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APP13007, 0.05% for Ocular Inflammation and Pain

Phase 3
Waitlist Available
Research Sponsored by Formosa Pharmaceuticals, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up postoperative day 4, postoperative day 8 and postoperative day 15
Awards & highlights

Study Summary

This study is evaluating whether a drug may help improve vision for individuals who have had cataract surgery.

Eligible Conditions
  • Ocular Inflammation and Pain

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~postoperative day 4, postoperative day 8 and postoperative day 15
This trial's timeline: 3 weeks for screening, Varies for treatment, and postoperative day 4, postoperative day 8 and postoperative day 15 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Participants With ACC Count = 0 in the Operated Study Eye at All Visits From Postoperative Day 8 Through Postoperative Day 15 Without Rescue Medication
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
Participants With Treatment-emergent Adverse Events (AEs)
Secondary outcome measures
Anterior Chamber Cell Grade in the Operated Study Eye - Change From Baseline (POD1 Prior to Dosing) to POD 15
Anterior Chamber Flare (ACF) in the Operated Study Eye - Change From Baseline (POD1 Prior to Dosing) to POD 15
Best Corrected Visual Acuity in the Operated Study Eye - Change From Baseline (POD1 Prior to Dosing) to POD15
+12 more
Other outcome measures
Corneal Endothelial Cell Density - Mean Change From Screening to Postoperative Day 85

Side effects data

From 2022 Phase 3 trial • 378 Patients • NCT04739709
2%
Corneal oedema
100%
80%
60%
40%
20%
0%
Study treatment Arm
APP13007 0.05% BID
Matching Vehicle Placebo

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: APP13007 0.05% BIDExperimental Treatment1 Intervention
1 drop APP13007 0.05% twice daily for 14 days to study (operated) eye
Group II: Matching Vehicle PlaceboPlacebo Group1 Intervention
1 drop matching vehicle placebo twice daily for 14 days to study (operated) eye
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
APP13007, 0.05%
2021
Completed Phase 3
~920

Find a Location

Who is running the clinical trial?

Formosa Pharmaceuticals, Inc.Lead Sponsor
2 Previous Clinical Trials
543 Total Patients Enrolled
1 Trials studying Ocular Inflammation and Pain
378 Patients Enrolled for Ocular Inflammation and Pain
Chief Medical OfficerStudy DirectorAimMax Therapeutics Inc.
122 Previous Clinical Trials
21,154 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Efficacy and Safety of APP13007 for Treatment of Inflammation and Pain After Cataract Surgery Including a Corneal Endothelial Cell Sub-study
2021. "Efficacy and Safety of APP13007 for Treatment of Inflammation and Pain After Cataract Surgery Including a Corneal Endothelial Cell Sub-study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04810962.
~91 spots leftby Apr 2025
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