Efficacy and Safety of APP13007 for Treatment of Inflammation and Pain After Cataract Surgery Including a Corneal Endothelial Cell Sub-study

July 12, 2023 updated by: Formosa Pharmaceuticals, Inc.

A Multicenter, Randomized, Double-Masked, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of APP13007 for the Treatment of Inflammation and Pain After Cataract Surgery, Including a Corneal Endothelial Cell Sub-study

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
370

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Arizona
      • Chandler, Arizona, United States, 85224
        • Arizona Eye Center
      • Mesa, Arizona, United States, 85260
        • Carrot Eye Center
      • Phoenix, Arizona, United States, 85032
        • Cornea and Cataract Consultants of Arizona
    • California
      • Garden Grove, California, United States, 92843
        • Orange County Ophthalmology Medical Group
      • Los Angeles, California, United States, 90013
        • Premiere Practice Management, LLC
      • Murrieta, California, United States, 92562
        • LoBue Laser and Eye Medical Center Inc
      • Newport Beach, California, United States, 92663
        • Visionary Research Institute
      • Petaluma, California, United States, 94954
        • North Bay Eye Associates
      • Torrance, California, United States, 90505
        • Wolstan and Goldberg Eye Associates
      • Westminster, California, United States, 92683
        • Michael K. Tran, MD, Inc.
    • Florida
      • Deerfield Beach, Florida, United States, 33064
        • Rand Eye Institute
      • Fort Myers, Florida, United States, 33901
        • Eye Associates for Fort Myers
      • Jacksonville, Florida, United States, 32204
        • Levenson Eye Associates
      • Tampa, Florida, United States, 33603
        • International Research Center
    • Georgia
      • Albany, Georgia, United States, 31701
        • Dixon Eye Care
      • Morrow, Georgia, United States, 30260
        • Clayton Eye Clinical Research LLC
    • Illinois
      • Hoffman Estates, Illinois, United States, 60169
        • Chicago Cornea Consultants
    • Kansas
      • Overland Park, Kansas, United States, 66213
        • Stiles Eyecare Excellence and Glaucoma Institute, PA
    • Kentucky
      • Louisville, Kentucky, United States, 40206
        • The Eye Care Center
    • Michigan
      • Fraser, Michigan, United States, 48026
        • Fraser Eye Center
    • Missouri
      • Saint Louis, Missouri, United States, 63131
        • Ophthalmology Associates
    • Nevada
      • Las Vegas, Nevada, United States, 89119
        • Wellish Vision Institute
    • New Jersey
      • Palisades Park, New Jersey, United States, 07650
        • Metropolitan Eye Research and Surgery Institute
    • New York
      • Poughkeepsie, New York, United States, 12603
        • Alterman, Modi and Wolter
    • Ohio
      • Cincinnati, Ohio, United States, 45242
        • Cincinnati Eye Institute
    • Pennsylvania
      • Kingston, Pennsylvania, United States, 18704
        • Eye Care Specialists
    • South Carolina
      • Ladson, South Carolina, United States, 29456
        • Carolina Cataract and Laser Center
    • South Dakota
      • Rapid City, South Dakota, United States, 57701
        • Black Hills Regional Eye Institute
    • Texas
      • Houston, Texas, United States, 70025
        • Houston Eye Associates
      • Mission, Texas, United States, 78572
        • DCT-Shah Research Institute LLC dba Discovery Clinical Trials
      • Round Rock, Texas, United States, 78681
        • Round Rock Eye Consultants

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: APP13007 0.05% BID
1 drop APP13007 0.05% twice daily for 14 days to study (operated) eye
Drug: APP13007, 0.05%
APP13007 eye drop, 0.05%
Placebo Comparator: Matching Vehicle Placebo
1 drop matching vehicle placebo twice daily for 14 days to study (operated) eye
Drug: Matching Vehicle Placebo for APP13007, 0.05%
Matching vehicle placebo eye drop

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Participants With ACC Count = 0 in the Operated Study Eye at All Visits From Postoperative Day 8 Through Postoperative Day 15 Without Rescue Medication
Time Frame: Postoperative Day 8 and Postoperative Day 15
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.
Postoperative Day 8 and Postoperative Day 15
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
Time Frame: Postoperative Day 4, Postoperative Day 8 and Postoperative Day 15
Ocular pain is measured in the eye using a subject-reported five-point (0-4) ocular pain grade scale (0 = no pain; 1 = minimal; 2 = mild; 3 = moderate; 4 = severe pain).
Postoperative Day 4, Postoperative Day 8 and Postoperative Day 15
Participants With Treatment-emergent Adverse Events (AEs)
Time Frame: From First dose to Postoperative Day 22 (End of Main Study)
Number of participants with ocular and systemic treatment-emergent AEs.
From First dose to Postoperative Day 22 (End of Main Study)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Participants Using of Anti-inflammatory 'Rescue' Medication Through End-of-Treatment
Time Frame: First dose to Postoperative Day 15
Participants who do not respond to study treatment after randomization are started on anti-inflammatory medication (referred to as 'Rescue' medication). The number of subjects starting 'Rescue' medication is recorded at each study visit
First dose to Postoperative Day 15
Participants With Ocular Pain Grade = 0 in the Operated Study Eye at POD4 Without Rescue Medication
Time Frame: Postoperative Day 4
Ocular pain is measured in the eye using a subject-reported five-point (0-4) ocular pain grade scale (0 = no pain; 4 = severe pain).
Postoperative Day 4
Participants With Ocular Pain Grade = 0 in the Operated Study Eye at POD8 Without Rescue Medication
Time Frame: Postoperative Day 8
Ocular pain is measured in the eye using a subject-reported five-point (0-4) ocular pain grade scale (0 = no pain; 4 = severe pain).
Postoperative Day 8
Participants With Ocular Pain Grade = 0 in the Operated Study Eye at POD15 Without Rescue Medication
Time Frame: Postoperative Day 15
Ocular pain is measured in the eye using a subject-reported five-point (0-4) ocular pain grade scale (0 = no pain; 4 = severe pain).
Postoperative Day 15
Participants With Anterior Chamber Flare (ACF) = 0 in the Operated Study Eye at POD4 Without Rescue Medication
Time Frame: Postoperative Day 4
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).
Postoperative Day 4
Participants With Anterior Chamber Flare (ACF) = 0 in the Operated Study Eye at POD8 Without Rescue Medication
Time Frame: Postoperative Day 8
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).
Postoperative Day 8
Participants With Anterior Chamber Flare (ACF) = 0 in the Operated Study Eye at POD15 Without Rescue Medication
Time Frame: Postoperative Day 15
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).
Postoperative Day 15
Anterior Chamber Cell Grade in the Operated Study Eye - Change From Baseline (POD1 Prior to Dosing) to POD 15
Time Frame: Baseline and Postoperative Day 15
The number of cells in the anterior chamber of the eye are counted using slit-lamp biomicroscopy and the results are reported as number of cells in a 1mm x 1mm area using a 5 point grading scale. ACC Grade 0 = 0 cells, ACC grade 1 = 1-5 cells, ACC grade 2 = 6-15 cells, ACC grade 3 = 16-30 cells, ACC grade 4 = >30 cells
Baseline and Postoperative Day 15
Ocular Pain Grade in the Operated Study Eye - Change From Baseline (POD1 Prior to Dosing) to POD 15
Time Frame: Baseline and Postoperative Day 15
Ocular pain is measured in the eye using a subject-reported five-point (0-4) ocular pain grade scale (0 = no pain; 1 = minimal; 2 = mild; 3 = moderate; 4 = severe pain).
Baseline and Postoperative Day 15
Anterior Chamber Flare (ACF) in the Operated Study Eye - Change From Baseline (POD1 Prior to Dosing) to POD 15
Time Frame: Baseline and Postoperative Day 15
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; 1 = faint; 2 = moderate; 3 = marked; 4 = Intense).
Baseline and Postoperative Day 15
Best Corrected Visual Acuity in the Operated Study Eye - Change From Baseline (POD1 Prior to Dosing) to POD4
Time Frame: Baseline and Postoperative Day 4
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. A logMAR Score is calculated using the letter row on the chart and the number of incorrect letters read by the participant.
Baseline and Postoperative Day 4
Best Corrected Visual Acuity in the Operated Study Eye - Change From Baseline (POD1 Prior to Dosing) to POD8
Time Frame: Baseline and Postoperative Day 8
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. A logMAR Score is calculated using the letter row on the chart and the number of incorrect letters read by the participant.
Baseline and Postoperative Day 8
Best Corrected Visual Acuity in the Operated Study Eye - Change From Baseline (POD1 Prior to Dosing) to POD15
Time Frame: Baseline and Postoperative Day 15
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. A logMAR Score is calculated using the letter row on the chart and the number of incorrect letters read by the participant.
Baseline and Postoperative Day 15
Participants With Anterior Chamber Cell Grade = 0 in the Operated Study Eye at POD8 Without Rescue Medication
Time Frame: Postoperative Day 8
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.ACC Grade 0 = 0 cells, ACC grade 1 = 1-5 cells, ACC grade 2 = 6-15 cells, ACC grade 3 = 16-30 cells, ACC grade 4 = >30 cells.
Postoperative Day 8
Participants With Anterior Chamber Cell Grade = 0 in the Operated Study Eye at POD15 Without Rescue Medication
Time Frame: Postoperative Day 15
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. ACC Grade 0 = 0 cells, ACC grade 1 = 1-5 cells, ACC grade 2 = 6-15 cells, ACC grade 3 = 16-30 cells, ACC grade 4 = >30 cells.
Postoperative Day 15

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Corneal Endothelial Cell Density - Mean Change From Screening to Postoperative Day 85
Time Frame: Screening and Postoperative Day 85
Corneal endothelial cell density in the Operated Study Eye (units: cells/mm2) was measured from the corneal endothelial cell images obtained using a specular microscope.
Screening and Postoperative Day 85

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Formosa Pharmaceuticals, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Chief Medical Officer, AimMax Therapeutics Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 16, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 6, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 6, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 18, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 19, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 23, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 25, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 12, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CPN-302

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

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