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
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
300
Commercially available, FDA-approved generic latanoprost ophthalmic solution, 0.005% (LAT) without modification will be used as the active control
TC-002 is formulated using the commercially available latanoprost drug substance; delivered drop to the eye is preservative-free.
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
...and 10 more locations
Primary efficacy endpoint is the difference in mean change from baseline (CFB) in IOP
Time frame: Weeks 2, 6, and 12 at 8:00 AM, 10:00 AM, and 4:00 PM.
Secondary efficacy endpoints include diurnal (average of 8:00 AM, 10:00 AM, and 4:00 PM measurements) IOP
Time frame: Weeks 2, 6, and 12.
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