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CompletedNCT04739709Updated Jul 20, 2023Results posted

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

A Phase 3 interventional study of APP13007, 0.05% and Matching Vehicle Placebo for APP13007, 0.05% in Ocular Inflammation and Pain, sponsored by Formosa Pharmaceuticals, Inc.. Completed at 35 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-07-20.

Sponsored by Formosa Pharmaceuticals, Inc. · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
378
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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 eligibility for randomization to study treatment.

02

Conditions studied

  • Ocular Inflammation and Pain

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03

In context

Pain

2,450 studies on the registry are indexed under Pain; 945 are open to participants now.

This study's enrollment of 378 is above the median of 70 across 2,101 interventional studies indexed under Pain.

Browse Pain studies →

Lead sponsor

Formosa Pharmaceuticals, Inc. is the lead sponsor of 3 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
378 participants (actual)

Study arms

  • Experimental
    APP13007 0.05% BID

    1 drop APP13007 0.05% twice daily for 14 days to study (operated) eye

    Drug: APP13007, 0.05%

  • Placebo comparator
    Matching Vehicle Placebo

    1 drop matching vehicle place twice daily for 14 days to study (operated) eye

    Drug: Matching Vehicle Placebo for APP13007, 0.05%

Interventions

  • DrugAPP13007, 0.05%

    APP13007 eye drop, 0.05%

  • DrugMatching Vehicle Placebo for APP13007, 0.05%

    Matching vehicle placebo eye drop

06

What researchers measure

Primary outcomes

  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.

    Time frame: 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).

    Time frame: 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.

    Time frame: From First dose to Postoperative Day 22

Secondary outcomes

  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

    Time frame: 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

    Time frame: 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).

    Time frame: 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).

    Time frame: 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).

    Time frame: 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).

    Time frame: 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).

    Time frame: 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).

    Time frame: 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

    Time frame: 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).

    Time frame: 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).

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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

    Time frame: First dose to Postoperative Day 15

07

Results

Posted Jul 5, 2023

Participant flow

A multi-center US study in which 27 sites recruited subjects between January 2021 and February 2022.

Participant flow — Overall Study
MilestoneAPP13007 0.05% BIDMatching Vehicle Placebo
Started181197
Completed180197
Not completed10
Withdrew: Physician decision10

Outcome measures

PrimaryParticipants 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.

Time frame:
Postoperative Day 8 and Postoperative Day 15
Reported as:
Count of participants · Participants
Participants With ACC Count = 0 at All Visits From Postoperative Day 8 Through Postoperative Day 15 Without Rescue Medication
ParticipantsAPP13007 0.05% BIDMatching Vehicle Placebo
Participants With ACC Count = 0 at All Visits From Postoperative Day 8 Through Postoperative Day 15 Without Rescue Medication4810
Statistical analysis
  • APP13007 0.05% BID vs Matching Vehicle Placebo · Chi-squared · p = <0.001
PrimaryParticipants 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).

Time frame:
Postoperative Day 4, Postoperative Day 8 and Postoperative Day 15
Reported as:
Count of participants · Participants
Participants With Ocular Pain Grade = 0 at All Visits From Postoperative Day 4 Through Postoperative Day 15 Without Rescue Medication
ParticipantsAPP13007 0.05% BIDMatching Vehicle Placebo
Participants With Ocular Pain Grade = 0 at All Visits From Postoperative Day 4 Through Postoperative Day 15 Without Rescue Medication12346
Statistical analysis
  • APP13007 0.05% BID vs Matching Vehicle Placebo · Chi-squared · p = <0.001
PrimaryParticipants With Treatment-emergent Adverse Events (AEs)

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

Time frame:
From First dose to Postoperative Day 22
Reported as:
Count of participants · Participants
Participants With Treatment-emergent Adverse Events (AEs)
ParticipantsAPP13007 0.05% BIDMatching Vehicle Placebo
Participants With Treatment-emergent Adverse Events (AEs)3839
SecondaryParticipants 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

Time frame:
Postoperative Day 8
Reported as:
Count of participants · Participants
Participants With Anterior Chamber Cell Grade = 0 at POD8 Without Rescue Medication
ParticipantsAPP13007 0.05% BIDMatching Vehicle Placebo
Participants With Anterior Chamber Cell Grade = 0 at POD8 Without Rescue Medication5923
Statistical analysis
  • APP13007 0.05% BID vs Matching Vehicle Placebo · Chi-squared · p = <0.001
SecondaryParticipants 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

Time frame:
Postoperative Day 15
Reported as:
Count of participants · Participants
Participants With Anterior Chamber Cell Grade = 0 at POD15 Without Rescue Medication
ParticipantsAPP13007 0.05% BIDMatching Vehicle Placebo
Participants With Anterior Chamber Cell Grade = 0 at POD15 Without Rescue Medication10631
Statistical analysis
  • APP13007 0.05% BID vs Matching Vehicle Placebo · Chi-squared · p = <0.001
SecondaryParticipants 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).

Time frame:
Postoperative Day 4
Reported as:
Count of participants · Participants
Participants With Ocular Pain Grade = 0 at POD4 Without Rescue Medication
ParticipantsAPP13007 0.05% BIDMatching Vehicle Placebo
Participants With Ocular Pain Grade = 0 at POD4 Without Rescue Medication14086
Statistical analysis
  • APP13007 0.05% BID vs Matching Vehicle Placebo · Chi-squared · p = <0.001
SecondaryParticipants 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).

Time frame:
Postoperative Day 8
Reported as:
Count of participants · Participants
Participants With Ocular Pain Grade = 0 at POD8 Without Rescue Medication
ParticipantsAPP13007 0.05% BIDMatching Vehicle Placebo
Participants With Ocular Pain Grade = 0 at POD8 Without Rescue Medication14984
Statistical analysis
  • APP13007 0.05% BID vs Matching Vehicle Placebo · Chi-squared · p = <0.001
SecondaryParticipants 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).

Time frame:
Postoperative Day 15
Reported as:
Count of participants · Participants
Participants With Ocular Pain Grade = 0 at POD15 Without Rescue Medication
ParticipantsAPP13007 0.05% BIDMatching Vehicle Placebo
Participants With Ocular Pain Grade = 0 at POD15 Without Rescue Medication16483
Statistical analysis
  • APP13007 0.05% BID vs Matching Vehicle Placebo · Chi-squared · p = <0.001
SecondaryParticipants 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).

Time frame:
Postoperative Day 4
Reported as:
Count of participants · Participants
Participants With Anterior Chamber Flare (ACF) = 0 at POD4 Without Rescue Medication
ParticipantsAPP13007 0.05% BIDMatching Vehicle Placebo
Participants With Anterior Chamber Flare (ACF) = 0 at POD4 Without Rescue Medication11179
Statistical analysis
  • APP13007 0.05% BID vs Matching Vehicle Placebo · Chi-squared · p = <0.001
SecondaryParticipants 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).

Time frame:
Postoperative Day 8
Reported as:
Count of participants · Participants
Participants With Anterior Chamber Flare (ACF) = 0 at POD8 Without Rescue Medication
ParticipantsAPP13007 0.05% BIDMatching Vehicle Placebo
Participants With Anterior Chamber Flare (ACF) = 0 at POD8 Without Rescue Medication14275
Statistical analysis
  • APP13007 0.05% BID vs Matching Vehicle Placebo · Chi-squared · p = <0.001
SecondaryParticipants 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).

Time frame:
Postoperative Day 15
Reported as:
Count of participants · Participants
Participants With Anterior Chamber Flare (ACF) = 0 at POD15 Without Rescue Medication
ParticipantsAPP13007 0.05% BIDMatching Vehicle Placebo
Participants With Anterior Chamber Flare (ACF) = 0 at POD15 Without Rescue Medication15965
Statistical analysis
  • APP13007 0.05% BID vs Matching Vehicle Placebo · Chi-squared · p = <0.001
SecondaryAnterior 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

Time frame:
Baseline and Postoperative Day 15
Reported as:
Least squares mean · grade on a scale
Anterior Chamber Cell Grade - Change From Baseline (POD1 Prior to Dosing) to POD 15
grade on a scaleAPP13007 0.05% BIDMatching Vehicle Placebo
Anterior Chamber Cell Grade - Change From Baseline (POD1 Prior to Dosing) to POD 15-2.1 ± 0.1-0.6 ± 0.1
Statistical analysis
  • APP13007 0.05% BID vs Matching Vehicle Placebo · ANCOVA · p = <0.001 · Mean difference (net): -1.6 · 95% CI -1.8 to -1.3Treatment Difference = APP13007-Placebo. Mean Difference Is the least-squares mean difference from the ANCOVA model with treatment as a fixed effect and baseline as a covariate.
SecondaryOcular 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).

Time frame:
Baseline and Postoperative Day 15
Reported as:
Least squares mean · grade on a scale
Ocular Pain Grade - Change From Baseline (POD1 Prior to Dosing) to POD 15
grade on a scaleAPP13007 0.05% BIDMatching Vehicle Placebo
Ocular Pain Grade - Change From Baseline (POD1 Prior to Dosing) to POD 15-1.1 ± 0.1-0.3 ± 0.1
Statistical analysis
  • APP13007 0.05% BID vs Matching Vehicle Placebo · ANCOVA · p = <0.001 · Mean difference (net): -0.7 · 95% CI -0.9 to -0.6Treatment Difference = APP13007-Placebo. Mean Difference Is the least-squares mean difference from the ANCOVA model with treatment as a fixed effect and baseline as a covariate.
SecondaryAnterior 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).

Time frame:
Baseline and Postoperative Day 15
Reported as:
Least squares mean · grade on a scale
Anterior Chamber Flare (ACF) - Change From Baseline (POD1 Prior to Dosing) to POD 15
grade on a scaleAPP13007 0.05% BIDMatching Vehicle Placebo
Anterior Chamber Flare (ACF) - Change From Baseline (POD1 Prior to Dosing) to POD 15-0.7 ± 0.1-0.0 ± 0.0
Statistical analysis
  • APP13007 0.05% BID vs Matching Vehicle Placebo · ANCOVA · p = <0.001 · Mean difference (net): -0.7 · 95% CI -0.8 to -0.5Treatment Difference = APP13007-Placebo. Mean Difference Is the least-squares mean difference from the ANCOVA model with treatment as a fixed effect and baseline as a covariate.
SecondaryBest 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.

Time frame:
Baseline and Postoperative Day 4
Reported as:
Least squares mean · logMAR score
Best Corrected Visual Acuity - Change From Baseline (POD1 Prior to Dosing) to POD4
logMAR scoreAPP13007 0.05% BIDMatching Vehicle Placebo
Best Corrected Visual Acuity - Change From Baseline (POD1 Prior to Dosing) to POD4-0.07 ± 0.01-0.04 ± 0.01
Statistical analysis
  • APP13007 0.05% BID vs Matching Vehicle Placebo · ANCOVA · p = 0.017 · Mean difference (net): -0.03 · 95% CI -0.06 to -0.01Treatment Difference = APP13007-Placebo. Mean Difference Is the least-squares mean difference from the ANCOVA model with treatment as a fixed effect and baseline as a covariate.
SecondaryBest 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.

Time frame:
Baseline and Postoperative Day 8
Reported as:
Least squares mean · logMAR score
Best Corrected Visual Acuity - Change From Baseline (POD1 Prior to Dosing) to POD8
logMAR scoreAPP13007 0.05% BIDMatching Vehicle Placebo
Best Corrected Visual Acuity - Change From Baseline (POD1 Prior to Dosing) to POD8-0.10 ± 0.01-0.02 ± 0.01
Statistical analysis
  • APP13007 0.05% BID vs Matching Vehicle Placebo · ANCOVA · p = <0.001 · Mean difference (net): -0.07 · 95% CI -0.10 to -0.04Treatment Difference = APP13007-Placebo. Mean Difference Is the least-squares mean difference from the ANCOVA model with treatment as a fixed effect and baseline as a covariate.
SecondaryBest 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.

Time frame:
Baseline and Postoperative Day 15
Reported as:
Least squares mean · logMAR score
Best Corrected Visual Acuity - Change From Baseline (POD1 Prior to Dosing) to POD15
logMAR scoreAPP13007 0.05% BIDMatching Vehicle Placebo
Best Corrected Visual Acuity - Change From Baseline (POD1 Prior to Dosing) to POD15-0.11 ± 0.01-0.02 ± 0.01
Statistical analysis
  • APP13007 0.05% BID vs Matching Vehicle Placebo · ANCOVA · p = <0.001 · Mean difference (net): -0.09 · 95% CI -0.11 to -0.06Treatment Difference = APP13007-Placebo. Mean Difference Is the least-squares mean difference from the ANCOVA model with treatment as a fixed effect and baseline as a covariate.
SecondaryParticipants 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

Time frame:
First dose to Postoperative Day 15
Reported as:
Count of participants · Participants
Participants Using of Anti-inflammatory 'Rescue' Medication Through End-of-Treatment
ParticipantsAPP13007 0.05% BIDMatching Vehicle Placebo
Participants Using of Anti-inflammatory 'Rescue' Medication Through End-of-Treatment10100
Statistical analysis
  • APP13007 0.05% BID vs Matching Vehicle Placebo · Chi-squared · p = <0.001

Adverse events

Collected over All-Cause Mortality data were collected from informed consent through Postoperative Day 22. Serious adverse events were collected from informed consent through Postoperative Day 22. Other (not Including Serious) adverse events were collected from the first dose through Postoperative Day 22.. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
APP13007 0.05% BID0/181 (0%)0/181 (0%)3/181 (1.7%)
Matching Vehicle Placebo0/197 (0%)0/197 (0%)10/197 (5.1%)
Most frequent other events
Most frequent other events
EventAPP13007 0.05% BIDMatching Vehicle Placebo
Corneal oedemaEye disorders3/18110/197

Baseline characteristics

Intent-to-Treat Population

Age, Continuous
Age, Continuous(Years)APP13007 0.05% BIDMatching Vehicle PlaceboTotal
Mean68.7 ± 8.967.8 ± 8.668.3 ± 8.7
Sex: Female, Male
Sex: Female, Male(Participants)APP13007 0.05% BIDMatching Vehicle PlaceboTotal
Female106119225
Male7578153
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)APP13007 0.05% BIDMatching Vehicle PlaceboTotal
Hispanic or Latino355287
Not Hispanic or Latino146145291
Unknown or Not Reported000
Race (NIH/OMB)
Race (NIH/OMB)(Participants)APP13007 0.05% BIDMatching Vehicle PlaceboTotal
American Indian or Alaska Native112
Asian111627
Native Hawaiian or Other Pacific Islander000
Black or African American182745
White150151301
More than one race123
Unknown or Not Reported000
Region of Enrollment
Region of Enrollment(participants)APP13007 0.05% BIDMatching Vehicle PlaceboTotal
United States181197378
08

Study locations

35 sites
  • Schwartz Laser Eye Center
    Scottsdale, Arizona 85260, United States
  • Global Research Management
    Glendale, California 91204, United States
  • Inland Eye Specialists
    Hemet, California 92545, United States
  • SoCal Eye Physicians and Associates
    Long Beach, California 90805, United States
  • North Valley Eye Medical Group, Inc.
    Mission Hills, California 91345, United States
  • LoBue Laser and Eye Medical Center, Inc.
    Murrieta, California 92562, United States
  • Pendleton Eye Center
    Oceanside, California 92056, United States
  • Martel Eye Medical Group
    Rancho Cordova, California 95670, United States
  • Shasta Eye Medical Group, Inc.
    Redding, California 96001, United States
  • Icon Eye Care
    Grand Junction, Colorado 81501, United States
  • Levenson Eye Associates
    Jacksonville, Florida 32204, United States
  • International Eye Associates, PA
    Ormond Beach, Florida 32174, United States
  • Newsom Eye and Laser Center
    Sebring, Florida 33870, United States
  • Coastal Research Associates, LLC
    Roswell, Georgia 30076, United States
  • Jacksoneye SC
    Columbus, Illinois 60046, United States
  • Midwest Cornea Associates, LLC
    Carmel, Indiana 46290, United States
  • Senior Health Services
    Louisville, Kentucky 40220, United States
  • Silverstein Eye Centers, PC
    Kansas City, Missouri 64133, United States
  • Ophthalmology Consultants, Ltd.
    St Louis, Missouri 63131, United States
  • Comprehensive Eye Care, Ltd.
    Washington, Missouri 63090, United States
  • NV Eye Surgery
    Henderson, Nevada 89052, United States
  • Center For Sight
    Las Vegas, Nevada 89145, United States
  • Raymond Fong, MD, PC
    New York, New York 10013, United States
  • Carolina Eye Associates
    Southern Pines, North Carolina 28387, United States
  • Eye Physicians, LLC
    Columbus, Ohio 43215, United States
  • Bucci Laser Vision Institute
    Wilkes-Barre, Pennsylvania 18702, United States
  • Keystone Research Ltd.
    Austin, Texas 78731, United States
  • Retina Research Center, PLLC
    Austin, Texas 78750, United States
  • Houston Eye Associates
    Houston, Texas 77008, United States
  • Advanced Laser Vision and Surgical Institute
    Houston, Texas 77034, United States
  • Lake Travis Eye and Laser Center
    Lakeway, Texas 78738, United States
  • R and R Eye Research, LLC
    San Antonio, Texas 78229, United States
  • San Antonio Eye Center
    San Antonio, Texas 78238, United States
  • Stacy R. Smith, MD, PC
    Salt Lake City, Utah 84117, United States
  • Centro Oftalmologico Metropolitano
    San Juan, 00921, Puerto Rico
09

References and documents

Study documents

  • Study protocol · May 18, 2021
  • Statistical analysis plan · Feb 24, 2022

Documents are hosted by the registry — open the source record to download them.

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 20, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT04739709
Lead sponsor
Formosa Pharmaceuticals, Inc.
Responsible party
Sponsor
First posted
Feb 5, 2021
Start date
Jan 11, 2021
Primary completion
Mar 17, 2022
Completion
Mar 17, 2022
Results posted
Jul 5, 2023
Last update
Jul 20, 2023

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jul 2023. You cannot join it, but the record below documents what was studied.

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Discussion

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