Clinical Trials in the USA / NCT07886268
Recruiting
Phase 2
A Study to Evaluate the Efficacy and Safety of TP-06 for PCED
NCT07886268 · tracked via the Priya Life Science USA tracker
Condition(s) studied
Persistent Corneal Epithelial Defect
Investigational drug(s) / intervention(s)
TP-06Vehicle of TP-06
TP-06: TP-06 ophthalmic solution
Vehicle of TP-06: Vehicle of TP-06 ophthalmic solution
Study summary
Capellion is a Phase 2 trial comparing TP-06 2.0% with Vehicle in up to 32 adults with persistent corneal epithelial defects. Participants will receive treatment for 8 weeks and be followed for 2 additional weeks to assess corneal healing and safety.
Eligibility
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
Primary outcome measure(s)
- 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.
Trial sites (14)
| Facility | City | Region | Status |
|---|---|---|---|
| Tarsus Investigative Site | Scottsdale | Arizona | Not Yet Recruiting |
| Tarsus Investigative Site | Tampa | Florida | Not Yet Recruiting |
| Tarsus Investigative Site | Atlanta | Georgia | Recruiting |
| Tarsus Investigative Site | Alexandria | Minnesota | Recruiting |
| Tarsus Investigative Site | Dover | New Jersey | Not Yet Recruiting |
| Tarsus Investigative Site | Palisades Park | New Jersey | Not Yet Recruiting |
| Tarsus Investigative Site | Babylon | New York | Not Yet Recruiting |
| Tarsus Investigative Site | Mt. Pleasant | South Carolina | Not Yet Recruiting |
| Tarsus Investigative Site | Houston | Texas | Recruiting |
| Tarsus Investigative Site | Sugar Land | Texas | Recruiting |
| Tarsus Investigative Site | Santo Domingo | Dominican Republic | Recruiting |
| Tarsus Investigative Site | San Salvador | El Salvador | Recruiting |
| Tarsus Investigative Site | Mexico City | Mexico | Not Yet Recruiting |
| Tarsus Investigative Site | Monterrey | Mexico | Not Yet Recruiting |
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Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07886268 on ClinicalTrials.gov ↗ ← All trials in the USA