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
NCT ID: NCT05165290
Last Updated: 2022-05-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
300 participants
INTERVENTIONAL
2021-11-29
2022-09-30
Brief Summary
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Detailed Description
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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).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
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.
Study Groups
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LAT, 0.005%
Commercially available FDA-approved generic latanoprost ophthalmic solution, 0.005%
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
TC-002
TC-002, TearClear latanoprost ophthalmic solution, 0.005%
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.
Interventions
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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
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.
Eligibility Criteria
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Inclusion Criteria
2. Have been diagnosed and treated for bilateral open-angle glaucoma or ocular hypertension in both eyes.
3. 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.
4. 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.
5. 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.
6. In the Investigator's judgment, are able to safely discontinue current ocular hypotensive medication during the washout period.
7. Willing and able to avoid wearing contact lenses from Visit 1 (Screening) and for the duration of the trial.
8. Willing and able to self-administer or have an able person available on a daily basis to assist with administration of study medication.
9. 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.
10. Willing and able to comply with all study procedures.
Exclusion Criteria
1. narrow angles (3 quadrants with less than Grade 2 according to Shaffer anterior chamber angle grading system) and subjects with angle closure
2. clinically significant peripheral anterior synechiae
3. congenital glaucoma
4. a history of angle closure in either eye
5. aphakic glaucoma
6. traumatic glaucoma
7. neovascular glaucoma
8. pigmentary glaucoma
9. pseudoexfoliative glaucoma
10. drug-induced glaucoma
2. Using a multi-drop treatment (other than prostaglandin or prostaglandin analog) for IOP-lowering medications.
3. Advanced glaucoma or subjects with a cup/disc ratio greater than 0.8.
4. Have undergone incisional IOP-lowering surgeries a placement or removal of minimally invasive glaucoma implant (MIG) in either eye.
5. Have undergone non-incisional IOP-lowering surgeries within the past 6 months.
6. Used anti-vascular endothelial growth factor (anti-VEGF) within 12 months of screening.
7. Used intraocular, periocular or topical corticosteroids within 60 days of screening.
8. Have received laser surgery for glaucoma (selective laser trabeculoplasty \[SLT\] or argon laser trabeculoplasty \[ALT\]) within 6 months of screening.
9. Have uveitis, iritis or congenital aphakia.
10. Are unwilling to discontinue current glaucoma medication within 30 days of the randomization (Visit 2).
11. Have had intraocular or periocular surgery within the past 3 months.
12. Are non-responsive to topical prostaglandins, prostamides or prostaglandin analogs in the Investigator's judgement.
13. History of previous complicated cataract surgery, or previous refractive keratotomy in either eye.
14. Used miotics and oral/topical carbonic anhydrase inhibitors within 5 days of screening.
15. Have any known hypersensitivity to any components of the formulation or latanoprost.
16. Have participated in a clinical trial for IOP-lowering investigational product or exposure to an IP within the prior 30 days.
17. 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.
18 Years
ALL
No
Sponsors
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TearClear Corp
INDUSTRY
Responsible Party
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Locations
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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
Countries
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Other Identifiers
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TC-002-301
Identifier Type: -
Identifier Source: org_study_id
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