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

Claris Biotherapeutics, Inc.500 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

500

Conditions

Limbal Stem Cell Deficiency

Interventions

Non-interventionalOTHER

Non-interventional

Eligibility

Sex: ALLMin age: 12 YearsMax age: 99 Years

Medical Language ↔ Plain English

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.

Locations (8)

Claris Investigative Site

Carmel, Indiana, United States

RECRUITING

Claris Investigative Site

Indianapolis, Indiana, United States

RECRUITING

Claris Investigative Site

Overland Park, Kansas, United States

Outcomes

Primary Outcomes

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