Last updated 42 hours ago

A Study to Evaluate the Efficacy and Safety of TP-06 for PCED

32 patients around the world
Available in El Salvador, Mexico, United States
Capellion is a Phase 2, multicenter, randomized, double-masked, vehicle-controlled pilot trial in up to 32 adult Participants with persistent corneal epithelial defects (PCED) that have not completely healed after at least 10 days of standard-of-care treatment. Participants will be randomized 1:1 to receive TP-06 2.0% or Vehicle four times daily for 8 weeks, along with protocol-required background therapy, followed by a 2-week post-treatment period. The trial will evaluate the efficacy and safety of TP-06, including complete corneal healing, the timing and extent of healing, visual acuity, and changes in corneal thickness.
Tarsus Pharmaceuticals, Inc.
32Patients around the world

This study is for people with

Persistent Epithelial Defects

Requirements for the patient

From 18 Years
All Gender

Medical requirements

Able and willing to provide written informed consent.
Presence of a non-infected persistent corneal epithelial defect (PCED) in one eye that has failed to heal after at least 10 days of appropriate standard-of-care treatment.
Stable lesion size between Screening and Baseline as assessed by the Investigator.
Active ocular infection in either eye.
Corneal perforation or high risk of corneal perforation.
Severe eyelid abnormalities.
Ocular or eyelid surgery in the study eye within 3 months prior to Baseline (unless PCED was caused by surgery).
Use of prohibited ophthalmic medications or procedures as defined in the protocol.
Any condition that, in the Investigator's judgment, would interfere with study participation or interpretation of results.
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