Phase 3
Completed N=370
Efficacy and Safety of APP13007 for Treatment of Inflammation and Pain After Cataract Surgery Including a Corneal Endothelial Cell Sub-study
Ocular Inflammation and Pain After Cataract Surgery
Source: ClinicalTrials.gov NCT04810962 ↗
Enrolled (actual)
370
Serious AEs
1.4%
Results posted
Jul 2023
Primary outcomePrimary: Participants With ACC Count = 0 in the Operated Study Eye at All Visits From Postoperative Day 8 Through Postoperative Day 15 Without Rescue Medication — 49; 16 Participants — p=<0.001
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
This Phase 3 study will evaluate APP13007 in comparison to the matching vehicle placebo in a randomized, parallel-group, double-masked fashion. The subjects will have undergone routine cataract surgery on Day 0 of the study and will be assessed the next day (Post-operative Day; POD1) after uncomplicated surgery for eligibility for randomization to study treatment. The study comprises the Main Study and the Endothelial Cell Sub-study.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Participants With ACC Count = 0 in the Operated Study Eye at All Visits From Postoperative Day 8 Through Postoperative Day 15 Without Rescue Medication |
49; 16 | <0.001 sig |
| PRIMARY Participants With Ocular Pain Grade = 0 in the Operated Study Eye at All Visits From Postoperative Day 4 Through Postoperative Day 15 Without Rescue Medication |
139; 60 | <0.001 sig |
| PRIMARY Participants With Treatment-emergent Adverse Events (AEs) |
47; 48 | — |
| SECONDARY Participants With Anterior Chamber Cell Grade = 0 in the Operated Study Eye at POD8 Without Rescue Medication |
55; 24 | <0.001 sig |
| SECONDARY Participants With Anterior Chamber Cell Grade = 0 in the Operated Study Eye at POD15 Without Rescue Medication |
107; 35 | <0.001 sig |
| SECONDARY Participants With Ocular Pain Grade = 0 in the Operated Study Eye at POD4 Without Rescue Medication |
158; 95 | <0.001 sig |
| SECONDARY Participants With Ocular Pain Grade = 0 in the Operated Study Eye at POD8 Without Rescue Medication |
161; 86 | <0.001 sig |
| SECONDARY Participants With Ocular Pain Grade = 0 in the Operated Study Eye at POD15 Without Rescue Medication |
160; 92 | <0.001 sig |
| SECONDARY Participants With Anterior Chamber Flare (ACF) = 0 in the Operated Study Eye at POD4 Without Rescue Medication |
132; 89 | <0.001 sig |
| SECONDARY Participants With Anterior Chamber Flare (ACF) = 0 in the Operated Study Eye at POD8 Without Rescue Medication |
155; 90 | <0.001 sig |
| SECONDARY Participants With Anterior Chamber Flare (ACF) = 0 in the Operated Study Eye at POD15 Without Rescue Medication |
159; 79 | <0.001 sig |
| SECONDARY Anterior Chamber Cell Grade in the Operated Study Eye - Change From Baseline (POD1 Prior to Dosing) to POD 15 |
-2.1; -1.0 | <0.001 sig |
| SECONDARY Ocular Pain Grade in the Operated Study Eye - Change From Baseline (POD1 Prior to Dosing) to POD 15 |
-0.6; -0.1 | <0.001 sig |
| SECONDARY Anterior Chamber Flare (ACF) in the Operated Study Eye - Change From Baseline (POD1 Prior to Dosing) to POD 15 |
-0.6; -0.2 | <0.001 sig |
| SECONDARY Best Corrected Visual Acuity in the Operated Study Eye - Change From Baseline (POD1 Prior to Dosing) to POD4 |
-0.08; -0.03 | <0.001 sig |
| SECONDARY Best Corrected Visual Acuity in the Operated Study Eye - Change From Baseline (POD1 Prior to Dosing) to POD8 |
-0.11; -0.03 | <0.001 sig |
| SECONDARY Best Corrected Visual Acuity in the Operated Study Eye - Change From Baseline (POD1 Prior to Dosing) to POD15 |
-0.10; -0.02 | <0.001 sig |
| SECONDARY Participants Using of Anti-inflammatory 'Rescue' Medication Through End-of-Treatment |
13; 71 | <0.001 sig |
Eligibility Criteria
Inclusion Criteria
- Patients 18 years of age or older expected to undergo unilateral uncomplicated cataract extraction via phacoemulsification and posterior chamber intraocular lens implantation in one eye.
- Have a pin-hole corrected visual acuity without other correction of ≤ 1.3 logarithm of the minimum angle of resolution (logMAR) in the study eye to be operated and contralateral eye as measured using an Early Treatment Diabetic Retinopathy Study (ETDRS) chart at Visit 1.
- Willing and able to comply with study requirements and visit schedule.
- Provide signed and dated informed consent.
Exclusion Criteria
- Have a known sensitivity or allergy to clobetasol propionate, corticosteroids, or any of the study medication's components including benzalkonium chloride and soybean lecithin or any routine medication required during cataract surgery or for the conduct of study procedures
- Have an ACC count > 0 or any evidence of intraocular inflammation (e.g., flare) in either eye at the Screening visit
- Have a Grade > 0 on the Ocular Pain Assessment in either eye at the Screening visit
Note: Other inclusion/exclusion criteria apply.
Data sourced from ClinicalTrials.gov (NCT04810962). 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.