Persistent Corneal Epithelial DefectPhase 2CapellionNCT07886268
A Study to Evaluate the Efficacy and Safety of TP-06 for PCED
A Phase 2 study testing TP-06 in people with Persistent Corneal Epithelial Defect, run by Tarsus Pharmaceuticals, Inc. at 14 sites in 4 countries.
Trial 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 more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Persistent Corneal Epithelial Defect
- What is being tested?
- TP-06
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 14 sitesin 4 countries
- Study dates
- 20 Apr 2026to 7 Jul 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
14 sites in 4 countries. Contact the study team or a site near you to ask about taking part.
Study Coordinator contact
14 sites in 4 countries
United States10 sites, 10 recruiting
- Recruiting
Tarsus Investigative Site
Alexandria, Minnesota, 56308
- Recruiting
Tarsus Investigative Site
Atlanta, Georgia, 30339
- Not yet recruiting
Tarsus Investigative Site
Babylon, New York, 11702
- Not yet recruiting
Tarsus Investigative Site
Dover, New Jersey, 07801
- Recruiting
Tarsus Investigative Site
Houston, Texas, 77008
- Not yet recruiting
Tarsus Investigative Site
Mt. Pleasant, South Carolina, 29464
- Not yet recruiting
Tarsus Investigative Site
Palisades Park, New Jersey, 07650
- Not yet recruiting
Tarsus Investigative Site
Scottsdale, Arizona, 36301
- Recruiting
Tarsus Investigative Site
Sugar Land, Texas, 77478
- Not yet recruiting
Tarsus Investigative Site
Tampa, Florida, 33612
Mexico2 sites, 2 recruiting
- Not yet recruiting
Tarsus Investigative Site
Mexico City
- Not yet recruiting
Tarsus Investigative Site
Monterrey
Dominican Republic1 site, 1 recruiting
- Recruiting
Tarsus Investigative Site
Santo Domingo
El Salvador1 site, 1 recruiting
- Recruiting
Tarsus Investigative Site
San Salvador
About this study
Official title: A Multicenter, Randomized, Double-Masked, Vehicle Controlled Study to Assess the Efficacy and Safety of TP-06 in Participants With Persistent Corneal Epithelial Defects
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.
- Conditions
- Persistent Corneal Epithelial Defect
- Being tested
- TP-06, Vehicle of TP-06
- Keywords
- persistent corneal epithelial defect, PCED, corneal healing, vehicle-controlled
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TP-06Drug
TP-06 ophthalmic solution
Vehicle of TP-06Drug
Vehicle of TP-06 ophthalmic solution
| Study group | Role | What they receive |
|---|---|---|
| TP-06 Ophthalmic Solution | Active comparator | Not described Receives: Drug: TP-06 |
| Vehicle of TP-06 Ophthalmic Solution | Placebo comparator | Not described Receives: Drug: Vehicle of TP-06 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 56 and Day 70
Secondary outcomes (4)
Proportion of participants achieving complete resolution of CFS earlier than Day 56
Measured: 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
Measured: Day 1 through Day 56
Time to achieve complete resolution of CFS within the original lesion area
Measured: Day 1 through Day 56
Change from baseline in best-corrected visual acuity
Measured: Day 1 through Day 56
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2026
- Study start20 Apr 2026
- Primary completion7 Jul 2028 (estimated)
- Study completion7 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Persistent Corneal Epithelial DefectStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tarsus Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07886268
- Sponsor's protocol ID
- TRS-028
- Acronym
- Capellion
- Status last verified
- Oct 2026
- First submitted
- 5 Oct 2026
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-Masked, Vehicle Controlled Study to Assess the Efficacy and Safety of TP-06 in Participants With Persistent Corneal Epithelial Defects
- ClinicalTrials.gov ID
- NCT07886268
- Acronym / sponsor ID
- Capellion / TRS-028
- Conditions
- Persistent Corneal Epithelial Defect
- Keywords
- persistent corneal epithelial defect, PCED, corneal healing, vehicle-controlled
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Tarsus Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- 20 Apr 2026 (actual)
- Primary completion
- 7 Jul 2028 (estimated)
- Study completion
- 7 Jul 2028 (estimated)
- First posted
- 21 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TP-06 Ophthalmic Solution | Active comparator | Drug: TP-06 |
| Vehicle of TP-06 Ophthalmic Solution | Placebo comparator | Drug: Vehicle of TP-06 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TP-06TP-06 ophthalmic solution | Drug | TP-06 Ophthalmic Solution |
| Vehicle of TP-06Vehicle of TP-06 ophthalmic solution | Drug | Vehicle of TP-06 Ophthalmic Solution |
Primary outcome
Proportion of participants achieving complete resolution of corneal fluorescein staining (CFS) in the study eye at day 56, maintained through day 70.
Time frame: 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.
4 secondary outcomes
Proportion of participants achieving complete resolution of CFS earlier than Day 56
Time frame: 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
Time frame: Day 1 through Day 56
Time to achieve complete resolution of CFS within the original lesion area
Time frame: Day 1 through Day 56
Change from baseline in best-corrected visual acuity
Time frame: Day 1 through Day 56
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Study Coordinator contact
14 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing TP-06 in people with Persistent Corneal Epithelial Defect, run by Tarsus Pharmaceuticals, Inc. at 14 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in United States, Mexico, Dominican Republic, El Salvador. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Study Director (888-421-4002, clinical@tarsusrx.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of participants achieving complete resolution of corneal fluorescein staining (CFS) in the study eye at day 56, maintained through day 70. (time frame: Day 56 and Day 70). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2026.