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

Sponsor

Formosa Pharmaceuticals, Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT04739709

Collaborator

(none)

378

Enrollment

Locations

Arms

14.1

Actual Duration (Months)

10.5

Patients Per Site

0.7

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Ocular Inflammation and Pain	Drug: APP13007, 0.05% Drug: Matching Vehicle Placebo for APP13007, 0.05%	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

378 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Jan 11, 2021

Actual Primary Completion Date :

Mar 17, 2022

Actual Study Completion Date :

Mar 17, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: APP13007 0.05% BID 1 drop APP13007 0.05% twice daily for 14 days to study (operated) eye	Drug: APP13007, 0.05% APP13007 eye drop, 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% Matching vehicle placebo eye drop

Arm

Intervention/Treatment

Experimental: APP13007 0.05% BID

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

Drug: APP13007, 0.05%

APP13007 eye drop, 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%

Matching vehicle placebo eye drop

Outcome Measures

Primary Outcome Measures

Efficacy as Assessed by Anterior Chamber Cell (ACC) Count [Postoperative Day (POD) 8 through POD 15]
Proportion of subjects with ACC count = 0 (0 = 0 ACC, 2 = 1-5 ACC, 3 = 6-15 ACC, 4 = 16-30 ACC, 5 = >30 ACC)
Efficacy as Assessed by Ocular Pain Grade [Postoperative Day (POD) 4 through POD 15]
Proportion of subjects with Ocular Pain Grade = 0 (0 = no pain; 4 = severe pain)
Safety as Assessed by Adverse Events (AEs) [Screening through Postoperative Day 22]
Incidence of ocular and systemic AEs
Safety as Assessed by Best Corrected Visual Acuity (BCVA), Slit-lamp Biomicroscopy, and Dilated Indirect Ophthalmoscopy [Screening through Postoperative Day 22]
Change from baseline in ocular signs to each post-surgery visit
Safety as Assessed by Intraocular Pressure (IOP) [Screening through Postoperative Day 22]
Change from baseline in IOP using the Goldman applanation tonometer to each visit

Secondary Outcome Measures

Efficacy as Assessed by Anterior Chamber Cell (ACC) Count [Through Postoperative Day 15]
Proportion of subjects with ACC count = 0 (0 = 0 ACC, 2 = 1-5 ACC, 3 = 6-15 ACC, 4 = 16-30 ACC, 5 = >30 ACC)
Efficacy as Assessed by Ocular Pain Grade [Through Postoperative Day 15]
Proportion of subjects with Ocular Pain Grade = 0 (0 = no pain; 4 = severe pain)
Efficacy as Assessed by Anterior Chamber Flare (ACF) [Through Postoperative Day 15]
Proportion of subjects with ACF Grade = 0 (0 = none; 4 = intense)
Efficacy as Assessed by Anterior Chamber Flare (ACF) [Postoperative Day (POD) 8 through POD 15]
Proportion of subjects with ACF Grade = 0 (0 = none; 4 = Intense)
Efficacy as Assessed by Anterior Chamber Cell (ACC) Count [Through Postoperative Day 15]
Mean change in baseline in ACC Grade. Measurement of ACC grade using a slit lamp biomicroscope and a 5 point grading scale (0 = 0 ACC, 2 = 1-5 ACC, 3 = 6-15 ACC, 4 = 16-30 ACC, 5 = >30 ACC)
Efficacy as Assessed by Ocular Pain Grade [Through Postoperative Day 15]
Mean change in baseline in Ocular Pain Grade. Measurement of Ocular Pain Grade using a slit lamp biomicroscope and a 5 point grading scale (0 = no pain; 4 = severe pain)
Efficacy as Assessed by Anterior Chamber Flare (ACF) [Through Postoperative Day 15]
Mean change in baseline in ACF Grade. Measurement of ACF using a slit lamp biomicroscope and a 5 point rating scale (0 = none; 4 = intense)
Efficacy as Assessed by Number of Subjects Rescued [Postoperative Day (POD) 1 through POD 22]
Number of subjects rescued on or prior to each visit and overall

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Schwartz Laser Eye Center	Scottsdale	Arizona	United States	85260
2	Global Research Management	Glendale	California	United States	91204
3	Inland Eye Specialists	Hemet	California	United States	92545
4	SoCal Eye Physicians and Associates	Long Beach	California	United States	90805
5	North Valley Eye Medical Group, Inc.	Mission Hills	California	United States	91345
6	LoBue Laser and Eye Medical Center, Inc.	Murrieta	California	United States	92562
7	Pendleton Eye Center	Oceanside	California	United States	92056
8	Martel Eye Medical Group	Rancho Cordova	California	United States	95670
9	Shasta Eye Medical Group, Inc.	Redding	California	United States	96001
10	Icon Eye Care	Grand Junction	Colorado	United States	81501
11	Levenson Eye Associates	Jacksonville	Florida	United States	32204
12	International Eye Associates, PA	Ormond Beach	Florida	United States	32174
13	Newsom Eye and Laser Center	Sebring	Florida	United States	33870
14	Coastal Research Associates, LLC	Roswell	Georgia	United States	30076
15	Jacksonsye, S.C.	Lake Villa	Illinois	United States	60046
16	Midwest Cornea Associates, LLC	Carmel	Indiana	United States	46290
17	Senior Health Services	Louisville	Kentucky	United States	40220
18	Silverstein Eye Centers, PC	Kansas City	Missouri	United States	64133
19	Ophthalmology Consultants, Ltd.	Saint Louis	Missouri	United States	63131
20	Comprehensive Eye Care, Ltd.	Washington	Missouri	United States	63090
21	NV Eye Surgery	Henderson	Nevada	United States	89052
22	Center For Sight	Las Vegas	Nevada	United States	89145
23	Raymond Fong, MD, PC	New York	New York	United States	10013
24	Carolina Eye Associates	Southern Pines	North Carolina	United States	28387
25	Eye Physicians, LLC	Columbus	Ohio	United States	43215
26	The Eye Physicians, LLC	Columbus	Ohio	United States	43215
27	Bucci Laser Vision Institute	Wilkes-Barre	Pennsylvania	United States	18702
28	Keystone Research Ltd.	Austin	Texas	United States	78731
29	Retina Research Center, PLLC	Austin	Texas	United States	78750
30	Houston Eye Associates	Houston	Texas	United States	77008
31	Advanced Laser Vision and Surgical Institute	Houston	Texas	United States	77034
32	Lake Travis Eye and Laser Center	Lakeway	Texas	United States	78738
33	R and R Eye Research, LLC	San Antonio	Texas	United States	78229
34	San Antonio Eye Center	San Antonio	Texas	United States	78238
35	Stacy R. Smith, MD, PC	Salt Lake City	Utah	United States	84117
36	Centro Oftalmologico Metropolitano	San Juan		Puerto Rico	00921

Sponsors and Collaborators

Formosa Pharmaceuticals, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Formosa Pharmaceuticals, Inc.

ClinicalTrials.gov Identifier:

NCT04739709

Other Study ID Numbers:

CPN-301

First Posted:

Feb 5, 2021

Last Update Posted:

Jul 27, 2022

Last Verified:

Jul 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Cataract

Capsule Opacification

Inflammation

Study Results

No Results Posted as of Jul 27, 2022