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

NCT07636590 · tracked via the Priya Life Science USA tracker

Sponsor

Claris Biotherapeutics, Inc.

Phase

Observational

Started

2026-05-22

Last updated

2026-08-06

Condition(s) studied

Limbal Stem Cell Deficiency

Investigational drug(s) / intervention(s)

Non-interventional

Non-interventional: Non-interventional

Study 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).

Eligibility

Sex

ALL

Min age

12 Years

Max age

99 Years

Healthy volunteers

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.

Primary outcome measure(s)

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

Trial sites (8)

Facility	City	Region	Status
Claris Investigative Site	Carmel	Indiana	Recruiting
Claris Investigative Site	Indianapolis	Indiana	Recruiting
Claris Investigative Site	Overland Park	Kansas	Recruiting
Claris Investigative Site	Louisville	Kentucky	Recruiting
Claris Investigative Site	Minnetonka	Minnesota	Recruiting
Claris Investigative Site	Portland	Oregon	Recruiting
Claris Investigative Site	Smyrna	Tennessee	Recruiting
Claris Investigative Site	San Antonio	Texas	Recruiting

More Claris Biotherapeutics, Inc. trials in the USA

Study to Evaluate the Safety and Efficacy of CSB-001 Ophthalmic Solution 0.1% in Subjects With Corneal Scars Recruiting

Study to Evaluate the Safety and Efficacy of CSB-001 Ophthalmic Solution 0.1% in Subjects With Limbal Stem Cell Deficiency Recruiting

Other trials for the same condition

Study to Evaluate the Safety and Efficacy of CSB-001 Ophthalmic Solution 0.1% in Subjects With Limbal Stem Cell Deficiency Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07636590 on ClinicalTrials.gov ↗ ← All trials in the USA