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A Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of APP13007 to Treat Inflammation and Pain After Cataract Surgery

NCT04089735 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 165

Last updated 2023-06-27

Study results available
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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.

Conditions

  • Ocular Inflammation and Pain After Cataract Surgery

Interventions

DRUG

APP13007, 0.05%

APP13007 eye drop, 0.05%

DRUG

APP13007, 0.1%

APP13007 eye drop, 0.1%

DRUG

APP13007 Placebo, 0.05%

APP13007 placebo eyedrop, 0.05%

DRUG

APP13007 Placebo, 0.1%

APP13007 placebo eyedrop, 0.1%

Sponsors & Collaborators

  • Formosa Pharmaceuticals, Inc.

    lead INDUSTRY

Principal Investigators

  • Chief Medical Officer · AimMax Therapeutics Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-08-13
Primary Completion
2020-04-07
Completion
2020-04-07
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04089735 on ClinicalTrials.gov