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Ocular Inflammation and PainPhase 3NCT04739709

Efficacy and Safety of APP13007 for Treatment of Inflammation and Pain After Cataract Surgery

A Phase 3 study testing APP13007, 0.05% in people with Ocular Inflammation and Pain, run by Formosa Pharmaceuticals, Inc. at 35 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 1; POD1) after uncomplicated surgery for… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Ocular Inflammation and Pain
What is being tested?
APP13007, 0.05%
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
378 participants
Where
35 sitesin 2 countries
Study dates
11 Jan 2021to 17 Mar 2022
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

35 sites in 2 countries.

35 sites in 2 countries

United States34 sites

  • Keystone Research Ltd.

    Austin, Texas, 78731

  • Retina Research Center, PLLC

    Austin, Texas, 78750

  • Midwest Cornea Associates, LLC

    Carmel, Indiana, 46290

  • Jacksoneye SC

    Columbus, Illinois, 60046

  • Eye Physicians, LLC

    Columbus, Ohio, 43215

  • Global Research Management

    Glendale, California, 91204

  • Icon Eye Care

    Grand Junction, Colorado, 81501

  • Inland Eye Specialists

    Hemet, California, 92545

  • NV Eye Surgery

    Henderson, Nevada, 89052

  • Houston Eye Associates

    Houston, Texas, 77008

  • Advanced Laser Vision and Surgical Institute

    Houston, Texas, 77034

  • Levenson Eye Associates

    Jacksonville, Florida, 32204

  • Silverstein Eye Centers, PC

    Kansas City, Missouri, 64133

  • Lake Travis Eye and Laser Center

    Lakeway, Texas, 78738

  • Center For Sight

    Las Vegas, Nevada, 89145

  • SoCal Eye Physicians and Associates

    Long Beach, California, 90805

  • Senior Health Services

    Louisville, Kentucky, 40220

  • North Valley Eye Medical Group, Inc.

    Mission Hills, California, 91345

  • LoBue Laser and Eye Medical Center, Inc.

    Murrieta, California, 92562

  • Raymond Fong, MD, PC

    New York, New York, 10013

  • Pendleton Eye Center

    Oceanside, California, 92056

  • International Eye Associates, PA

    Ormond Beach, Florida, 32174

  • Martel Eye Medical Group

    Rancho Cordova, California, 95670

  • Shasta Eye Medical Group, Inc.

    Redding, California, 96001

  • Coastal Research Associates, LLC

    Roswell, Georgia, 30076

  • Stacy R. Smith, MD, PC

    Salt Lake City, Utah, 84117

  • R and R Eye Research, LLC

    San Antonio, Texas, 78229

  • San Antonio Eye Center

    San Antonio, Texas, 78238

  • Schwartz Laser Eye Center

    Scottsdale, Arizona, 85260

  • Newsom Eye and Laser Center

    Sebring, Florida, 33870

  • Carolina Eye Associates

    Southern Pines, North Carolina, 28387

  • Ophthalmology Consultants, Ltd.

    St Louis, Missouri, 63131

  • Comprehensive Eye Care, Ltd.

    Washington, Missouri, 63090

  • Bucci Laser Vision Institute

    Wilkes-Barre, Pennsylvania, 18702

Other trials in United States

Puerto Rico1 site

  • Centro Oftalmologico Metropolitano

    San Juan, 00921

Other trials in Puerto Rico

About this study

Official title: 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

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 1; POD1) after uncomplicated surgery for eligibility for randomization to study treatment.

Being tested
APP13007, 0.05%, Matching Vehicle Placebo for APP13007, 0.05%
Medical subject headings
Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • APP13007, 0.05%Drug

    APP13007 eye drop, 0.05%

  • Matching Vehicle Placebo for APP13007, 0.05%Drug

    Matching vehicle placebo eye drop

Study groups in NCT04739709
Study groupRoleWhat they receive
APP13007 0.05% BIDExperimental1 drop APP13007 0.05% twice daily for 14 days to study (operated) eye
Receives: Drug: APP13007, 0.05%
Matching Vehicle PlaceboPlacebo comparator1 drop matching vehicle place twice daily for 14 days to study (operated) eye
Receives: Drug: Matching Vehicle Placebo for APP13007, 0.05%

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Participants With ACC Count = 0 at All Visits From Postoperative Day 8 Through Postoperative Day 15 Without Rescue Medication

    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.

    Measured: Postoperative Day 8 and Postoperative Day 15

  2. Participants With Ocular Pain Grade = 0 at All Visits From Postoperative Day 4 Through Postoperative Day 15 Without Rescue Medication

    Ocular pain is measured in each 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).

    Measured: Postoperative Day 4, Postoperative Day 8 and Postoperative Day 15

  3. Participants With Treatment-emergent Adverse Events (AEs)

    Number of participants with ocular and systemic treatment-emergent AEs.

    Measured: From First dose to Postoperative Day 22

Secondary outcomes (15)

  1. Participants With Anterior Chamber Cell Grade = 0 at POD8 Without Rescue Medication

    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

    Measured: Postoperative Day 8

  2. Participants With Anterior Chamber Cell Grade = 0 at POD15 Without Rescue Medication

    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

    Measured: Postoperative Day 15

  3. Participants With Ocular Pain Grade = 0 at POD4 Without Rescue Medication

    Ocular pain is measured in each eye using a subject-reported five-point (0-4) ocular pain grade scale (0 = no pain; 4 = severe pain).

    Measured: Postoperative Day 4

  4. Participants With Ocular Pain Grade = 0 at POD8 Without Rescue Medication

    Ocular pain is measured in each eye using a subject-reported five-point (0-4) ocular pain grade scale (0 = no pain; 4 = severe pain).

    Measured: Postoperative Day 8

  5. Participants With Ocular Pain Grade = 0 at POD15 Without Rescue Medication

    Ocular pain is measured in each eye using a subject-reported five-point (0-4) ocular pain grade scale (0 = no pain; 4 = severe pain).

    Measured: Postoperative Day 15

  6. Participants With Anterior Chamber Flare (ACF) = 0 at POD4 Without Rescue Medication

    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).

    Measured: Postoperative Day 4

  7. Participants With Anterior Chamber Flare (ACF) = 0 at POD8 Without Rescue Medication

    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).

    Measured: Postoperative Day 8

  8. Participants With Anterior Chamber Flare (ACF) = 0 at POD15 Without Rescue Medication

    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).

    Measured: Postoperative Day 15

  9. Anterior Chamber Cell Grade - Change From Baseline (POD1 Prior to Dosing) to POD 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

    Measured: Baseline and Postoperative Day 15

  10. Ocular Pain Grade - Change From Baseline (POD1 Prior to Dosing) to POD 15

    Ocular pain is measured in each eye using a subject-reported five-point (0-4) ocular pain grade scale (0 = no pain; 4 = severe pain).

    Measured: Baseline and Postoperative Day 15

  11. Anterior Chamber Flare (ACF) - Change From Baseline (POD1 Prior to Dosing) to POD 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).

    Measured: Baseline and Postoperative Day 15

  12. Best Corrected Visual Acuity - Change From Baseline (POD1 Prior to Dosing) to POD4

    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.

    Measured: Baseline and Postoperative Day 4

  13. Best Corrected Visual Acuity - Change From Baseline (POD1 Prior to Dosing) to POD8

    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.

    Measured: Baseline and Postoperative Day 8

  14. Best Corrected Visual Acuity - Change From Baseline (POD1 Prior to Dosing) to POD15

    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.

    Measured: Baseline and Postoperative Day 15

  15. Participants Using of Anti-inflammatory 'Rescue' Medication Through End-of-Treatment

    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

    Measured: First dose to Postoperative Day 15

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Feb 2021
  2. Study start11 Jan 2021
  3. Primary completion17 Mar 2022
  4. Study completion17 Mar 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
378 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04739709
Sponsor's protocol ID
CPN-301
Status last verified
Jul 2023
First submitted
26 Jan 2021
Last updated
20 Jul 2023
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing APP13007, 0.05% in people with Ocular Inflammation and Pain, run by Formosa Pharmaceuticals, Inc. at 35 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 35 sites in United States, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 5 Jul 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Participants With ACC Count = 0 at All Visits From Postoperative Day 8 Through Postoperative Day 15 Without Rescue Medication (time frame: Postoperative Day 8 and Postoperative Day 15). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04739709.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2023.

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