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

NCT05165290 | Unknown Phase 3 FDA Drug

• 1 other identifier: TC-002-301
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 20

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

Conditions

Elevated Intraocular Pressure

Keywords

elevated IOP; open-angle glaucoma; ocular hypertension

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Secondary efficacy endpoints include diurnal (average of 8:00 AM, 10:00 AM, and 4:00 PM measurements) IOP

  Weeks 2, 6, and 12.

Study Arms (2)

LAT, 0.005%

ACTIVE COMPARATOR

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

Drug: Latanoprost ophthalmic solution, 0.005%

TC-002

EXPERIMENTAL

TC-002, TearClear latanoprost ophthalmic solution, 0.005%

Drug: TC-002 latanoprost ophthalmic solution, 0.005%

Interventions

Latanoprost ophthalmic solution, 0.005% DRUG

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

LAT, 0.005%

TC-002 latanoprost ophthalmic solution, 0.005% DRUG

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

TC-002

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• TearClear Corp: lead

Study Sites (20)

Orange County Ophthalmology Medical Group

Garden Grove, California, 92843, United States

Location

Global Research Management

Glendale, California, 91204, United States

Location

North Valley Eye Medical Group

Mission Hills, California, 91345, United States

Location

Eye Research Foundation

Newport Beach, California, 92663, United States

Location

North Bay Eye Associates

Petaluma, California, 94954, United States

Location

Martel Eye Medical Group

Rancho Cordova, California, 95670, United States

Location

Wolstan & Goldberg Eye Associates

Torrance, California, 90505, United States

Location

Michael K. Tran, MD

Westminster, California, 92683, United States

Location

Segal Drug Trials

Delray Beach, Florida, 33484, United States

Location

Shettle Eye Research Inc.

Largo, Florida, 33773, United States

Location

International Research Center

Tampa, Florida, 33603, United States

Location

The Eyecare Institute/Butcherton Clinical Trials

Louisville, Kentucky, 40206, United States

Location

Rochester Ophthalmological Group PA

Rochester, New York, 14618, United States

Location

Abrams Eye Center

Cleveland, Ohio, 44115, United States

Location

Scott & Christie Associates PC

Cranberry Township, Pennsylvania, 16066, United States

Location

Total Eye Care P.A.

Memphis, Tennessee, 38119, United States

Location

Louis M. Alpern, M.D., M.P.H., P.A.

El Paso, Texas, 79902, United States

Location

Houston Eye Associates

Houston, Texas, 77008, United States

Location

R&R Research LLC

San Antonio, Texas, 78229, United States

Location

San Antonio Eye Center

San Antonio, Texas, 78238, United States

Location

MeSH Terms

Conditions

Ocular Hypertension; Glaucoma, Open-Angle

Condition Hierarchy (Ancestors)

Eye Diseases; Glaucoma

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 17, 2021
• First Posted: December 21, 2021
• Study Start: November 29, 2021
• Primary Completion: September 1, 2022
• Study Completion: September 1, 2022
• Last Updated: May 25, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (20)