- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04089735
A Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of APP13007 to Treat Inflammation and Pain After Cataract Surgery
June 1, 2023 updated by: Formosa Pharmaceuticals, Inc.
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
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.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
165
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Arizona
-
Phoenix, Arizona, United States, 85032
- Cornea and Cataract Consultants of Arizona
-
-
California
-
Inglewood, California, United States, 90301
- United Medical Research Institute
-
Rancho Cordova, California, United States, 95670
- Martel Eye Medical Group
-
-
Florida
-
Jacksonville, Florida, United States, 32204
- Levenson Eye Associates
-
Jacksonville, Florida, United States, 32256
- Bowden Eye and Associates
-
-
Missouri
-
Saint Louis, Missouri, United States, 63131
- Ophthalmology Associates
-
-
Pennsylvania
-
Kingston, Pennsylvania, United States, 18704
- Eye Care Specialists
-
-
Texas
-
Austin, Texas, United States, 78731
- Keystone Research Ltd.
-
El Paso, Texas, United States, 79902
- Cataract & Glaucoma Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
50 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: APP13007 0.05% twice daily (BID) [Part A]
1 drop 0.05% APP13007 twice daily for 21 days to the operated eye
|
APP13007 eye drop, 0.05%
|
Experimental: APP13007 0.05% Placebo twice daily (BID) [Part A]
1 drop matching vehicle placebo for 0.05% APP13007 twice daily for 21 days to the operated eye
|
APP13007 placebo eyedrop, 0.05%
|
Experimental: APP13007 0.05% twice daily (BID) and once daily (QD) [Part B]
1 drop 0.05% APP13007 twice daily for 3 days followed by 1 drop once daily for 11 days to the operated eye
|
APP13007 eye drop, 0.05%
|
Experimental: APP13007 0.05% Placebo twice daily (BID) and once daily (QD) [Part B]
1 drop matching vehicle placebo for 0.05% APP13007 twice daily for 3 days followed by 1 drop once daily for 11 days to the operated eye
|
APP13007 placebo eyedrop, 0.05%
|
Experimental: APP13007 0.1% twice daily (BID) and once daily (QD) [Part B]
1 drop 0.1% APP13007 twice daily for 3 days followed by 1 drop once daily for 11 days to the operated eye
|
APP13007 eye drop, 0.1%
|
Experimental: APP13007 0.1% Placebo twice daily (BID) and once daily (QD) [Part B]
1 drop matching vehicle placebo for 0.1% APP13007 twice daily for 3 days followed by 1 drop once daily for 11 days to the operated eye
|
APP13007 placebo eyedrop, 0.1%
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Treatment Emergent Adverse Events
Time Frame: From First dose to Post-operative Day 28 (Part A) or Day 22 (Part B)
|
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)
|
Intraocular Pressure - Change From Baseline (POD1 Prior to Dosing) to End-of-Treatment in the Operated Study Eye
Time Frame: Baseline and Post-operative Day 22 (Part A) or Day 15 (Part B)
|
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)
|
Absolute Anterior Chamber Cell Count - Change From Baseline (POD1 Prior to Dosing) to POD 15 in the Operated Study Eye
Time Frame: Baseline and Post-operative Day 15
|
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
|
Visual Acuity - Change From Baseline (POD1 Prior to Dosing) to End-of Treatment in the Operated Study Eye
Time Frame: Baseline and Post-operative Day 22 (Part A) or Day 15 (Part B)
|
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)
|
Ocular Pain Grade - Change From Baseline (POD1 Prior to Dosing) to POD15 in the Operated Study Eye
Time Frame: Baseline and Post-operative Day 15
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Subjects With Anterior Chamber Cell Count = 0 at POD15 in the Operated Study Eye Without Rescue Medication
Time Frame: Post-operative Day 15
|
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
|
Subjects With Ocular Pain Grade = 0 at POD 15 in the Operated Study Eye Without Rescue Medication
Time Frame: Post-operative Day 15
|
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
|
Anterior Chamber Flare - Change From Baseline (POD1 Prior to Dosing) to End-of Treatment in the Operated Study Eye
Time Frame: Baseline and Post-operative Day 22 (Part A) or Day 15 (Part B)
|
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)
|
Subjects Using of Anti-inflammatory 'Rescue' Medication Through End-of-Treatment
Time Frame: First dose to Post-operative Day 22 (Part A) or Day 15 (Part B)
|
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)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Chief Medical Officer, AimMax Therapeutics Inc.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 13, 2019
Primary Completion (Actual)
April 7, 2020
Study Completion (Actual)
April 7, 2020
Study Registration Dates
First Submitted
August 28, 2019
First Submitted That Met QC Criteria
September 12, 2019
First Posted (Actual)
September 13, 2019
Study Record Updates
Last Update Posted (Actual)
June 27, 2023
Last Update Submitted That Met QC Criteria
June 1, 2023
Last Verified
June 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CPN-201
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Ocular Inflammation and Pain After Cataract Surgery
-
Formosa Pharmaceuticals, Inc.CompletedOcular Inflammation and Pain After Cataract SurgeryUnited States
-
Ocular Therapeutix, Inc.CompletedPost-Surgical Ocular Pain | Post-Surgical Ocular Inflammation
-
Ocular Therapeutix, Inc.CompletedPost-Surgical Ocular Pain | Post-Surgical Ocular Inflammation
-
Formosa Pharmaceuticals, Inc.CompletedOcular Inflammation and PainUnited States, Puerto Rico
-
Ocular Therapeutix, Inc.CompletedOcular Inflammation and PainUnited States
-
Evolutec GroupUnknownOcular InflammationUnited States
-
Reata, a wholly owned subsidiary of BiogenAbbVieCompletedOcular Inflammation | Ocular Pain | Corneal Endothelial Cell Loss | Cataract SurgeryUnited States
-
SandozCompletedInflammation Following Ocular SurgeryCanada
-
Silverstein Eye CentersBausch & Lomb Incorporated; Churchhill Communications; Statistics & Data CorporationCompletedTreatment of Ocular Inflammation Associated With Cataract Surgery
Clinical Trials on APP13007, 0.05%
-
Formosa Pharmaceuticals, Inc.CompletedOcular Inflammation and Pain After Cataract SurgeryUnited States
-
Formosa Pharmaceuticals, Inc.CompletedOcular Inflammation and PainUnited States, Puerto Rico
-
LEO PharmaCompletedActinic KeratosisAustralia, Germany
-
Centre Hospitalier Universitaire de NiceCompleted
-
Dermavant Sciences GmbHCompleted
-
LEO PharmaCompletedActinic KeratosisGermany
-
Neal D. Bhatia, MDLEO PharmaCompletedVerruca Vulgaris | Common WartsUnited States
-
Galderma R&DCompleted
-
Creabilis SACompletedPsoriasis VulgarisUnited States, United Kingdom
-
G & W Laboratories Inc.CompletedPlaque PsoriasisUnited States