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

Primary Purpose

Ocular Inflammation and Pain

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
APP13007, 0.05%
Matching Vehicle Placebo for APP13007, 0.05%
Sponsored by
Formosa Pharmaceuticals, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ocular Inflammation and Pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients 18 years of age or older expected to undergo unilateral uncomplicated cataract extraction via phacoemulsification and posterior chamber intraocular lens implantation in one eye.
  • Have a pin-hole corrected visual acuity without other correction of ≤ 1.3 logarithm of the minimum angle of resolution (logMAR) in the study eye to be operated and contralateral eye as measured using an Early Treatment Diabetic Retinopathy Study (ETDRS) chart at Visit 1.
  • Willing and able to comply with study requirements and visit schedule.
  • Provide signed and dated informed consent.

Exclusion Criteria:

  • Have a known sensitivity or allergy to clobetasol propionate, corticosteroids, or any of the study medication's components including benzalkonium chloride and soybean lecithin or any routine medication required during cataract surgery or for the conduct of study procedures
  • Have an ACC count > 0 or any evidence of intraocular inflammation (e.g., flare) in either eye at the Screening visit
  • Have a Grade > 0 on the Ocular Pain Assessment in either eye at the Screening visit

Note: Other inclusion/exclusion criteria apply.

Sites / Locations

  • Schwartz Laser Eye Center
  • Global Research Management
  • Inland Eye Specialists
  • SoCal Eye Physicians and Associates
  • North Valley Eye Medical Group, Inc.
  • LoBue Laser and Eye Medical Center, Inc.
  • Pendleton Eye Center
  • Martel Eye Medical Group
  • Shasta Eye Medical Group, Inc.
  • Icon Eye Care
  • Levenson Eye Associates
  • International Eye Associates, PA
  • Newsom Eye and Laser Center
  • Coastal Research Associates, LLC
  • Jacksoneye SC
  • Midwest Cornea Associates, LLC
  • Senior Health Services
  • Silverstein Eye Centers, PC
  • Ophthalmology Consultants, Ltd.
  • Comprehensive Eye Care, Ltd.
  • NV Eye Surgery
  • Center For Sight
  • Raymond Fong, MD, PC
  • Carolina Eye Associates
  • Eye Physicians, LLC
  • Bucci Laser Vision Institute
  • Keystone Research Ltd.
  • Retina Research Center, PLLC
  • Houston Eye Associates
  • Advanced Laser Vision and Surgical Institute
  • Lake Travis Eye and Laser Center
  • R and R Eye Research, LLC
  • San Antonio Eye Center
  • Stacy R. Smith, MD, PC
  • Centro Oftalmologico Metropolitano

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

APP13007 0.05% BID

Matching Vehicle Placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.
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).
Participants With Treatment-emergent Adverse Events (AEs)
Number of participants with ocular and systemic treatment-emergent AEs.

Secondary Outcome Measures

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
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
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).
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).
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).
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).
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).
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).
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
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).
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).
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.
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.
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.
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

Full Information

First Posted
January 26, 2021
Last Updated
July 13, 2023
Sponsor
Formosa Pharmaceuticals, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04739709
Brief Title
Efficacy and Safety of APP13007 for Treatment of Inflammation and Pain After Cataract Surgery
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
January 11, 2021 (Actual)
Primary Completion Date
March 17, 2022 (Actual)
Study Completion Date
March 17, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Formosa Pharmaceuticals, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ocular Inflammation and Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
378 (Actual)

8. Arms, Groups, and Interventions

Arm Title
APP13007 0.05% BID
Arm Type
Experimental
Arm Description
1 drop APP13007 0.05% twice daily for 14 days to study (operated) eye
Arm Title
Matching Vehicle Placebo
Arm Type
Placebo Comparator
Arm Description
1 drop matching vehicle place twice daily for 14 days to study (operated) eye
Intervention Type
Drug
Intervention Name(s)
APP13007, 0.05%
Intervention Description
APP13007 eye drop, 0.05%
Intervention Type
Drug
Intervention Name(s)
Matching Vehicle Placebo for APP13007, 0.05%
Intervention Description
Matching vehicle placebo eye drop
Primary Outcome Measure Information:
Title
Participants With ACC Count = 0 at All Visits From Postoperative Day 8 Through Postoperative Day 15 Without Rescue Medication
Description
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
Title
Participants With Ocular Pain Grade = 0 at All Visits From Postoperative Day 4 Through Postoperative Day 15 Without Rescue Medication
Description
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
Title
Participants With Treatment-emergent Adverse Events (AEs)
Description
Number of participants with ocular and systemic treatment-emergent AEs.
Time Frame
From First dose to Postoperative Day 22
Secondary Outcome Measure Information:
Title
Participants With Anterior Chamber Cell Grade = 0 at POD8 Without Rescue Medication
Description
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
Title
Participants With Anterior Chamber Cell Grade = 0 at POD15 Without Rescue Medication
Description
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
Title
Participants With Ocular Pain Grade = 0 at POD4 Without Rescue Medication
Description
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
Title
Participants With Ocular Pain Grade = 0 at POD8 Without Rescue Medication
Description
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
Title
Participants With Ocular Pain Grade = 0 at POD15 Without Rescue Medication
Description
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
Title
Participants With Anterior Chamber Flare (ACF) = 0 at POD4 Without Rescue Medication
Description
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
Title
Participants With Anterior Chamber Flare (ACF) = 0 at POD8 Without Rescue Medication
Description
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
Title
Participants With Anterior Chamber Flare (ACF) = 0 at POD15 Without Rescue Medication
Description
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
Title
Anterior Chamber Cell Grade - Change From Baseline (POD1 Prior to Dosing) to POD 15
Description
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
Title
Ocular Pain Grade - Change From Baseline (POD1 Prior to Dosing) to POD 15
Description
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
Title
Anterior Chamber Flare (ACF) - Change From Baseline (POD1 Prior to Dosing) to POD 15
Description
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
Title
Best Corrected Visual Acuity - Change From Baseline (POD1 Prior to Dosing) to POD4
Description
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
Title
Best Corrected Visual Acuity - Change From Baseline (POD1 Prior to Dosing) to POD8
Description
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
Title
Best Corrected Visual Acuity - Change From Baseline (POD1 Prior to Dosing) to POD15
Description
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
Title
Participants Using of Anti-inflammatory 'Rescue' Medication Through End-of-Treatment
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients 18 years of age or older expected to undergo unilateral uncomplicated cataract extraction via phacoemulsification and posterior chamber intraocular lens implantation in one eye. Have a pin-hole corrected visual acuity without other correction of ≤ 1.3 logarithm of the minimum angle of resolution (logMAR) in the study eye to be operated and contralateral eye as measured using an Early Treatment Diabetic Retinopathy Study (ETDRS) chart at Visit 1. Willing and able to comply with study requirements and visit schedule. Provide signed and dated informed consent. Exclusion Criteria: Have a known sensitivity or allergy to clobetasol propionate, corticosteroids, or any of the study medication's components including benzalkonium chloride and soybean lecithin or any routine medication required during cataract surgery or for the conduct of study procedures Have an ACC count > 0 or any evidence of intraocular inflammation (e.g., flare) in either eye at the Screening visit Have a Grade > 0 on the Ocular Pain Assessment in either eye at the Screening visit Note: Other inclusion/exclusion criteria apply.
Facility Information:
Facility Name
Schwartz Laser Eye Center
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85260
Country
United States
Facility Name
Global Research Management
City
Glendale
State/Province
California
ZIP/Postal Code
91204
Country
United States
Facility Name
Inland Eye Specialists
City
Hemet
State/Province
California
ZIP/Postal Code
92545
Country
United States
Facility Name
SoCal Eye Physicians and Associates
City
Long Beach
State/Province
California
ZIP/Postal Code
90805
Country
United States
Facility Name
North Valley Eye Medical Group, Inc.
City
Mission Hills
State/Province
California
ZIP/Postal Code
91345
Country
United States
Facility Name
LoBue Laser and Eye Medical Center, Inc.
City
Murrieta
State/Province
California
ZIP/Postal Code
92562
Country
United States
Facility Name
Pendleton Eye Center
City
Oceanside
State/Province
California
ZIP/Postal Code
92056
Country
United States
Facility Name
Martel Eye Medical Group
City
Rancho Cordova
State/Province
California
ZIP/Postal Code
95670
Country
United States
Facility Name
Shasta Eye Medical Group, Inc.
City
Redding
State/Province
California
ZIP/Postal Code
96001
Country
United States
Facility Name
Icon Eye Care
City
Grand Junction
State/Province
Colorado
ZIP/Postal Code
81501
Country
United States
Facility Name
Levenson Eye Associates
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32204
Country
United States
Facility Name
International Eye Associates, PA
City
Ormond Beach
State/Province
Florida
ZIP/Postal Code
32174
Country
United States
Facility Name
Newsom Eye and Laser Center
City
Sebring
State/Province
Florida
ZIP/Postal Code
33870
Country
United States
Facility Name
Coastal Research Associates, LLC
City
Roswell
State/Province
Georgia
ZIP/Postal Code
30076
Country
United States
Facility Name
Jacksoneye SC
City
Columbus
State/Province
Illinois
ZIP/Postal Code
60046
Country
United States
Facility Name
Midwest Cornea Associates, LLC
City
Carmel
State/Province
Indiana
ZIP/Postal Code
46290
Country
United States
Facility Name
Senior Health Services
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40220
Country
United States
Facility Name
Silverstein Eye Centers, PC
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64133
Country
United States
Facility Name
Ophthalmology Consultants, Ltd.
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63131
Country
United States
Facility Name
Comprehensive Eye Care, Ltd.
City
Washington
State/Province
Missouri
ZIP/Postal Code
63090
Country
United States
Facility Name
NV Eye Surgery
City
Henderson
State/Province
Nevada
ZIP/Postal Code
89052
Country
United States
Facility Name
Center For Sight
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89145
Country
United States
Facility Name
Raymond Fong, MD, PC
City
New York
State/Province
New York
ZIP/Postal Code
10013
Country
United States
Facility Name
Carolina Eye Associates
City
Southern Pines
State/Province
North Carolina
ZIP/Postal Code
28387
Country
United States
Facility Name
Eye Physicians, LLC
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43215
Country
United States
Facility Name
Bucci Laser Vision Institute
City
Wilkes-Barre
State/Province
Pennsylvania
ZIP/Postal Code
18702
Country
United States
Facility Name
Keystone Research Ltd.
City
Austin
State/Province
Texas
ZIP/Postal Code
78731
Country
United States
Facility Name
Retina Research Center, PLLC
City
Austin
State/Province
Texas
ZIP/Postal Code
78750
Country
United States
Facility Name
Houston Eye Associates
City
Houston
State/Province
Texas
ZIP/Postal Code
77008
Country
United States
Facility Name
Advanced Laser Vision and Surgical Institute
City
Houston
State/Province
Texas
ZIP/Postal Code
77034
Country
United States
Facility Name
Lake Travis Eye and Laser Center
City
Lakeway
State/Province
Texas
ZIP/Postal Code
78738
Country
United States
Facility Name
R and R Eye Research, LLC
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
San Antonio Eye Center
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78238
Country
United States
Facility Name
Stacy R. Smith, MD, PC
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84117
Country
United States
Facility Name
Centro Oftalmologico Metropolitano
City
San Juan
ZIP/Postal Code
00921
Country
Puerto Rico

12. IPD Sharing Statement

Learn more about this trial

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

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