Ocular Inflammation and Pain After Cataract SurgeryPhase 2NCT04089735
A Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of APP13007 to Treat Inflammation and Pain After Cataract Surgery
A Phase 2 study testing APP13007, 0.05% and APP13007, 0.1% in people with Ocular Inflammation and Pain After Cataract Surgery, run by Formosa Pharmaceuticals, Inc. at 9 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Ocular Inflammation and Pain After Cataract Surgery
- What is being tested?
- APP13007, 0.05% and APP13007, 0.1%
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 165 participants
- Where
- 9 sitesUnited States
- Study dates
- 13 Aug 2019to 7 Apr 2020
- Phase
- Phase 2
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Expected to undergo unilateral uncomplicated cataract extraction via phacoemulsification and posterior chamber intraocular lens implantation in one eye.
- In Investigator's opinion, have Early Treatment Diabetic Retinopathy Study estimated potential of 0.7 (20/100) or better in study eye.
- Have > 10 and ≤ 30 cells in anterior chamber.
- Have an intraocular pressure ≤ 30 mmHg.
Who cannot join
- Have an anterior chamber cell count > 0 or any evidence of intraocular inflammation.
- Have a score > 0 on Ocular Pain Assessment in either eye.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
Keystone Research Ltd.
Austin, Texas, 78731
Cataract & Glaucoma Center
El Paso, Texas, 79902
United Medical Research Institute
Inglewood, California, 90301
Levenson Eye Associates
Jacksonville, Florida, 32204
Bowden Eye and Associates
Jacksonville, Florida, 32256
Eye Care Specialists
Kingston, Pennsylvania, 18704
Cornea and Cataract Consultants of Arizona
Phoenix, Arizona, 85032
Martel Eye Medical Group
Rancho Cordova, California, 95670
Ophthalmology Associates
St Louis, Missouri, 63131
About this study
Official title: A Multicenter, Randomized, Double-Masked, Two-Part, Placebo-Controlled Phase 2A Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of APP13007 for the Treatment of Inflammation and Pain After Cataract Surgery
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.
- Being tested
- APP13007, 0.05%, APP13007, 0.1%, APP13007 Placebo, 0.05%, APP13007 Placebo, 0.1%
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%
APP13007, 0.1%Drug
APP13007 eye drop, 0.1%
APP13007 Placebo, 0.05%Drug
APP13007 placebo eyedrop, 0.05%
APP13007 Placebo, 0.1%Drug
APP13007 placebo eyedrop, 0.1%
| Study group | Role | What they receive |
|---|---|---|
| APP13007 0.05% twice daily (BID) [Part A] | Experimental | 1 drop 0.05% APP13007 twice daily for 21 days to the operated eye Receives: Drug: APP13007, 0.05% |
| APP13007 0.05% Placebo twice daily (BID) [Part A] | Experimental | 1 drop matching vehicle placebo for 0.05% APP13007 twice daily for 21 days to the operated eye Receives: Drug: APP13007 Placebo, 0.05% |
| APP13007 0.05% twice daily (BID) and once daily (QD) [Part B] | Experimental | 1 drop 0.05% APP13007 twice daily for 3 days followed by 1 drop once daily for 11 days to the operated eye Receives: Drug: APP13007, 0.05% |
| APP13007 0.05% Placebo twice daily (BID) and once daily (QD) [Part B] | Experimental | 1 drop matching vehicle placebo for 0.05% APP13007 twice daily for 3 days followed by 1 drop once daily for 11 days to the operated eye Receives: Drug: APP13007 Placebo, 0.05% |
| APP13007 0.1% twice daily (BID) and once daily (QD) [Part B] | Experimental | 1 drop 0.1% APP13007 twice daily for 3 days followed by 1 drop once daily for 11 days to the operated eye Receives: Drug: APP13007, 0.1% |
| APP13007 0.1% Placebo twice daily (BID) and once daily (QD) [Part B] | Experimental | 1 drop matching vehicle placebo for 0.1% APP13007 twice daily for 3 days followed by 1 drop once daily for 11 days to the operated eye Receives: Drug: APP13007 Placebo, 0.1% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Treatment Emergent Adverse Events
Number of treatment emergent adverse events and number of participants.
Measured: From First dose to Post-operative Day 28 (Part A) or Day 22 (Part B)
Intraocular Pressure - Change From Baseline (POD1 Prior to Dosing) to End-of-Treatment in the Operated Study Eye
Intraocular pressure is measured in mm Hg at each study visit with a Goldmann applanation tonometer. The change from baseline is calculated by subtracting the pretreatment measurement value from the value at each visit.
Measured: Baseline and Post-operative Day 22 (Part A) or Day 15 (Part B)
Absolute Anterior Chamber Cell Count - Change From Baseline (POD1 Prior to Dosing) to POD 15 in the Operated Study Eye
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: Baseline and Post-operative Day 15
Visual Acuity - Change From Baseline (POD1 Prior to Dosing) to End-of Treatment in the Operated Study Eye
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 number of incorrect letters.
Measured: Baseline and Post-operative Day 22 (Part A) or Day 15 (Part B)
Ocular Pain Grade - Change From Baseline (POD1 Prior to Dosing) to POD15 in the Operated Study Eye
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 Post-operative Day 15
Secondary outcomes (4)
Subjects With Anterior Chamber Cell Count = 0 at POD15 in the Operated Study Eye 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: Post-operative Day 15
Subjects With Ocular Pain Grade = 0 at POD 15 in the Operated Study Eye 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: Post-operative Day 15
Anterior Chamber Flare - Change From Baseline (POD1 Prior to Dosing) to End-of Treatment in the Operated Study Eye
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). The change from baseline is calculated by subtracting the pretreatment measurement value from the value at each visit.
Measured: Baseline and Post-operative Day 22 (Part A) or Day 15 (Part B)
Subjects Using of Anti-inflammatory 'Rescue' Medication Through End-of-Treatment
Subjects who do not respond to study treatment after randomization (anterior chamber cell count > 30 cells or an increase in anterior chamber cell count by > 15 cells from pre-dose baseline or ≥ 2 grade of increase in anterior chamber flare from pre-dose baseline) 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 Post-operative Day 22 (Part A) or Day 15 (Part B)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2019
- Study start13 Aug 2019
- Primary completion7 Apr 2020
- Study completion7 Apr 2020
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.
- Publications (1)Papers the sponsor has linked to this study.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 165 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
- NCT04089735
- Sponsor's protocol ID
- CPN-201
- Status last verified
- Jun 2023
- First submitted
- 28 Aug 2019
- Last updated
- 27 Jun 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Levenson J, Walters TR, Martel J, Wang L, Nunez DJ. Dose-selection study of clobetasol propionate ophthalmic suspension that evaluated inflammation and pain after cataract surgery. J Cataract Refract Surg. 2026 May 1;52(5):444-451. doi: 10.1097/j.jcrs.0000000000001845.
PubMed 41329923
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-Masked, Two-Part, Placebo-Controlled Phase 2A Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of APP13007 for the Treatment of Inflammation and Pain After Cataract Surgery
- ClinicalTrials.gov ID
- NCT04089735
- Acronym / sponsor ID
- CPN-201
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 165 participants (actual)
- Lead sponsor
- Formosa Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- 13 Aug 2019 (actual)
- Primary completion
- 7 Apr 2020 (actual)
- Study completion
- 7 Apr 2020 (actual)
- First posted
- 13 Sep 2019 (actual)
- Results
- Posted 27 Jun 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| APP13007 0.05% twice daily (BID) [Part A] | Experimental | Drug: APP13007, 0.05%1 drop 0.05% APP13007 twice daily for 21 days to the operated eye |
| APP13007 0.05% Placebo twice daily (BID) [Part A] | Experimental | Drug: APP13007 Placebo, 0.05%1 drop matching vehicle placebo for 0.05% APP13007 twice daily for 21 days to the operated eye |
| APP13007 0.05% twice daily (BID) and once daily (QD) [Part B] | Experimental | Drug: APP13007, 0.05%1 drop 0.05% APP13007 twice daily for 3 days followed by 1 drop once daily for 11 days to the operated eye |
| APP13007 0.05% Placebo twice daily (BID) and once daily (QD) [Part B] | Experimental | Drug: APP13007 Placebo, 0.05%1 drop matching vehicle placebo for 0.05% APP13007 twice daily for 3 days followed by 1 drop once daily for 11 days to the operated eye |
| APP13007 0.1% twice daily (BID) and once daily (QD) [Part B] | Experimental | Drug: APP13007, 0.1%1 drop 0.1% APP13007 twice daily for 3 days followed by 1 drop once daily for 11 days to the operated eye |
| APP13007 0.1% Placebo twice daily (BID) and once daily (QD) [Part B] | Experimental | Drug: APP13007 Placebo, 0.1%1 drop matching vehicle placebo for 0.1% APP13007 twice daily for 3 days followed by 1 drop once daily for 11 days to the operated eye |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Expected to undergo unilateral uncomplicated cataract extraction via phacoemulsification and posterior chamber intraocular lens implantation in one eye.
- In Investigator's opinion, have Early Treatment Diabetic Retinopathy Study estimated potential of 0.7 (20/100) or better in study eye.
- Have > 10 and ≤ 30 cells in anterior chamber.
- Have an intraocular pressure ≤ 30 mmHg.
Key exclusion criteria (2 listed)
- Have an anterior chamber cell count > 0 or any evidence of intraocular inflammation.
- Have a score > 0 on Ocular Pain Assessment in either eye.
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% twice daily (BID) [Part A], APP13007 0.05% twice daily (BID) and once daily (QD) [Part B] |
| APP13007, 0.1%APP13007 eye drop, 0.1% | Drug | APP13007 0.1% twice daily (BID) and once daily (QD) [Part B] |
| APP13007 Placebo, 0.05%APP13007 placebo eyedrop, 0.05% | Drug | APP13007 0.05% Placebo twice daily (BID) [Part A], APP13007 0.05% Placebo twice daily (BID) and once daily (QD) [Part B] |
| APP13007 Placebo, 0.1%APP13007 placebo eyedrop, 0.1% | Drug | APP13007 0.1% Placebo twice daily (BID) and once daily (QD) [Part B] |
Primary outcome
Number of Treatment Emergent Adverse Events
Time frame: From First dose to Post-operative Day 28 (Part A) or Day 22 (Part B)
Number of treatment emergent adverse events and number of participants.
Intraocular Pressure - Change From Baseline (POD1 Prior to Dosing) to End-of-Treatment in the Operated Study Eye
Time frame: Baseline and Post-operative Day 22 (Part A) or Day 15 (Part B)
Intraocular pressure is measured in mm Hg at each study visit with a Goldmann applanation tonometer. The change from baseline is calculated by subtracting the pretreatment measurement value from the value at each visit.
Absolute Anterior Chamber Cell Count - Change From Baseline (POD1 Prior to Dosing) to POD 15 in the Operated Study Eye
Time frame: Baseline and Post-operative 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.
Visual Acuity - Change From Baseline (POD1 Prior to Dosing) to End-of Treatment in the Operated Study Eye
Time frame: Baseline and Post-operative Day 22 (Part A) or Day 15 (Part B)
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 number of incorrect letters.
Ocular Pain Grade - Change From Baseline (POD1 Prior to Dosing) to POD15 in the Operated Study Eye
Time frame: Baseline and Post-operative Day 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).
4 secondary outcomes
Subjects With Anterior Chamber Cell Count = 0 at POD15 in the Operated Study Eye Without Rescue Medication
Time frame: Post-operative Day 15
Subjects With Ocular Pain Grade = 0 at POD 15 in the Operated Study Eye Without Rescue Medication
Time frame: Post-operative Day 15
Anterior Chamber Flare - Change From Baseline (POD1 Prior to Dosing) to End-of Treatment in the Operated Study Eye
Time frame: Baseline and Post-operative Day 22 (Part A) or Day 15 (Part B)
Subjects Using of Anti-inflammatory 'Rescue' Medication Through End-of-Treatment
Time frame: First dose to Post-operative Day 22 (Part A) or Day 15 (Part B)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41329923Levenson J, Walters TR, Martel J, Wang L, Nunez DJ. Dose-selection study of clobetasol propionate ophthalmic suspension that evaluated inflammation and pain after cataract surgery. J Cataract Refract Surg. 2026 May 1;52(5):444-451. doi: 10.1097/j.jcrs.0000000000001845.
- 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.
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing APP13007, 0.05% and APP13007, 0.1% in people with Ocular Inflammation and Pain After Cataract Surgery, run by Formosa Pharmaceuticals, Inc. at 9 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 2 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 27 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 27 Jun 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?
Number of Treatment Emergent Adverse Events (time frame: From First dose to Post-operative Day 28 (Part A) or Day 22 (Part B)). The study lists 5 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 NCT04089735, which also lists 1 linked publication.
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 27 Jun 2023.