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

Status unconfirmed · Phase 3

Conditions studied: Elevated Intraocular Pressure

In brief

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

Key facts

Study ID

NCT05165290

Run by

TearClear Corp

People needed

300

Starts

2021-11-29

Expected to finish

2022-09-01

Last updated by the study team

2022-05-25

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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.
• 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.

Where it is running

• Orange County Ophthalmology Medical Group — Garden Grove, California, United States
• Global Research Management — Glendale, California, United States
• North Valley Eye Medical Group — Mission Hills, California, United States
• Eye Research Foundation — Newport Beach, California, United States
• North Bay Eye Associates — Petaluma, California, United States
• Martel Eye Medical Group — Rancho Cordova, California, United States
• Wolstan & Goldberg Eye Associates — Torrance, California, United States
• Michael K. Tran, MD — Westminster, California, United States
• Segal Drug Trials — Delray Beach, Florida, United States
• Shettle Eye Research Inc. — Largo, Florida, United States
• International Research Center — Tampa, Florida, United States
• The Eyecare Institute/Butcherton Clinical Trials — Louisville, Kentucky, United States
• Rochester Ophthalmological Group PA — Rochester, New York, United States
• Abrams Eye Center — Cleveland, Ohio, United States
• Scott & Christie Associates PC — Cranberry Township, Pennsylvania, United States
• Total Eye Care P.A. — Memphis, Tennessee, United States
• Louis M. Alpern, M.D., M.P.H., P.A. — El Paso, Texas, United States
• Houston Eye Associates — Houston, Texas, United States
• R&R Research LLC — San Antonio, Texas, United States
• San Antonio Eye Center — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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