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

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.

• TP-06 (Drug): TP-06 ophthalmic solution
• Vehicle of TP-06 (Drug): Vehicle of TP-06 ophthalmic solution

Primary outcomes

• Proportion of participants achieving complete resolution of corneal fluorescein staining (CFS) in the study eye at day 56, maintained through day 70. [Day 56 and Day 70]: A participant will be considered to have achieved complete resolution of CFS when there is no residual fluorescein staining at the time of assessment and at the follow-up assessment.

Secondary outcomes

• Proportion of participants achieving complete resolution of CFS earlier than Day 56 [Day 1 through Day 56]
• Change from başeline in lesion size (area in mm2) in the study eye using images of fluorescein staining of cornea evaluated by imaging reading center [Day 1 through Day 56]
• Time to achieve complete resolution of CFS within the original lesion area [Day 1 through Day 56]
• Change from baseline in best-corrected visual acuity [Day 1 through Day 56]

Sex: All, ages: 18 Years to any

Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Note: Additional exclusion criteria apply, as defined in the protocol