A Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of APP13007 to Treat Inflammation and Pain After Cataract Surgery
- Conditions
- Ocular Inflammation and Pain After Cataract Surgery
- Interventions
- Drug: APP13007 Placebo, 0.05%Drug: APP13007, 0.05%Drug: APP13007, 0.1%Drug: APP13007 Placebo, 0.1%
- Registration Number
- NCT04089735
- Lead Sponsor
- Formosa Pharmaceuticals, Inc.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 165
- 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.
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description APP13007 0.05% Placebo twice daily (BID) and once daily (QD) [Part B] APP13007 Placebo, 0.05% 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 0.05% twice daily (BID) [Part A] APP13007, 0.05% 1 drop 0.05% APP13007 twice daily for 21 days to the operated eye APP13007 0.05% twice daily (BID) and once daily (QD) [Part B] APP13007, 0.05% 1 drop 0.05% APP13007 twice daily for 3 days followed by 1 drop once daily for 11 days to the operated eye APP13007 0.1% twice daily (BID) and once daily (QD) [Part B] APP13007, 0.1% 1 drop 0.1% APP13007 twice daily for 3 days followed by 1 drop once daily for 11 days to the operated eye APP13007 0.1% Placebo twice daily (BID) and once daily (QD) [Part B] APP13007 Placebo, 0.1% 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 0.05% Placebo twice daily (BID) [Part A] APP13007 Placebo, 0.05% 1 drop matching vehicle placebo for 0.05% APP13007 twice daily for 21 days to the operated eye
- Primary Outcome Measures
Name Time Method Number of Treatment Emergent Adverse Events 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.
Ocular Pain Grade - Change From Baseline (POD1 Prior to Dosing) to POD15 in the Operated Study Eye 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).
Intraocular Pressure - Change From Baseline (POD1 Prior to Dosing) to End-of-Treatment in the Operated Study Eye 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.
Absolute Anterior Chamber Cell Count - Change From Baseline (POD1 Prior to Dosing) to POD 15 in the Operated Study Eye 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.
Visual Acuity - Change From Baseline (POD1 Prior to Dosing) to End-of Treatment in the Operated Study Eye 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.
- Secondary Outcome Measures
Name Time Method Subjects With Anterior Chamber Cell Count = 0 at POD15 in the Operated Study Eye Without Rescue Medication 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.
Anterior Chamber Flare - Change From Baseline (POD1 Prior to Dosing) to End-of Treatment in the Operated Study Eye 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.
Subjects With Ocular Pain Grade = 0 at POD 15 in the Operated Study Eye Without Rescue Medication 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).
Subjects Using of Anti-inflammatory 'Rescue' Medication Through End-of-Treatment 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.
Trial Locations
- Locations (9)
Cornea and Cataract Consultants of Arizona
🇺🇸Phoenix, Arizona, United States
Martel Eye Medical Group
🇺🇸Rancho Cordova, California, United States
United Medical Research Institute
🇺🇸Inglewood, California, United States
Bowden Eye and Associates
🇺🇸Jacksonville, Florida, United States
Ophthalmology Associates
🇺🇸Saint Louis, Missouri, United States
Levenson Eye Associates
🇺🇸Jacksonville, Florida, United States
Eye Care Specialists
🇺🇸Kingston, Pennsylvania, United States
Keystone Research Ltd.
🇺🇸Austin, Texas, United States
Cataract & Glaucoma Center
🇺🇸El Paso, Texas, United States