Ltd.
state: Missouri
city: Henderson
country: United States
facility: NV Eye Surgery
state: Nevada
city: Las Vegas
country: United States
facility: Center For Sight
state: Nevada
city: New York
country: United States
facility: Raymond Fong, MD, PC
state: New York
city: Southern Pines
country: United States
facility: Carolina Eye Associates
state: North Carolina
city: Columbus
country: United States
facility: Eye Physicians, LLC
state: Ohio
city: Wilkes-Barre
country: United States
facility: Bucci Laser Vision Institute
state: Pennsylvania
city: Austin
country: United States
facility: Keystone Research Ltd.
state: Texas
city: Austin
country: United States
facility: Retina Research Center, PLLC
state: Texas
city: Houston
country: United States
facility: Houston Eye Associates
state: Texas
city: Houston
country: United States
facility: Advanced Laser Vision and Surgical Institute
state: Texas
city: Lakeway
country: United States
facility: Lake Travis Eye and Laser Center
state: Texas
city: San Antonio
country: United States
facility: R and R Eye Research, LLC
state: Texas
city: San Antonio
country: United States
facility: San Antonio Eye Center
state: Texas
city: Salt Lake City
country: United States
facility: Stacy R. Smith, MD, PC
state: Utah
city: San Juan
country: Puerto Rico
facility: Centro Oftalmologico Metropolitano
Study officials:
References: