NCT07636590

Brief 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).

Trial Health

77
On Track

Trial Health Score

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

Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
21mo left

Started May 2026

Geographic Reach
1 country

2 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 Progress4%
May 2026Mar 2028

Study Start

First participant enrolled

May 22, 2026

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

June 3, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 9, 2026

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2028

Last Updated

June 9, 2026

Status Verified

May 1, 2026

Enrollment Period

1.8 years

First QC Date

June 3, 2026

Last Update Submit

June 3, 2026

Conditions

Limbal Stem Cell Deficiency

Outcome Measures

Primary Outcomes (6)

  • 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

    Screening through Week 84

  • Natural Progression of LSCD as Assessed by Functional Changes (Photophobic BCVA)

    Change in photophobic BCVA

    Screening through Week 84

  • Natural Progression of LSCD as Assessed by Functional Changes (Low-luminance BCVA)

    Change in low-luminance BCVA

    Screening through Week 84

  • Natural Progression of LSCD as Assessed by Functional Changes (Low-contrast BCVA)

    Change in low-contrast BCVA

    Screening through Week 84

  • Natural Progression of LSCD as Assessed by Functional Changes (Contrast Sensitivity)

    Change in contrast sensitivity (Pelli-Robson)

    Screening through Week 84

  • Natural Progression of LSCD as Assessed by Anatomical/Structural Changes

    Change in area of central cornea conjunctivalization

    Screening through Week 84

Secondary Outcomes (7)

  • Changes that May be Correlated with LSCD as Assessed by Functional Changes (Corneal Sensitivity)

    Screening through Week 84

  • Changes that May be Correlated with LSCD as Assessed by Anatomical Changes (Corneal Topography/Tomography)

    Screening through Week 84

  • Changes that May be Correlated with LSCD as Assessed by Anatomical Changes (Epithelial Defect Frequency)

    Screening through Week 84

  • Changes that May be Correlated with LSCD as Assessed by Anatomical Changes (Palisades of Vogt Crypts)

    Screening through Week 84

  • Changes that May be Correlated with LSCD as Assessed by Anatomical Changes (Epithelial and Total Corneal Thickness)

    Screening through Week 84

  • +2 more secondary outcomes

Study Arms (1)

Non-interventional

No product administration.

Other: Non-interventional

Interventions

Non-interventionalOTHER

Non-interventional

Non-interventional

Eligibility Criteria

Age12 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Adult and adolescent subjects with qualifying LSCD

You may qualify if:

  • 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
  • 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.

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Midwest Cornea Associates, LLC

Carmel, Indiana, 46290, United States

RECRUITING

Francis Price Jr, MD

Indianapolis, Indiana, 46260, United States

RECRUITING

MeSH Terms

Conditions

Limbal Stem Cell Deficiency

Condition Hierarchy (Ancestors)

Corneal DiseasesEye Diseases

Central Study Contacts

Central Operations Representative

CONTACT

919-205-0012clinicaltrials@clarisbio.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 3, 2026

First Posted

June 9, 2026

Study Start

May 22, 2026

Primary Completion (Estimated)

March 1, 2028

Study Completion (Estimated)

March 1, 2028

Last Updated

June 9, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Locations

US(2)