Efficacy and Safety of APP13007 for Treatment of Inflammation and Pain After Cataract Surgery Including a Corneal Endothelial Cell Sub-study

• Sponsor: Formosa Pharmaceuticals, Inc. (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT04810962
• Collaborator: (none)
• Enrollment: 370
• Locations: 32
• Arms: 2
• Anticipated Duration (Months): 15.5
• Patients Per Site: 11.6
• Patients Per Site Per Month: 0.7

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; POD1) after uncomplicated surgery for eligibility for randomization to study treatment. The study comprises the Main Study and the Endothelial Cell Sub-study.

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

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 370 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, Including a Corneal Endothelial Cell Sub-study
• Actual Study Start Date: Mar 16, 2021
• Anticipated Primary Completion Date: Jun 30, 2022
• Anticipated Study Completion Date: Jun 30, 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 placebo 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

1. Efficacy as Assessed by Anterior Chamber Cell (ACC) Count [Postoperative Day 8 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)

2. Efficacy as Assessed by Ocular Pain Grade [Postoperative Day 4 through Postoperative Day 15]

   Proportion of subjects with Ocular Pain Grade = 0 (0 = no pain; 4 = severe pain)

3. Safety as Assessed by Adverse Events (AEs) [Screening through Postoperative Day 22]

   Incidence of ocular and systemic AEs

4. Safety as Assessed by Best Corrected Visual Acuity (BCVA) [Screening through Postoperative Day 22]

   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.

5. Safety as Assessed by Ocular Anatomy [Screening through Postoperative Day 22]

   Ocular anatomy is routinely assessed using slit-lamp biomicroscopy and dilated indirect ophthalmoscopy. Ocular tissues are examined at each study visit and any anatomical abnormalities are recorded using standard medical descriptive terminology.

6. Safety as Assessed by Corneal Endothelial Cell Measurements [Screening through Postoperative Day 85]

   Mean changes in corneal endothelial cell density (units: cells/mm2), percent hexagonality (units: % of cells with hexagonal shape) and coefficient of variation in the sizes of the endothelial cells (units: % variation in size between endothelial cells) will be measured from the images obtained using a specular microscope.

7. 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

1. Efficacy as Assessed by Anterior Chamber Cell (ACC) Count [Through Postoperative Day15]

   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)

2. 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)

3. Efficacy as Assessed by Anterior Chamber Flare (ACF) [Through Postoperative Day 15]

   Proportion of subjects with ACF Grade = 0 (0 = none; 4 = intense)

4. Efficacy as Assessed by Anterior Chamber Flare (ACF) [Postoperative Day 8 through Postoperative Day 15]

   Proportion of subjects with ACF Grade = 0 (0 = none; 4 = intense)

5. Efficacy as Assessed by Anterior Chamber Cell Count (ACC) [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)

6. 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)

7. 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)

8. Efficacy as Assessed by Number of Subjects Rescued [Postoperative Day 1 through Postoperative Day 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: No

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	Carrot Eye Center	Mesa	Arizona	United States	85202
2	Cornea and Cataract Consultants of Arizona	Phoenix	Arizona	United States	85032
3	Orange County Ophthalmology Medical Group	Garden Grove	California	United States	92843
4	Premiere Practice Management, LLC	Los Angeles	California	United States	90013
5	LoBue Laser and Eye Medical Center Inc	Murrieta	California	United States	92562
6	Visionary Research Institute	Newport Beach	California	United States	92663
7	North Bay Eye Associates	Petaluma	California	United States	94954
8	Sierra Clinical Trials Research Organization	Santa Ana	California	United States	92705
9	Wolstan and Goldberg Eye Associates	Torrance	California	United States	90505
10	Michael K. Tran, MD, Inc.	Westminster	California	United States	92683
11	Rand Eye Institute	Deerfield Beach	Florida	United States	33064
12	Eye Associates for Fort Myers	Fort Myers	Florida	United States	33901
13	Levenson Eye Associates	Jacksonville	Florida	United States	32204
14	International Research Center	Tampa	Florida	United States	33603
15	Dixon Eye Care	Albany	Georgia	United States	31701
16	Clayton Eye Clinical Research LLC	Morrow	Georgia	United States	30260
17	Chicago Cornea Consultants	Hoffman Estates	Illinois	United States	60169
18	Stiles Eyecare Excellence and Glaucoma Institute, PA	Overland Park	Kansas	United States	66213
19	The Eye Care Center	Louisville	Kentucky	United States	40206
20	Fraser Eye Center	Fraser	Michigan	United States	48026
21	Tauber Eye Center	Kansas City	Missouri	United States	64111
22	Ophthalmology Associates	Saint Louis	Missouri	United States	63131
23	Wellish Vision Institute	Las Vegas	Nevada	United States	89119
24	Metropolitan Eye Research and Surgery Institute	Palisades Park	New Jersey	United States	07650
25	Alterman, Modi and Wolter	Poughkeepsie	New York	United States	12603
26	Cincinnati Eye Institute	Cincinnati	Ohio	United States	45242
27	Eye Care Specialists	Kingston	Pennsylvania	United States	18704
28	Carolina Cataract and Laser Center	Ladson	South Carolina	United States	29456
29	Black Hills Regional Eye Institute	Rapid City	South Dakota	United States	57701
30	Houston Eye Associates	Houston	Texas	United States	77025
31	DCT-Shah Research Institute LLC dba Discovery Clinical Trials	Mission	Texas	United States	78572
32	Round Rock Eye Consultants	Round Rock	Texas	United States	78681

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: NCT04810962
• Other Study ID Numbers: CPN-302
• First Posted: Mar 23, 2021
• Last Update Posted: Mar 16, 2022
• Last Verified: Mar 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Cataract; Capsule Opacification; Inflammation

Study Results

No Results Posted as of Mar 16, 2022