Clinical trial NCT04089735: A Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of APP13007 to Treat Inflammation and Pain After Cataract Surgery
Official title: A Multicenter, Randomized, Double-Masked, Two-Part, Placebo-Controlled Phase 2A Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of APP13007 for the Treatment of Inflammation and Pain After Cataract Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Ocular Inflammation and Pain After Cataract Surgery
Lead sponsor: Formosa Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2019-09-13
Enrollment: 165
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a Phase 2a, 2-part study (designated Parts A and B) that will evaluate APP13007 dose strength and dosing frequency in a randomized double-masked fashion for comparison to the respective matching vehicle placebo. Part A will be conducted first to evaluate 0.05% APP13007 and matching vehicle placebo in an approximate 1:1 ratio in approximately 42 subjects who experience postoperative inflammation on the first day following routine, uncomplicated, cataract surgery and who meet all eligibility criteria. Based on the results of Part A, Part B of the study may be open for enrollment to evaluate 0.05% and/or 0.1% APP13007 at various dosing frequency in approximately 84 subjects, also in an approximate 1:1 ratio, active vs. placebo. In each Part, subjects will return periodically for study assessments during the treatment period and then for a follow-up visit approximately 1 week after stopping the study drug.


Eligibility criteria: Inclusion Criteria:

* Expected to undergo unilateral uncomplicated cataract extraction via phacoemulsification and posterior chamber intraocular lens implantation in one eye.
* In Investigator's opinion, have Early Treatment Diabetic Retinopathy Study estimated potential of 0.7 (20/100) or better in study eye.
* Have \> 10 and ≤ 30 cells in anterior chamber.
* Have an intraocular pressure ≤ 30 mmHg.

Exclusion Criteria:

* Have an anterior chamber cell count \> 0 or any evidence of intraocular inflammation.
* Have a score \> 0 on Ocular Pain Assessment in either eye.

Primary outcomes:
measure: Number of Treatment Emergent Adverse Events
timeFrame: From First dose to Post-operative Day 28 (Part A) or Day 22 (Part B)
measure: Intraocular Pressure - Change From Baseline (POD1 Prior to Dosing) to End-of-Treatment in the Operated Study Eye
timeFrame: Baseline and Post-operative Day 22 (Part A) or Day 15 (Part B)
measure: Absolute Anterior Chamber Cell Count - Change From Baseline (POD1 Prior to Dosing) to POD 15 in the Operated Study Eye
timeFrame: Baseline and Post-operative Day 15
measure: Visual Acuity - Change From Baseline (POD1 Prior to Dosing) to End-of Treatment in the Operated Study Eye
timeFrame: Baseline and Post-operative Day 22 (Part A) or Day 15 (Part B)
measure: Ocular Pain Grade - Change From Baseline (POD1 Prior to Dosing) to POD15 in the Operated Study Eye
timeFrame: Baseline and Post-operative Day 15
Secondary outcomes:
measure: Subjects With Anterior Chamber Cell Count = 0 at POD15 in the Operated Study Eye Without Rescue Medication
timeFrame: Post-operative Day 15
measure: Subjects With Ocular Pain Grade = 0 at POD 15 in the Operated Study Eye Without Rescue Medication
timeFrame: Post-operative Day 15
measure: Anterior Chamber Flare - Change From Baseline (POD1 Prior to Dosing) to End-of Treatment in the Operated Study Eye
timeFrame: Baseline and Post-operative Day 22 (Part A) or Day 15 (Part B)
measure: Subjects Using of Anti-inflammatory 'Rescue' Medication Through End-of-Treatment
timeFrame: First dose to Post-operative Day 22 (Part A) or Day 15 (Part B)
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Cornea and Cataract Consultants of Arizona
state: Arizona
city: Inglewood
country: United States
facility: United Medical Research Institute
state: California
city: Rancho Cordova
country: United States
facility: Martel Eye Medical Group
state: California
city: Jacksonville
country: United States
facility: Levenson Eye Associates
state: Florida
city: Jacksonville
country: United States
facility: Bowden Eye and Associates
state: Florida
city: Saint Louis
country: United States
facility: Ophthalmology Associates
state: Missouri
city: Kingston
country: United States
facility: Eye Care Specialists
state: Pennsylvania
city: Austin
country: United States
facility: Keystone Research Ltd.
state: Texas
city: El Paso
country: United States
facility: Cataract & Glaucoma Center
state: Texas
Study officials:
affiliation: AimMax Therapeutics Inc.
name: Chief Medical Officer
role: STUDY_DIRECTOR
References: