Who is sponsoring TC-002-301?

TC-002-301 is sponsored by TearClear Corp.

What condition does TC-002-301 study?

TC-002-301 studies Elevated Intraocular Pressure.

What drugs are being tested in TC-002-301?

Interventions: Latanoprost ophthalmic solution, 0.005%, TC-002 latanoprost ophthalmic solution, 0.005%.

What is the status of TC-002-301?

TC-002-301 is currently UNKNOWN.

Last reviewed 2022-05-23 · How we verify

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 (TC-002-301)

NCT05165290 Phase 3 UNKNOWN

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

Details

Lead sponsor	TearClear Corp
Phase	Phase 3
Status	UNKNOWN
Enrolment	300
Start date	2021-11-29
Completion	2022-09

Conditions

Elevated Intraocular Pressure

Interventions

Latanoprost ophthalmic solution, 0.005%
TC-002 latanoprost ophthalmic solution, 0.005%

Primary outcomes

Primary efficacy endpoint is the difference in mean change from baseline (CFB) in IOP — Weeks 2, 6, and 12 at 8:00 AM, 10:00 AM, and 4:00 PM.

Countries

United States