Limbal Stem Cell Deficiency
Conditions
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).
Interventions
OTHERNon-interventional
Non-interventional
Sponsors
Claris Biotherapeutics, Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
12 Years to 99 Years
Healthy volunteers
No
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/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Natural Progression of LSCD as Assessed by Changes in Patient Reported Outcomes | 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) | Screening through Week 84 | Change in photophobic BCVA |
| Natural Progression of LSCD as Assessed by Functional Changes (Low-luminance BCVA) | Screening through Week 84 | Change in low-luminance BCVA |
| Natural Progression of LSCD as Assessed by Functional Changes (Low-contrast BCVA) | Screening through Week 84 | Change in low-contrast BCVA |
| Natural Progression of LSCD as Assessed by Functional Changes (Contrast Sensitivity) | Screening through Week 84 | Change in contrast sensitivity (Pelli-Robson) |
| Natural Progression of LSCD as Assessed by Anatomical/Structural Changes | Screening through Week 84 | Change in area of central cornea conjunctivalization |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes that May be Correlated with LSCD as Assessed by Functional Changes (Corneal Sensitivity) | Screening through Week 84 | Changes (onset, improvement, or worsening) in corneal sensitivity |
| Changes that May be Correlated with LSCD as Assessed by Anatomical Changes (Corneal Topography/Tomography) | Screening through Week 84 | Changes (onset, improvement, or worsening) in corneal topography and/or tomography and/or densitometry |
| Changes that May be Correlated with LSCD as Assessed by Anatomical Changes (Epithelial Defect Frequency) | Screening through Week 84 | Changes (onset, improvement, or worsening) in epithelial defect frequency |
| Changes that May be Correlated with LSCD as Assessed by Anatomical Changes (Palisades of Vogt Crypts) | Screening through Week 84 | Changes (onset, improvement, or worsening) in Palisades of Vogt crypts |
| Changes that May be Correlated with LSCD as Assessed by Anatomical Changes (Epithelial and Total Corneal Thickness) | Screening through Week 84 | Changes (onset, improvement, or worsening) in epithelial and total corneal thickness |
| Changes that May be Correlated with LSCD as Assessed by Anatomical Changes (Pannus) | Screening through Week 84 | Changes (onset, improvement, or worsening) in pannus |
| Changes that May be Correlated with LSCD as Assessed by Changes Ocular and Systemic Health Outcome Measures | Screening through Week 84 | Changes (onset, improvement/resolution, or worsening) of an existing condition |
Countries
United States
Contacts
CONTACTCentral Operations Representative
Outcome results
None listed