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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age12-99
SponsorClaris Biotherapeutics, Inc.

About this trial

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 criteria

Qualifiers

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.

Disqualifiers

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)

Trial design

Treatments tested in this trial

  • Non-interventional

Treatment groups

500 Participants
are divided into 1 treatment group

Sponsors and collaborators