Ocular Inflammation and Pain After Cataract SurgeryPhase 3NCT04810962
Efficacy and Safety of APP13007 for Treatment of Inflammation and Pain After Cataract Surgery Including a Corneal Endothelial Cell Sub-study
A Phase 3 study testing APP13007, 0.05% in people with Ocular Inflammation and Pain After Cataract Surgery, run by Formosa Pharmaceuticals, Inc. at 31 sites in United States.
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; 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 After Cataract Surgery
- What is being tested?
- APP13007, 0.05%
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 370 participants
- Where
- 31 sitesUnited States
- Study dates
- 16 Mar 2021to 6 Jul 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
31 sites in 1 country.
31 sites in 1 country
United States31 sites
Dixon Eye Care
Albany, Georgia, 31701
Arizona Eye Center
Chandler, Arizona, 85224
Cincinnati Eye Institute
Cincinnati, Ohio, 45242
Rand Eye Institute
Deerfield Beach, Florida, 33064
Eye Associates for Fort Myers
Fort Myers, Florida, 33901
Fraser Eye Center
Fraser, Michigan, 48026
Orange County Ophthalmology Medical Group
Garden Grove, California, 92843
Chicago Cornea Consultants
Hoffman Estates, Illinois, 60169
Houston Eye Associates
Houston, Texas, 70025
Levenson Eye Associates
Jacksonville, Florida, 32204
Eye Care Specialists
Kingston, Pennsylvania, 18704
Carolina Cataract and Laser Center
Ladson, South Carolina, 29456
Wellish Vision Institute
Las Vegas, Nevada, 89119
Premiere Practice Management, LLC
Los Angeles, California, 90013
The Eye Care Center
Louisville, Kentucky, 40206
Carrot Eye Center
Mesa, Arizona, 85260
DCT-Shah Research Institute LLC dba Discovery Clinical Trials
Mission, Texas, 78572
Clayton Eye Clinical Research LLC
Morrow, Georgia, 30260
LoBue Laser and Eye Medical Center Inc
Murrieta, California, 92562
Visionary Research Institute
Newport Beach, California, 92663
Stiles Eyecare Excellence and Glaucoma Institute, PA
Overland Park, Kansas, 66213
Metropolitan Eye Research and Surgery Institute
Palisades Park, New Jersey, 07650
North Bay Eye Associates
Petaluma, California, 94954
Cornea and Cataract Consultants of Arizona
Phoenix, Arizona, 85032
Alterman, Modi and Wolter
Poughkeepsie, New York, 12603
Black Hills Regional Eye Institute
Rapid City, South Dakota, 57701
Round Rock Eye Consultants
Round Rock, Texas, 78681
Ophthalmology Associates
St Louis, Missouri, 63131
International Research Center
Tampa, Florida, 33603
Wolstan and Goldberg Eye Associates
Torrance, California, 90505
Michael K. Tran, MD, Inc.
Westminster, California, 92683
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, 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.
- Being tested
- APP13007, 0.05%, Matching Vehicle Placebo for APP13007, 0.05%
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 group | Role | What they receive |
|---|---|---|
| APP13007 0.05% BID | Experimental | 1 drop APP13007 0.05% twice daily for 14 days to study (operated) eye Receives: Drug: APP13007, 0.05% |
| Matching Vehicle Placebo | Placebo comparator | 1 drop matching vehicle placebo 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.
Participants With ACC Count = 0 in the Operated Study Eye 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
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
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).
Measured: Postoperative Day 4, Postoperative Day 8 and Postoperative Day 15
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 (End of Main Study)
Secondary outcomes (15)
Participants With Anterior Chamber Cell Grade = 0 in the Operated Study Eye 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
Participants With Anterior Chamber Cell Grade = 0 in the Operated Study Eye 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
Participants With Ocular Pain Grade = 0 in the Operated Study Eye at POD4 Without Rescue Medication
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).
Measured: Postoperative Day 4
Participants With Ocular Pain Grade = 0 in the Operated Study Eye at POD8 Without Rescue Medication
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).
Measured: Postoperative Day 8
Participants With Ocular Pain Grade = 0 in the Operated Study Eye at POD15 Without Rescue Medication
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).
Measured: Postoperative Day 15
Participants With Anterior Chamber Flare (ACF) = 0 in the Operated Study Eye 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
Participants With Anterior Chamber Flare (ACF) = 0 in the Operated Study Eye 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
Participants With Anterior Chamber Flare (ACF) = 0 in the Operated Study Eye 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
Anterior Chamber Cell Grade in the Operated Study Eye - 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
Ocular Pain Grade in the Operated Study Eye - Change From Baseline (POD1 Prior to Dosing) to POD 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).
Measured: Baseline and Postoperative Day 15
Anterior Chamber Flare (ACF) in the Operated Study Eye - 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; 1 = faint; 2 = moderate; 3 = marked; 4 = Intense).
Measured: Baseline and Postoperative Day 15
Best Corrected Visual Acuity in the Operated Study Eye - 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
Best Corrected Visual Acuity in the Operated Study Eye - 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
Best Corrected Visual Acuity in the Operated Study Eye - 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
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.
- First posted23 Mar 2021
- Study start16 Mar 2021
- Primary completion6 Jul 2022
- Study completion6 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Ocular Inflammation and Pain After Cataract SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 370 participants (actual)
Sponsor and investigators
- Lead sponsor
- Formosa Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Chief Medical Officer, Study director, AimMax Therapeutics Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04810962
- Sponsor's protocol ID
- CPN-302
- Status last verified
- Jul 2023
- First submitted
- 18 Mar 2021
- Last updated
- 25 Jul 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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, Including a Corneal Endothelial Cell Sub-study
- ClinicalTrials.gov ID
- NCT04810962
- Acronym / sponsor ID
- CPN-302
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 370 participants (actual)
- Lead sponsor
- Formosa Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- 16 Mar 2021 (actual)
- Primary completion
- 6 Jul 2022 (actual)
- Study completion
- 6 Jul 2022 (actual)
- First posted
- 23 Mar 2021 (actual)
- Results
- Posted 7 Jul 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| APP13007 0.05% BID | Experimental | Drug: APP13007, 0.05%1 drop APP13007 0.05% twice daily for 14 days to study (operated) eye |
| Matching Vehicle Placebo | Placebo comparator | Drug: Matching Vehicle Placebo for APP13007, 0.05%1 drop matching vehicle placebo twice daily for 14 days to study (operated) eye |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| APP13007, 0.05%APP13007 eye drop, 0.05% | Drug | APP13007 0.05% BID |
| Matching Vehicle Placebo for APP13007, 0.05%Matching vehicle placebo eye drop | Drug | Matching Vehicle Placebo |
Primary outcome
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.
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).
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.
15 secondary outcomes
Participants With Anterior Chamber Cell Grade = 0 in the Operated Study Eye at POD8 Without Rescue Medication
Time frame: 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
Participants With Ocular Pain Grade = 0 in the Operated Study Eye at POD4 Without Rescue Medication
Time frame: Postoperative Day 4
Participants With Ocular Pain Grade = 0 in the Operated Study Eye at POD8 Without Rescue Medication
Time frame: Postoperative Day 8
Participants With Ocular Pain Grade = 0 in the Operated Study Eye at POD15 Without Rescue Medication
Time frame: 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
Participants With Anterior Chamber Flare (ACF) = 0 in the Operated Study Eye at POD8 Without Rescue Medication
Time frame: 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
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
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
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
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
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
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
Participants Using of Anti-inflammatory 'Rescue' Medication Through End-of-Treatment
Time frame: First dose to Postoperative Day 15
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chief Medical Officer study director
AimMax Therapeutics Inc.
31 sites in 1 country: see every site and its status.
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 After Cataract Surgery, run by Formosa Pharmaceuticals, Inc. at 31 sites in United States.
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 25 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 31 sites in United States. 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 7 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 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 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?
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 25 Jul 2023.