Limbal Stem Cell DeficiencyNCT07636590
Multi-Center, Prospective, Non-Interventional Study in Subjects With Limbal Stem Cell Deficiency
An observational study of Limbal Stem Cell Deficiency, run by Claris Biotherapeutics, Inc. at 8 sites in United States.
Trial summary
The goal of this non-interventional, observational study is to describe the natural history, clinical course, and management patterns of subjects with limbal stem cell deficiency (LSCD). Read more about this study
- Who is it for?
- Ages 12 to 99 years
- Conditions the study is for
- Limbal Stem Cell Deficiency
- What is being tested?
- Non-interventional
- How many people
- 500 participants
- Where
- 8 sitesUnited States
- Study dates
- 22 May 2026to Mar 2028
- Phase
- Observational
- 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 12 to 99 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Adult and adolescent subjects with qualifying LSCD
Who may be able to join
- A photopic BCVA in the prospective study eye(s) of ≤ 70 letters at the Screening and Day 1 visits AND a change of ≤ 10 letters in photopic BCVA at Day 1 compared to the Screening Visit
- Qualifying LSCD diagnosis in the study eye(s) prior to enrollment at Day 1
- Written confirmation that exclusions on retinal findings are met in the study eye(s) prior to enrollment at Day 1
- Inflammation associated with LSCD or other non-infectious inflammation (e.g., dry eye, ocular rosacea, and blepharitis) that will not interfere with the subject's participation in the opinion of the investigator is permitted.
Who cannot join
- Any active ocular infection in either eye at either the Screening or Day 1 visits
- Active sterile iritis or uveitis in either eye at Screening or Day 1 visits
- Screening visit retinal exam finding, in the opinion of the investigator, that would limit potential for visual acuity gain in the study eye(s)
- Note: Other inclusion/exclusion criteria apply.
Trial locations and contacts
8 sites in 1 country. Contact the study team or a site near you to ask about taking part.
8 sites in 1 country
United States8 sites, 8 recruiting
- Recruiting
Claris Investigative Site
Carmel, Indiana, 46290
Study Coordinator
919-205-0012
- Recruiting
Claris Investigative Site
Indianapolis, Indiana, 46260
Study Coordinator
919-205-0012
- Recruiting
Claris Investigative Site
Louisville, Kentucky, 40206
Study Coordinator
- Recruiting
Claris Investigative Site
Minnetonka, Minnesota, 53052
Study Coordinator
- Recruiting
Claris Investigative Site
Overland Park, Kansas, 66204
Study Coordinator
- Recruiting
Claris Investigative Site
Portland, Oregon, 97210
Study Coordinator
- Recruiting
Claris Investigative Site
San Antonio, Texas, 78212
Study Coordinator
- Recruiting
Claris Investigative Site
Smyrna, Tennessee, 37167
Study Coordinator
About this study
Official title: A Multi-Center, Prospective, Non-Interventional Study in Subjects With Limbal Stem Cell Deficiency
The goal of this non-interventional, observational study is to describe the natural history, clinical course, and management patterns of subjects with limbal stem cell deficiency (LSCD).
- Conditions
- Limbal Stem Cell Deficiency
- Being tested
- Non-interventional
- Medical subject headings
- Limbal Stem Cell Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-interventionalOther
Non-interventional
| Study group | Role | What they receive |
|---|---|---|
| Non-interventional | No product administration. Receives: Other: Non-interventional |
What is being measured
The primary outcome is the main question the study is designed to answer.
Natural Progression of LSCD as Assessed by Changes in Patient Reported Outcomes
Onset or changes (worsening or improving) in vision-related quality of life and ocular symptoms as captured with the National Eye Institute Visual Function Questionnaire-25 (VFQ-25) and Ocular Surface Disease Index (OSDI) questionnaires
Measured: Screening through Week 84
Natural Progression of LSCD as Assessed by Functional Changes (Photophobic BCVA)
Change in photophobic BCVA
Measured: Screening through Week 84
Natural Progression of LSCD as Assessed by Functional Changes (Low-luminance BCVA)
Change in low-luminance BCVA
Measured: Screening through Week 84
Natural Progression of LSCD as Assessed by Functional Changes (Low-contrast BCVA)
Change in low-contrast BCVA
Measured: Screening through Week 84
Natural Progression of LSCD as Assessed by Functional Changes (Contrast Sensitivity)
Change in contrast sensitivity (Pelli-Robson)
Measured: Screening through Week 84
Natural Progression of LSCD as Assessed by Anatomical/Structural Changes
Change in area of central cornea conjunctivalization
Measured: Screening through Week 84
Secondary outcomes (7)
Changes that May be Correlated with LSCD as Assessed by Functional Changes (Corneal Sensitivity)
Changes (onset, improvement, or worsening) in corneal sensitivity
Measured: Screening through Week 84
Changes that May be Correlated with LSCD as Assessed by Anatomical Changes (Corneal Topography/Tomography)
Changes (onset, improvement, or worsening) in corneal topography and/or tomography and/or densitometry
Measured: Screening through Week 84
Changes that May be Correlated with LSCD as Assessed by Anatomical Changes (Epithelial Defect Frequency)
Changes (onset, improvement, or worsening) in epithelial defect frequency
Measured: Screening through Week 84
Changes that May be Correlated with LSCD as Assessed by Anatomical Changes (Palisades of Vogt Crypts)
Changes (onset, improvement, or worsening) in Palisades of Vogt crypts
Measured: Screening through Week 84
Changes that May be Correlated with LSCD as Assessed by Anatomical Changes (Epithelial and Total Corneal Thickness)
Changes (onset, improvement, or worsening) in epithelial and total corneal thickness
Measured: Screening through Week 84
Changes that May be Correlated with LSCD as Assessed by Anatomical Changes (Pannus)
Changes (onset, improvement, or worsening) in pannus
Measured: Screening through Week 84
Changes that May be Correlated with LSCD as Assessed by Changes Ocular and Systemic Health Outcome Measures
Changes (onset, improvement/resolution, or worsening) of an existing condition
Measured: Screening through Week 84
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2026
- Study start22 May 2026
- Primary completionMar 2028 (estimated)
- Study completionMar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Limbal Stem Cell DeficiencyStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 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
- NCT07636590
- Sponsor's protocol ID
- CSB-C26-001
- Status last verified
- Aug 2026
- First submitted
- 3 Jun 2026
- Last updated
- 6 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Center, Prospective, Non-Interventional Study in Subjects With Limbal Stem Cell Deficiency
- ClinicalTrials.gov ID
- NCT07636590
- Acronym / sponsor ID
- CSB-C26-001
- Conditions
- Limbal Stem Cell Deficiency
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Claris Biotherapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 22 May 2026 (actual)
- Primary completion
- Mar 2028 (estimated)
- Study completion
- Mar 2028 (estimated)
- First posted
- 9 Jun 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.
The goal of this non-interventional, observational study is to describe the natural history, clinical course, and management patterns of subjects with limbal stem cell deficiency (LSCD).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Non-interventional | – | Other: Non-interventionalNo product administration. |
Who may qualify
- Ages
- 12 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Adult and adolescent subjects with qualifying LSCD
Key inclusion criteria (4 listed)
- A photopic BCVA in the prospective study eye(s) of ≤ 70 letters at the Screening and Day 1 visits AND a change of ≤ 10 letters in photopic BCVA at Day 1 compared to the Screening Visit
- Qualifying LSCD diagnosis in the study eye(s) prior to enrollment at Day 1
- Written confirmation that exclusions on retinal findings are met in the study eye(s) prior to enrollment at Day 1
- Inflammation associated with LSCD or other non-infectious inflammation (e.g., dry eye, ocular rosacea, and blepharitis) that will not interfere with the subject's participation in the opinion of the investigator is permitted.
Key exclusion criteria (4 listed)
- Any active ocular infection in either eye at either the Screening or Day 1 visits
- Active sterile iritis or uveitis in either eye at Screening or Day 1 visits
- Screening visit retinal exam finding, in the opinion of the investigator, that would limit potential for visual acuity gain in the study eye(s)
- Note: Other inclusion/exclusion criteria apply.
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 |
|---|---|---|
| Non-interventionalNon-interventional | Other | Non-interventional |
Primary outcome
Natural Progression of LSCD as Assessed by Changes in Patient Reported Outcomes
Time frame: Screening through Week 84
Onset or changes (worsening or improving) in vision-related quality of life and ocular symptoms as captured with the National Eye Institute Visual Function Questionnaire-25 (VFQ-25) and Ocular Surface Disease Index (OSDI) questionnaires
Natural Progression of LSCD as Assessed by Functional Changes (Photophobic BCVA)
Time frame: Screening through Week 84
Change in photophobic BCVA
Natural Progression of LSCD as Assessed by Functional Changes (Low-luminance BCVA)
Time frame: Screening through Week 84
Change in low-luminance BCVA
Natural Progression of LSCD as Assessed by Functional Changes (Low-contrast BCVA)
Time frame: Screening through Week 84
Change in low-contrast BCVA
Natural Progression of LSCD as Assessed by Functional Changes (Contrast Sensitivity)
Time frame: Screening through Week 84
Change in contrast sensitivity (Pelli-Robson)
Natural Progression of LSCD as Assessed by Anatomical/Structural Changes
Time frame: Screening through Week 84
Change in area of central cornea conjunctivalization
7 secondary outcomes
Changes that May be Correlated with LSCD as Assessed by Functional Changes (Corneal Sensitivity)
Time frame: Screening through Week 84
Changes that May be Correlated with LSCD as Assessed by Anatomical Changes (Corneal Topography/Tomography)
Time frame: Screening through Week 84
Changes that May be Correlated with LSCD as Assessed by Anatomical Changes (Epithelial Defect Frequency)
Time frame: Screening through Week 84
Changes that May be Correlated with LSCD as Assessed by Anatomical Changes (Palisades of Vogt Crypts)
Time frame: Screening through Week 84
Changes that May be Correlated with LSCD as Assessed by Anatomical Changes (Epithelial and Total Corneal Thickness)
Time frame: Screening through Week 84
Changes that May be Correlated with LSCD as Assessed by Anatomical Changes (Pannus)
Time frame: Screening through Week 84
Changes that May be Correlated with LSCD as Assessed by Changes Ocular and Systemic Health Outcome Measures
Time frame: Screening through Week 84
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 6 Aug 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.
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Limbal Stem Cell Deficiency, run by Claris Biotherapeutics, Inc. at 8 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 4 inclusion and 4 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 6 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 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.
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?
Natural Progression of LSCD as Assessed by Changes in Patient Reported Outcomes (time frame: Screening through Week 84). The study lists 6 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 6 Aug 2026.