TC-002-301: Prospective, Double-masked, Randomized, Multi-center, Active-controlled, Parallel-group, 3-month Study Assessing the Safety & Ocular Hypotensive Efficacy of TC-002 Ophthalmic Solution Compared to Latanoprost Ophthalmic Solution 0.005% in Subjects With Elevated Intraocular Pressure

Sponsor

TearClear Corp (Industry)

Overall Status

Active, not recruiting

CT.gov ID

NCT05165290

Collaborator

(none)

300

Enrollment

Locations

Arms

9.1

Anticipated Duration (Months)

Patients Per Site

1.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Prospective, double-masked, randomized, multi-center, active-controlled, parallel-group, 3-month study assessing the safety and ocular hypotensive efficacy of TearClear latanoprost Ophthalmic Solution, 0.005% (TC-002) compared to latanoprost Ophthalmic Solution, 0.005% (LAT) in subjects with elevated intraocular pressure at approximately 20 study sites located in the United States

Condition or Disease	Intervention/Treatment	Phase
Elevated Intraocular Pressure	Drug: Latanoprost ophthalmic solution, 0.005% Drug: TC-002 latanoprost ophthalmic solution, 0.005%	Phase 3

Detailed Description

This is a Phase 3, randomized, investigator-masked, multicenter, parallel-group trial comparing two ophthalmic solution formulations of latanoprost at a fixed dose of 0.005% administered once daily (QD) for 12 weeks.

Approximately 300 subjects will be randomized in this study at approximately 20 sites in the United States (US).

Treatment assignments will be masked to TearClear, study subjects, Investigators and site staff. Because the container closure for the investigational product is different, this study will use an unmasked dosing coordinator at each study site. All clinical trial supplies will be masked by using carton boxes to mask the appearance of the immediate container closure.

At approximately 2 select sites, approximately10% of total randomized subjects will have systemic PK labs drawn.

The study involves 7 clinic visits, including Screening (Visit 1), Randomization (Visit 2) and treatment visits (Visits 3, 5 and 7, during which ophthalmic assessments will occur and IOP will be assessed diurnally. There will be two interim IP dispensation visits (Visits 4 and 6).

Study Design

Study Type:

Interventional

Anticipated Enrollment :

300 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Masking Description:

Treatment assignments will be masked to the Sponsor, subjects, Investigators and select investigative staff, until completion of the study and the final database is locked. The appearance of the bottles in the two treatment arms are not identical; however, the cartons and labeling on the cartons in which the bottles are supplied will be identical and identified with unique kit numbers. Therefore, the dedicated dosing coordinator will handle IP-related responsibilities but will be otherwise uninvolved in study assessments. Appropriate precautions must be taken to prevent unauthorized access to the randomization scheme. Unless the subject's safety requires otherwise and if time permits, the decision to unmask an individual subject's treatment assignment is to be made jointly by the Investigator and Sponsor's medical monitor after consultation with the Sponsor, thus leaving the masking of the remaining subjects intact.

Primary Purpose:

Treatment

Official Title:

Prospective, Double-masked, Randomized, Multi-center, Active-controlled, Parallel-group, 3-month Study Assessing the Safety & Ocular Hypotensive Efficacy of TC-002 Ophthalmic Solution Compared to Latanoprost Ophthalmic Solution 0.005% in Subjects With Elevated Intraocular Pressure

Actual Study Start Date :

Nov 29, 2021

Anticipated Primary Completion Date :

Sep 1, 2022

Anticipated Study Completion Date :

Sep 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: LAT, 0.005% Commercially available FDA-approved generic latanoprost ophthalmic solution, 0.005%	Drug: Latanoprost ophthalmic solution, 0.005% Commercially available, FDA-approved generic latanoprost ophthalmic solution, 0.005% (LAT) without modification will be used as the active control
Experimental: TC-002 TC-002, TearClear latanoprost ophthalmic solution, 0.005%	Drug: TC-002 latanoprost ophthalmic solution, 0.005% TC-002 is formulated using the commercially available latanoprost drug substance; delivered drop to the eye is preservative-free.

Arm

Intervention/Treatment

Active Comparator: LAT, 0.005%

Commercially available FDA-approved generic latanoprost ophthalmic solution, 0.005%

Drug: Latanoprost ophthalmic solution, 0.005%

Commercially available, FDA-approved generic latanoprost ophthalmic solution, 0.005% (LAT) without modification will be used as the active control

Experimental: TC-002

TC-002, TearClear latanoprost ophthalmic solution, 0.005%

Drug: TC-002 latanoprost ophthalmic solution, 0.005%

TC-002 is formulated using the commercially available latanoprost drug substance; delivered drop to the eye is preservative-free.

Outcome Measures

Primary Outcome Measures

Primary efficacy endpoint is the difference in mean change from baseline (CFB) in IOP [Weeks 2, 6, and 12 at 8:00 AM, 10:00 AM, and 4:00 PM.]

Secondary Outcome Measures

Secondary efficacy endpoints include diurnal (average of 8:00 AM, 10:00 AM, and 4:00 PM measurements) IOP [Weeks 2, 6, and 12.]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Greater than 18 years old.
Have been diagnosed and treated for bilateral open-angle glaucoma or ocular hypertension in both eyes.
Currently and for at least 30 days prior to screening, are being treated with a stable dose of latanoprost ophthalmic solution or prostaglandin analog for which there is a documented and positive treatment response with either agent maintained within both eyes.
Have best corrected visual acuity (BCVA) via Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity (VA) score +0.6 logarithm of the minimum angle of resolution (logMAR) or better in each eye.
At Visit 1, have IOP on prostaglandin or prostaglandin analog single therapy ≤ 21mmHg, at Visit 2, have diurnal IOP between 22 and 30 mmHG, inclusive for each eye.
In the Investigator's judgment, are able to safely discontinue current ocular hypotensive medication during the washout period.
Willing and able to avoid wearing contact lenses from Visit 1 (Screening) and for the duration of the trial.
Willing and able to self-administer or have an able person available on a daily basis to assist with administration of study medication.
Female subjects must either be incapable of pregnancy because of bilateral oophorectomy, hysterectomy, or bilateral tubal ligation, or be post-menopausal (have been amenorrheic for at least 2 years) or must use an effective (e.g., double-barrier) method of birth control for the duration of the study. Female subjects of childbearing potential must have a negative pregnancy test and not be nursing.
Willing and able to comply with all study procedures.

Exclusion Criteria:

Causes of glaucoma other than primary open-angle glaucoma, including:
narrow angles (3 quadrants with less than Grade 2 according to Shaffer anterior chamber angle grading system) and subjects with angle closure
clinically significant peripheral anterior synechiae
congenital glaucoma
a history of angle closure in either eye
aphakic glaucoma
traumatic glaucoma
neovascular glaucoma
pigmentary glaucoma
pseudoexfoliative glaucoma
drug-induced glaucoma
Using a multi-drop treatment (other than prostaglandin or prostaglandin analog) for IOP-lowering medications.
Advanced glaucoma or subjects with a cup/disc ratio greater than 0.8.
Have undergone incisional IOP-lowering surgeries a placement or removal of minimally invasive glaucoma implant (MIG) in either eye.
Have undergone non-incisional IOP-lowering surgeries within the past 6 months.
Used anti-vascular endothelial growth factor (anti-VEGF) within 12 months of screening.
Used intraocular, periocular or topical corticosteroids within 60 days of screening.
Have received laser surgery for glaucoma (selective laser trabeculoplasty [SLT] or argon laser trabeculoplasty [ALT]) within 6 months of screening.
Have uveitis, iritis or congenital aphakia.
Are unwilling to discontinue current glaucoma medication within 30 days of the randomization (Visit 2).
Have had intraocular or periocular surgery within the past 3 months.
Are non-responsive to topical prostaglandins, prostamides or prostaglandin analogs in the Investigator's judgement.
History of previous complicated cataract surgery, or previous refractive keratotomy in either eye.
Used miotics and oral/topical carbonic anhydrase inhibitors within 5 days of screening.
Have any known hypersensitivity to any components of the formulation or latanoprost.
Have participated in a clinical trial for IOP-lowering investigational product or exposure to an IP within the prior 30 days.
In the judgement of the Investigator, have previous or currently active clinically significant systemic or ocular disease in either eye that could affect study outcome.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Orange County Ophthalmology Medical Group	Garden Grove	California	United States	92843
2	Global Research Management	Glendale	California	United States	91204
3	North Valley Eye Medical Group	Mission Hills	California	United States	91345
4	Eye Research Foundation	Newport Beach	California	United States	92663
5	North Bay Eye Associates	Petaluma	California	United States	94954
6	Martel Eye Medical Group	Rancho Cordova	California	United States	95670
7	Wolstan & Goldberg Eye Associates	Torrance	California	United States	90505
8	Michael K. Tran, MD	Westminster	California	United States	92683
9	Segal Drug Trials	Delray Beach	Florida	United States	33484
10	Shettle Eye Research Inc.	Largo	Florida	United States	33773
11	International Research Center	Tampa	Florida	United States	33603
12	The Eyecare Institute/Butcherton Clinical Trials	Louisville	Kentucky	United States	40206
13	Rochester Ophthalmological Group PA	Rochester	New York	United States	14618
14	Abrams Eye Center	Cleveland	Ohio	United States	44115
15	Scott & Christie Associates PC	Cranberry Township	Pennsylvania	United States	16066
16	Total Eye Care P.A.	Memphis	Tennessee	United States	38119
17	Louis M. Alpern, M.D., M.P.H., P.A.	El Paso	Texas	United States	79902
18	Houston Eye Associates	Houston	Texas	United States	77008
19	R&R Research LLC	San Antonio	Texas	United States	78229
20	San Antonio Eye Center	San Antonio	Texas	United States	78238