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TearClear’s TC-002 Latanoprost Ophthalmic Solution begins Phase 3 trial

Article

The removal of preservatives may be beneficial for the ocular health of glaucoma patients

TearClear announced the successful start of its Phase 3 clinical trial for its lead product candidate, Latanoprost OTO. The trial (CLEAR study) is a double-masked, randomized, multi-center, active-controlled, parallel-group study spanning 3 months. It is designed to evaluate the ocular hypotensive efficacy and safety of TC-002 Ophthalmic Solution (TearClear Preservative-Free Latanoprost Ophthalmic Solution 0.005%) compared to marketed Latanoprost Ophthalmic Solution 0.005%.

TearClear's platform is designed to enable the delivery of preservative-free solutions to the eye. Currently, around 30% to 40% of chronic glaucoma patients, who rely on preserved drugs, show signs of moderate to severe Ocular Surface Disease (OSD), according to the company.1

“Up until now, the preservative-free options available to patient are accompanied with compromises related to cost and ease of use,” says Thomas Samuelson, MD at Minnesota Eye Consultants. “TearClear’s approach offers patients the best of both worlds, where preservatives remain in the bottle but kept off the ocular surface.”

To date, TearClear is the first and only company to develop products that deliver preservative-free drops to the eye while maintaining BAK preserved formulations in the bottle.

Stuart Raetzman, TearClear’s CEO says, “Enrolling the first subjects is an important milestone.”

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