Title
A Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of APP13007 to Treat Inflammation and Pain After Cataract Surgery
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
Phase
Phase 2Lead Sponsor
Formosa Pharmaceuticals, Inc.Study Type
InterventionalStatus
Completed Results PostedIndication/Condition
Pain ...Intervention/Treatment
APP13007, 0.05% APP13007, 0.1% APP13007 Placebo, 0.05% APP13007 Placebo, 0.1%Study Participants
165This 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.
APP13007 eye drop, 0.05%
APP13007 eye drop, 0.1%
APP13007 placebo eyedrop, 0.05%
APP13007 placebo eyedrop, 0.1%
1 drop 0.05% APP13007 twice daily for 21 days to the operated eye
1 drop matching vehicle placebo for 0.05% APP13007 twice daily for 21 days to the operated eye
1 drop 0.05% APP13007 twice daily for 3 days followed by 1 drop once daily for 11 days to the operated eye
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
1 drop 0.1% APP13007 twice daily for 3 days followed by 1 drop once daily for 11 days to the operated eye
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
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.
| Event Type | Organ System | Event Term | APP13007 0.05% Twice Daily (BID) | APP13007 0.05% Placebo Twice Daily (BID) | APP13007 0.05% Twice Daily (BID) and Once Daily (QD) | APP13007 0.05% Placebo Twice Daily (BID) and Once Daily (QD) | APP13007 0.1% Twice Daily (BID) and Once Daily (QD) | APP13007 0.1% Placebo Twice Daily (BID) and Once Daily (QD) |
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Number of treatment emergent adverse events and number of participants.
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.
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.
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.
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).
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.
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).
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 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.
