A Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of APP13007 to Treat Inflammation and Pain After Cataract Surgery

Ocular Inflammation and Pain After Cataract Surgery Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04089735
• Other study ID #: CPN-201
• Status: Completed
• Phase: Phase 2
• Start date: August 13, 2019
• Est. completion date: April 7, 2020

Study information

• Verified date: June 2023
• Source: Formosa Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 165
• Est. completion date: April 7, 2020
• Est. primary completion date: April 7, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Capsule Opacification
• Cataract
• Inflammation
• Ocular Inflammation and Pain After Cataract Surgery

Intervention

Drug:
• APP13007, 0.05%
APP13007 eye drop, 0.05%
• APP13007, 0.1%
APP13007 eye drop, 0.1%
• APP13007 Placebo, 0.05%
APP13007 placebo eyedrop, 0.05%
• APP13007 Placebo, 0.1%
APP13007 placebo eyedrop, 0.1%

Locations

Country	Name	City	State
United States	Keystone Research Ltd.	Austin	Texas
United States	Cataract & Glaucoma Center	El Paso	Texas
United States	United Medical Research Institute	Inglewood	California
United States	Bowden Eye and Associates	Jacksonville	Florida
United States	Levenson Eye Associates	Jacksonville	Florida
United States	Eye Care Specialists	Kingston	Pennsylvania
United States	Cornea and Cataract Consultants of Arizona	Phoenix	Arizona
United States	Martel Eye Medical Group	Rancho Cordova	California
United States	Ophthalmology Associates	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Formosa Pharmaceuticals, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Treatment Emergent Adverse Events	Number of treatment emergent adverse events and number of participants.	From First dose to Post-operative Day 28 (Part A) or Day 22 (Part B)
Primary	Intraocular Pressure - Change From Baseline (POD1 Prior to Dosing) to End-of-Treatment in the Operated Study Eye	Intraocular pressure is measured in mm Hg at each study visit with a Goldmann applanation tonometer. The change from baseline is calculated by subtracting the pretreatment measurement value from the value at each visit.	Baseline and Post-operative Day 22 (Part A) or Day 15 (Part B)
Primary	Absolute Anterior Chamber Cell Count - Change From Baseline (POD1 Prior to Dosing) to POD 15 in the Operated Study Eye	The number of cells in the anterior chamber of the eye are counted using slit-lamp biomicroscopy at each study visit and the results are reported as number of cells in a 1mm x 1mm area.	Baseline and Post-operative Day 15
Primary	Visual Acuity - Change From Baseline (POD1 Prior to Dosing) to End-of Treatment in the Operated Study Eye	The visual acuity in each eye is corrected using the pinhole method and the acuity is quantified on a logMAR (minimal angle of resolution) scale using the 'Early Treatment Diabetic Retinopathy Study' [ETDRS] charts for right and left eyes. A logMAR Score is calculated using the number of incorrect letters.	Baseline and Post-operative Day 22 (Part A) or Day 15 (Part B)
Primary	Ocular Pain Grade - Change From Baseline (POD1 Prior to Dosing) to POD15 in the Operated Study Eye	Ocular pain is measured in each eye using a subject-reported five-point (0-4) ocular pain grade scale (0 = no pain; 4 = severe pain).	Baseline and Post-operative Day 15
Secondary	Subjects With Anterior Chamber Cell Count = 0 at POD15 in the Operated Study Eye Without Rescue Medication	The number of cells in the anterior chamber of the eye are counted using slit-lamp biomicroscopy at each study visit and the results are reported as number of cells in a 1mm x 1mm area.	Post-operative Day 15
Secondary	Subjects With Ocular Pain Grade = 0 at POD 15 in the Operated Study Eye Without Rescue Medication	Ocular pain is measured in each eye using a subject-reported five-point (0-4) ocular pain grade scale (0 = no pain; 4 = severe pain).	Post-operative Day 15
Secondary	Anterior Chamber Flare - Change From Baseline (POD1 Prior to Dosing) to End-of Treatment in the Operated Study Eye	The degree of turbidity (flare) in the anterior chamber of the eye is measured using slit-lamp biomicroscopy and quantified on a five-point (0-4) anterior chamber flare grade scale (0 = none; 4 = Intense). The change from baseline is calculated by subtracting the pretreatment measurement value from the value at each visit.	Baseline and Post-operative Day 22 (Part A) or Day 15 (Part B)
Secondary	Subjects Using of Anti-inflammatory 'Rescue' Medication Through End-of-Treatment	Subjects who do not respond to study treatment after randomization (anterior chamber cell count > 30 cells or an increase in anterior chamber cell count by > 15 cells from pre-dose baseline or = 2 grade of increase in anterior chamber flare from pre-dose baseline) are started on anti-inflammatory medication (referred to as 'Rescue' medication). The number of subjects starting 'Rescue' medication is recorded at each study visit.	First dose to Post-operative Day 22 (Part A) or Day 15 (Part B)