NCT05165290

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: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 300 (estimated)
• Sponsor: TearClear Corp · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Detailed 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).

Conditions

• Elevated Intraocular Pressure

Interventions

Type	Name	Description
DRUG	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
DRUG	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.

Timeline

• Start date: 2021-11-29
• Primary completion: 2022-09-01
• Completion: 2022-09-01
• First posted: 2021-12-21
• Last updated: 2022-05-25

Locations

20 sites across 1 country: United States

Regulatory

• FDA-regulated drug study