Multi-Center, Prospective, Non-Interventional Study in Subjects With Limbal Stem Cell Deficiency

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).

Study Overview

• Status: Recruiting
• Conditions: Limbal Stem Cell Deficiency
• Intervention / Treatment: Other: Non-interventional

• Study Type: Observational
• Enrollment (Estimated): 500

Contacts and Locations

• Study Contact: Name: Central Operations Representative; Phone Number: 919-205-0012; Email: clinicaltrials@clarisbio.com

Study Locations

• United States
  • Indiana
    • Carmel, Indiana, United States, 46290
      • Recruiting
      • Midwest Cornea Associates, LLC
      • Contact: Study Coordinator
    • Indianapolis, Indiana, United States, 46260
      • Recruiting
      • Francis Price Jr, MD
      • Contact: Study Coordinator

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Adult and adolescent subjects with qualifying LSCD

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Non-interventional; No product administration.	Other: Non-interventional; Non-interventional

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes that May be Correlated with LSCD as Assessed by Functional Changes (Corneal Sensitivity)	Changes (onset, improvement, or worsening) in corneal sensitivity	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	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	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	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	Screening through Week 84
Changes that May be Correlated with LSCD as Assessed by Anatomical Changes (Pannus)	Changes (onset, improvement, or worsening) in pannus	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	Screening through Week 84

Collaborators and Investigators

• Sponsor: Claris Biotherapeutics, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): May 22, 2026
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): March 1, 2028

Study Registration Dates

• First Submitted: June 3, 2026
• First Submitted That Met QC Criteria: June 3, 2026
• First Posted (Actual): June 9, 2026

Study Record Updates

• Last Update Posted (Actual): June 9, 2026
• Last Update Submitted That Met QC Criteria: June 3, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Corneal Diseases; Limbal Stem Cell Deficiency
• Other Study ID Numbers: CSB-C26-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No