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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Non-interventional | No product administration. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Non-interventional | Other | Non-interventional |
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| 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 |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
Note: Other inclusion/exclusion criteria apply.
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Adult and adolescent subjects with qualifying LSCD
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Central Operations Representative | Contact | 919-205-0012 | clinicaltrials@clarisbio.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Midwest Cornea Associates, LLC | Recruiting | Carmel | Indiana | 46290 | United States |
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| ID | Term |
|---|---|
| D000092423 | Limbal Stem Cell Deficiency |
| ID | Term |
|---|---|
| D003316 | Corneal Diseases |
| D005128 | Eye Diseases |
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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 |
| Francis Price Jr, MD | Recruiting | Indianapolis | Indiana | 46260 | United States |
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