A Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of APP13007 to Treat Inflammation and Pain After Cataract Surgery
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: APP13007 0.05% twice daily (BID) 1 drop 0.05% APP13007 twice daily for 21 days to the operated eye |
Drug: APP13007, 0.05%
APP13007 eye drop, 0.05%
|
| Experimental: APP13007 0.05% Placebo twice daily (BID) 1 drop matching vehicle placebo for 0.05% APP13007 twice daily for 21 days to the operated eye |
Drug: APP13007 Placebo, 0.05%
APP13007 eye drop, placebo 0.05%
|
| Experimental: APP13007 0.05% twice daily (BID) and once daily (QD) 1 drop 0.05% APP13007 twice daily followed by 1 drop once daily to the operated eye |
Drug: APP13007, 0.05%
APP13007 eye drop, 0.05%
|
| Experimental: APP13007 0.05% Placebo twice daily (BID) and once daily (QD) 1 drop matching vehicle placebo for 0.05% APP13007 twice daily followed by 1 drop once daily to the operated eye |
Drug: APP13007 Placebo, 0.05%
APP13007 eye drop, placebo 0.05%
|
| Experimental: APP13007 0.1% twice daily (BID) and once daily (QD) 1 drop 0.1% APP13007 twice daily followed by 1 drop once daily to the operated eye |
Drug: APP13007, 0.1%
APP13007 eye drop, 0.1%
|
| Experimental: APP13007 0.1% Placebo twice daily (BID) and once daily (QD) 1 drop matching vehicle placebo for 0.1% APP13007 twice daily followed by 1 drop once daily to the operated eye |
Drug: APP13007 Placebo, 0.1%
APP13007 eye drop, placebo 0.1%
|
Outcome Measures
Primary Outcome Measures
- Incidence of Adverse Events [Post-operative Day 28 (Part A) or Day 22 (Part B)]
Incidence of treatment emergent adverse events at each study visit.
- Ocular Anatomy [Post-operative Day 28 (Part A) or Day 22 (Part B)]
Ocular anatomy is routinely assessed using slit-lamp biomicroscopy and dilated indirect ophthalmoscopy. Ocular tissues are examined at each study visit and any anatomical abnormalities are recorded using standard medical descriptive terminology.
- Intraocular Pressure [Post-operative Day 28 (Part A) or Day 22 (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.
- Laboratory Blood Chemistry Parameters [Post-operative Day 28 (Part A)]
Laboratory chemistry parameters are measured using automated equipment that is used routinely in clinical practice for the measurement of blood electrolytes, proteins, hormones and metabolites and results are reported using standard biochemical units.
- Laboratory Blood Hematology Parameters [Post-operative Day 28 (Part A)]
Laboratory hematology parameters are measured using automated equipment that is used routinely in clinical practice for the measurement of blood cells and hemoglobin and results are reported using standard hematological units.
- Absolute Anterior Chamber Cell Count [Post-operative Day 28 (Part A) or Day 22 (Part B)]
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 [Post-operative Day 28 (Part A) or Day 22 (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.
- Ocular Pain Grade [Post-operative Day 28 (Part A) or Day 22 (Part B)]
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).
Secondary Outcome Measures
- Change from Baseline of Anterior Chamber Cell Count [Post-operative Day 28 (Part A) or Day 22 (Part B)]
The number of cells in a 1mm x 1mm area in the anterior chamber of the eye are counted using slit-lamp biomicroscopy at each study visit. The change from baseline is calculated by subtracting the pretreatment measurement from the value at each visit.
- Anterior Chamber Flare [Post-operative Day 28 (Part A) or Day 22 (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.
- Use of Anti-inflammatory 'Rescue' Medication [Post-operative Day 28 (Part A) or Day 22 (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 are recorded at each study visit.
Eligibility Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Cornea and Cataract Consultants of Arizona | Phoenix | Arizona | United States | 85032 |
| 2 | United Medical Research Institute | Inglewood | California | United States | 90301 |
| 3 | Martel Eye Medical Group | Rancho Cordova | California | United States | 95670 |
| 4 | Levenson Eye Associates | Jacksonville | Florida | United States | 32204 |
| 5 | Bowden Eye and Associates | Jacksonville | Florida | United States | 32256 |
| 6 | Ophthalmology Associates | Saint Louis | Missouri | United States | 63131 |
| 7 | Eye Care Specialists | Kingston | Pennsylvania | United States | 18704 |
| 8 | Keystone Research Ltd. | Austin | Texas | United States | 78731 |
| 9 | Cataract & Glaucoma Center | El Paso | Texas | United States | 79902 |
Sponsors and Collaborators
- Formosa Pharmaceuticals, Inc.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CPN-201