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

Conditions

• Elevated Intraocular Pressure

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Latanoprost ophthalmic solution, 0.005% — DRUG
  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% — DRUG
  TC-002 is formulated using the commercially available latanoprost drug substance; delivered drop to the eye is preservative-free.

Study Details

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

Key Dates

First listed

Dec 21, 2021

Start date

Nov 29, 2021

Status verified

May 2022

Primary completion

Sep 30, 2022

Completion

Sep 30, 2022

Study Design

Enrollment

300 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: LAT, 0.005%
  Commercially available FDA-approved generic latanoprost ophthalmic solution, 0.005%
• Experimental: TC-002
  TC-002, TearClear latanoprost ophthalmic solution, 0.005%

Primary Outcome Measure

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. ]

Locations (20)

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