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NCT Number: NCT07636590

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).

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Key information

Conditions

Limbal Stem Cell Deficiency Corneal Diseases Eye Diseases

Age range

12 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Claris Investigative Site, Carmel, Indiana, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Non-Interventional

Other

Non-interventional

Primary outcomes

  1. 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

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

    Time frame: Screening through Week 84

    Change in photophobic BCVA

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

    Time frame: Screening through Week 84

    Change in low-luminance BCVA

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

    Time frame: Screening through Week 84

    Change in low-contrast BCVA

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

    Time frame: Screening through Week 84

    Change in contrast sensitivity (Pelli-Robson)

  6. Natural Progression of LSCD as Assessed by Anatomical/Structural Changes

    Time frame: Screening through Week 84

    Change in area of central cornea conjunctivalization

Secondary outcomes

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

    Time frame: Screening through Week 84

    Changes (onset, improvement, or worsening) in corneal sensitivity

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

    Time frame: Screening through Week 84

    Changes (onset, improvement, or worsening) in corneal topography and/or tomography and/or densitometry

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

    Time frame: Screening through Week 84

    Changes (onset, improvement, or worsening) in epithelial defect frequency

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

    Time frame: Screening through Week 84

    Changes (onset, improvement, or worsening) in Palisades of Vogt crypts

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

    Time frame: Screening through Week 84

    Changes (onset, improvement, or worsening) in epithelial and total corneal thickness

  6. Changes that May be Correlated with LSCD as Assessed by Anatomical Changes (Pannus)

    Time frame: Screening through Week 84

    Changes (onset, improvement, or worsening) in pannus

  7. Changes that May be Correlated with LSCD as Assessed by Changes Ocular and Systemic Health Outcome Measures

    Time frame: Screening through Week 84

    Changes (onset, improvement/resolution, or worsening) of an existing condition

Study contacts

Contact information is provided by the study sponsor or research team.

Central Operations Representative

CONTACT

[email protected]

919-205-0012

Sponsors and collaborators

Lead sponsor

Claris Biotherapeutics, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Jun 9, 2026
Registry last updated
Jul 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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