Corneal ScarPhase 1NCT06257355
Study to Evaluate the Safety and Efficacy of CSB-001 Ophthalmic Solution 0.1% in Subjects With Corneal Scars
A Phase 1 study testing CSB-001 Ophthalmic Solution 0.1% in people with Corneal Scar, run by Claris Biotherapeutics, Inc. at 7 sites in United States.
Trial summary
This study will enroll subjects with recently formed corneal scars that resulted from a corneal insult presenting and diagnosed within the past approximately 30 days and not less than approximately 7 days. All subjects will be assigned to CSB-001 investigational treatment on Day 1. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Corneal Scar
- What is being tested?
- CSB-001 Ophthalmic Solution 0.1%
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 7 sitesUnited States
- Study dates
- 5 Feb 2024to 30 Jun 2027
- Phase
- Phase 1
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Centrally or paracentrally located scar approximately ≤5 mm and ≥2 mm in the greatest diameter and with a portion of the scar within approximately 3.5 mm of the optical center of the cornea assessed at Screening and confirmed at Baseline, and subject reports ability to detect any effect of scar on any element of vision.
- Eye with a recent corneal insult approximately ≤30 days and ≥7 days from the Screening Visit.
- Corneal insult includes but is not limited to mechanical / chemical / thermal injury, bacterial keratitis, PRK, and contact lens related ulcer.
- Eye with observed rate of epithelialization that in the investigator's opinion does not demonstrate clinical characteristics of a slow healing (persistent defect) cornea.
- Subjects must have the ability and willingness to comply with study procedures.
Who cannot join
- Corneal scar that encompasses more than approximately 50% of the depth of the remaining stroma as guided by ASOCT image at the Screening Visit.
- Maximum scar diameter greater than approximately 5 mm without prior approval by the Sponsor based on Screening Visit images.
- No portion of the scar is within the approximate 3.5 mm of the optical center of the cornea based on Screening Visit images.
- Any active ocular infection in the opinion of the investigator (bacterial, viral, fungal, or protozoal) at the Screening or Day 1 Visits. Subjects with an active bacterial infection at the Screening or Day 1 Visit in the opinion of the investigator may be rescheduled to reassess the status of the infection and continue in the study if infection is deemed not active.
- Ocular surgery planned during the study treatment period.
- Presence or history of any ocular or systemic disorder, condition or procedure that might hinder the efficacy of the study treatment or its evaluation, could possibly interfere with the interpretation of study results, or could be judged by the investigator to be incompatible with the study visit schedule or conduct.
- Note: Other inclusion/exclusion criteria apply.
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
United States7 sites, 7 recruiting
- Recruiting
Midwest Cornea Associates, LLC
Carmel, Indiana, 46290
Study Coordinator
- Recruiting
Francis Price Jr, MD
Indianapolis, Indiana, 46260
Study Coordinator
- Recruiting
Loma Linda University Eye Institute
Loma Linda, California, 92354
Study Coordinator
- Recruiting
Minnesota Eye Consultants
Minnetonka, Minnesota, 55305
Study Coordinator
- Recruiting
Virginia Eye Consultants
Norfolk, Virginia, 23502
Study Coordinator
- Recruiting
Legacy Devers Eye Institute
Portland, Oregon, 97210
Study Coordinator
- Recruiting
Stuart A. Terry, MD PA
San Antonio, Texas, 78212
Study Coordinator
About this study
Official title: A Two-Arm Open-Label Study to Evaluate the Safety and Efficacy of CSB-001 Ophthalmic Solution 0.1% in Subjects With Corneal Scars
This study will enroll subjects with recently formed corneal scars that resulted from a corneal insult presenting and diagnosed within the past approximately 30 days and not less than approximately 7 days. All subjects will be assigned to CSB-001 investigational treatment on Day 1. All subjects will dose with CSB-001 four times daily or three times daily starting on Day 1 and continue until Day 14. Subjects with a resolved scar at Day 7 will discontinue dosing and return to the clinic on Day 14. Subjects will return on Days 21, 28, 56, and Month 3 for safety and efficacy assessments.
- Conditions
- Corneal Scar
- Being tested
- CSB-001 Ophthalmic Solution 0.1%
- Medical subject headings
- Corneal Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CSB-001 Ophthalmic Solution 0.1%Biological
CSB-001: human recombinant dHGF (5-amino acid deleted hepatocyte growth factor)
| Study group | Role | What they receive |
|---|---|---|
| CSB-001 QID | Experimental | One drop CSB-001 four times daily for 14 days in the study eye Receives: Biological: CSB-001 Ophthalmic Solution 0.1% |
| CSB-001 TID | Experimental | One drop CSB-001 three times daily for 14 days in the study eye Receives: Biological: CSB-001 Ophthalmic Solution 0.1% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety as Assessed by Adverse Event Reporting
Incidence of ocular and systemic adverse events
Measured: Day 1 through Day 56
Safety as Assessed by Slit-lamp Biomicroscopy
Change from baseline in staining using NEI scale (0 = absent to 3 = severe for 5 areas of the cornea) with Grade 0 (no staining) to maximum of Grade 15
Measured: Screening through Day 56
Safety as Assessed by Best-Corrected Distance Visual Acuity
Change from baseline using the Early Treatment Diabetic Retinopathy Study (EDTRS) visual acuity chart
Measured: Screening through Day 56
Secondary outcomes (6)
Efficacy as Assessed by Area of Corneal Scar
Area of corneal scar as measured by slit lamp and anterior segment optical coherence tomography (AS-OCT) imaging
Measured: Screening through Day 56
Efficacy as Assessed by Maximum Depth of Cornea Scar
Depth measured with AS-OCT imaging
Measured: Screening through Day 56
Efficacy as Assessed by Volume of Scar
Volume measured with AS-OCT imaging
Measured: Screening through Day 56
Efficacy as Assessed by Density of Scar
Density based on AS-OCT and Pentacam imaging
Measured: Screening through Day 56
Efficacy as Assessed by Contrast Sensitivity
Contrast sensitivity measured using Pelli-Robson chart
Measured: Screening through Day 56
Efficacy as Assessed by Distance Visual Acuity
Visual acuity measured using the EDTRS visual acuity chart
Measured: Screening 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 posted13 Feb 2024
- Study start5 Feb 2024
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Corneal ScarStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Claris Biotherapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06257355
- Sponsor's protocol ID
- CSB-C23-002
- Status last verified
- Apr 2026
- First submitted
- 6 Feb 2024
- Last updated
- 7 Apr 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 7 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Two-Arm Open-Label Study to Evaluate the Safety and Efficacy of CSB-001 Ophthalmic Solution 0.1% in Subjects With Corneal Scars
- ClinicalTrials.gov ID
- NCT06257355
- Acronym / sponsor ID
- CSB-C23-002
- Conditions
- Corneal Scar
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Claris Biotherapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 5 Feb 2024 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 13 Feb 2024 (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.
This study will enroll subjects with recently formed corneal scars that resulted from a corneal insult presenting and diagnosed within the past approximately 30 days and not less than approximately 7 days. All subjects will be assigned to CSB-001 investigational treatment on Day 1. All subjects will dose with CSB-001 four times daily or three times daily starting on Day 1 and continue until Day 14. Subjects with a resolved scar at Day 7 will discontinue dosing and return to the clinic on Day 14. Subjects will return on Days 21, 28, 56, and Month 3 for safety and efficacy assessments.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CSB-001 QID | Experimental | Biological: CSB-001 Ophthalmic Solution 0.1%One drop CSB-001 four times daily for 14 days in the study eye |
| CSB-001 TID | Experimental | Biological: CSB-001 Ophthalmic Solution 0.1%One drop CSB-001 three times daily for 14 days in the study eye |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Centrally or paracentrally located scar approximately ≤5 mm and ≥2 mm in the greatest diameter and with a portion of the scar within approximately 3.5 mm of the optical center of the cornea assessed at Screening and confirmed at Baseline, and subject reports ability to detect any effect of scar on any element of vision.
- Eye with a recent corneal insult approximately ≤30 days and ≥7 days from the Screening Visit.
- Corneal insult includes but is not limited to mechanical / chemical / thermal injury, bacterial keratitis, PRK, and contact lens related ulcer.
- Eye with observed rate of epithelialization that in the investigator's opinion does not demonstrate clinical characteristics of a slow healing (persistent defect) cornea.
- Subjects must have the ability and willingness to comply with study procedures.
Key exclusion criteria (7 listed)
- Corneal scar that encompasses more than approximately 50% of the depth of the remaining stroma as guided by ASOCT image at the Screening Visit.
- Maximum scar diameter greater than approximately 5 mm without prior approval by the Sponsor based on Screening Visit images.
- No portion of the scar is within the approximate 3.5 mm of the optical center of the cornea based on Screening Visit images.
- Any active ocular infection in the opinion of the investigator (bacterial, viral, fungal, or protozoal) at the Screening or Day 1 Visits. Subjects with an active bacterial infection at the Screening or Day 1 Visit in the opinion of the investigator may be rescheduled to reassess the status of the infection and continue in the study if infection is deemed not active.
- Ocular surgery planned during the study treatment period.
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 |
|---|---|---|
| CSB-001 Ophthalmic Solution 0.1%CSB-001: human recombinant dHGF (5-amino acid deleted hepatocyte growth factor) | Biological | CSB-001 QID, CSB-001 TID |
Primary outcome
Safety as Assessed by Adverse Event Reporting
Time frame: Day 1 through Day 56
Incidence of ocular and systemic adverse events
Safety as Assessed by Slit-lamp Biomicroscopy
Time frame: Screening through Day 56
Change from baseline in staining using NEI scale (0 = absent to 3 = severe for 5 areas of the cornea) with Grade 0 (no staining) to maximum of Grade 15
Safety as Assessed by Best-Corrected Distance Visual Acuity
Time frame: Screening through Day 56
Change from baseline using the Early Treatment Diabetic Retinopathy Study (EDTRS) visual acuity chart
6 secondary outcomes
Efficacy as Assessed by Area of Corneal Scar
Time frame: Screening through Day 56
Efficacy as Assessed by Maximum Depth of Cornea Scar
Time frame: Screening through Day 56
Efficacy as Assessed by Volume of Scar
Time frame: Screening through Day 56
Efficacy as Assessed by Density of Scar
Time frame: Screening through Day 56
Efficacy as Assessed by Contrast Sensitivity
Time frame: Screening through Day 56
Efficacy as Assessed by Distance Visual Acuity
Time frame: Screening 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 7 Apr 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.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CSB-001 Ophthalmic Solution 0.1% in people with Corneal Scar, run by Claris Biotherapeutics, Inc. at 7 sites in United States.
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 5 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 7 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. 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. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 Central Operations Representative (949-354-1299, clinicaltrials@clarisbio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety as Assessed by Adverse Event Reporting (time frame: Day 1 through Day 56). The study lists 3 primary outcomes in all. 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 7 Apr 2026.