NCT07886268

Brief 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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for phase_2

Timeline
21mo left

Started Apr 2026

Geographic Reach
4 countries

14 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress23%
Apr 2026Jul 2028

Study Start

First participant enrolled

April 20, 2026

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

October 5, 2026

Completed
16 days until next milestone

First Posted

Study publicly available on registry

October 21, 2026

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 7, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 7, 2028

Last Updated

October 21, 2026

Status Verified

October 1, 2026

Enrollment Period

2.2 years

First QC Date

October 5, 2026

Last Update Submit

October 17, 2026

Conditions

Persistent Corneal Epithelial Defect

Keywords

persistent corneal epithelial defectPCEDcorneal healingvehicle-controlled

Outcome Measures

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.

    Day 56 and Day 70

Secondary Outcomes (4)

  • 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

Study Arms (2)

TP-06 Ophthalmic Solution

ACTIVE COMPARATOR
Drug: TP-06

Vehicle of TP-06 Ophthalmic Solution

PLACEBO COMPARATOR
Drug: Vehicle of TP-06

Interventions

TP-06DRUG

TP-06 ophthalmic solution

TP-06 Ophthalmic Solution
Vehicle of TP-06DRUG

Vehicle of TP-06 ophthalmic solution

Vehicle of TP-06 Ophthalmic Solution

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (14)

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

Central Study Contacts

Study Director

CONTACT

888-421-4002clinical@tarsusrx.com

Study Coordinator

CONTACT

888-421-4002

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 5, 2026

First Posted

October 21, 2026

Study Start

April 20, 2026

Primary Completion (Estimated)

July 7, 2028

Study Completion (Estimated)

July 7, 2028

Last Updated

October 21, 2026

Record last verified: 2026-10

Data Sharing

IPD Sharing
Will not share

Locations

US(10)DO(1)EL(1)ME(2)