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RecruitingNCT07886268CapellionUpdated Oct 21, 2026

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

A Phase 2 interventional study of TP-06 and Vehicle of TP-06 in Persistent Corneal Epithelial Defect, sponsored by Tarsus Pharmaceuticals, Inc.. Recruiting at 14 sites in 4 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-21.

Sponsored by Tarsus Pharmaceuticals, Inc. · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Registered 5 months after the study started (first participant enrolled Apr 2026, registered Oct 2026).
  • Started Apr 2026; still recruiting 6 months later.
Updated Oct 21, 2026Newly registeredGo to Updates ↓
Phase
Phase 2
Study type
Interventional
Enrollment
32
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

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.

Read the detailed description

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.

02

Conditions studied

  • Persistent Corneal Epithelial Defect

Keywords

  • persistent corneal epithelial defect
  • PCED
  • corneal healing
  • vehicle-controlled
03

In context

Lead sponsor

Tarsus Pharmaceuticals, Inc. is the lead sponsor of 13 studies on the registry; 2 are open to participants now.

Of its 8 completed or terminated interventional studies of FDA-regulated products, 3 (38%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Able and willing to provide written
  • 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

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

Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
32 participants (estimated)

Study arms

  • Active comparator
    TP-06 Ophthalmic Solution

    Drug: TP-06

  • Placebo comparator
    Vehicle of TP-06 Ophthalmic Solution

    Drug: Vehicle of TP-06

Interventions

  • DrugTP-06

    TP-06 ophthalmic solution

  • DrugVehicle of TP-06

    Vehicle of TP-06 ophthalmic solution

06

What researchers measure

Primary outcomes

  1. Proportion of participants achieving complete resolution of corneal fluorescein staining (CFS) in the study eye at day 56, maintained through 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.

    Time frame: Day 56 and Day 70

Secondary outcomes

  1. Proportion of participants achieving complete resolution of CFS earlier than Day 56

    Time frame: Day 1 through Day 56

  2. 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

    Time frame: Day 1 through Day 56

  3. Time to achieve complete resolution of CFS within the original lesion area

    Time frame: Day 1 through Day 56

  4. Change from baseline in best-corrected visual acuity

    Time frame: Day 1 through Day 56

07

Study locations

6 of 14 sites recruiting
  • Tarsus Investigative Site
    Scottsdale, Arizona 36301, United States
    Not yet recruiting
  • Tarsus Investigative Site
    Tampa, Florida 33612, United States
    Not yet recruiting
  • Tarsus Investigative Site
    Atlanta, Georgia 30339, United States
    Recruiting
  • Tarsus Investigative Site
    Alexandria, Minnesota 56308, United States
    Recruiting
  • Tarsus Investigative Site
    Dover, New Jersey 07801, United States
    Not yet recruiting
  • Tarsus Investigative Site
    Palisades Park, New Jersey 07650, United States
    Not yet recruiting
  • Tarsus Investigative Site
    Babylon, New York 11702, United States
    Not yet recruiting
  • Tarsus Investigative Site
    Mt. Pleasant, South Carolina 29464, United States
    Not yet recruiting
  • Tarsus Investigative Site
    Houston, Texas 77008, United States
    Recruiting
  • Tarsus Investigative Site
    Sugar Land, Texas 77478, United States
    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
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

1 registry update since Sep 25, 2026
Registered
First appeared on the registry. No changes since
Oct 21, 2026
Show all 1 update
  1. Oct 21, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07886268
Lead sponsor
Tarsus Pharmaceuticals, Inc.
Responsible party
Sponsor
First posted
Oct 21, 2026
Start date
Apr 20, 2026
Primary completion
Jul 7, 2028 (estimated)
Completion
Jul 7, 2028 (estimated)
Last update
Oct 21, 2026

Study contacts

Study Director
Contact
clinical@tarsusrx.com
888-421-4002
Study Coordinator
Contact
888-421-4002

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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