Eye Research Foundation | Newport Beach, CA
Status and phase
Conditions
Treatments
About
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
Full 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).
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Exclusion criteria
Causes of glaucoma other than primary open-angle glaucoma, including:
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.
Primary purpose
Allocation
Interventional model
Masking
300 participants in 2 patient groups
Loading...
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal