Phase 2
Completed N=132
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
Source: ClinicalTrials.gov NCT04089735 ↗
Enrolled (actual)
132
Serious AEs
0.0%
Results posted
Jun 2023
Primary outcomePrimary: Number of Treatment Emergent Adverse Events — 4; 7; 3; 8 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Treatment Emergent Adverse Events |
4; 7; 3; 8; 6; 3 | — |
| PRIMARY Intraocular Pressure - Change From Baseline (POD1 Prior to Dosing) to End-of-Treatment in the Operated Study Eye |
1.1; -2.3; -2.37; -2.38; -1.28; -1.00 | — |
| PRIMARY Absolute Anterior Chamber Cell Count - Change From Baseline (POD1 Prior to Dosing) to POD 15 in the Operated Study Eye |
-16.64; -9.24; -11.48; -5.67; -11.90; -7.43 | — |
| PRIMARY Visual Acuity - Change From Baseline (POD1 Prior to Dosing) to End-of Treatment in the Operated Study Eye |
-0.179; -0.073; -0.106; -0.024; -0.130; -0.025 | — |
| PRIMARY Ocular Pain Grade - Change From Baseline (POD1 Prior to Dosing) to POD15 in the Operated Study Eye |
-0.8; -0.4; -1.1; -0.4; -0.6; -0.3 | — |
| SECONDARY Subjects With Anterior Chamber Cell Count = 0 at POD15 in the Operated Study Eye Without Rescue Medication |
15; 8; 10; 7; 13; 8 | — |
| SECONDARY Subjects With Ocular Pain Grade = 0 at POD 15 in the Operated Study Eye Without Rescue Medication |
21; 16; 20; 16; 19; 15 | — |
| SECONDARY Anterior Chamber Flare - Change From Baseline (POD1 Prior to Dosing) to End-of Treatment in the Operated Study Eye |
-1.05; -0.39; -0.77; -0.48; -0.64; -0.10 | — |
| SECONDARY Subjects Using of Anti-inflammatory 'Rescue' Medication Through End-of-Treatment |
0; 3; 0; 5; 0; 5 | — |
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT04089735). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.