Limbal Stem Cell Deficiency: Observational Look at How It Manages Over Time

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is an observational, non-interventional study conducted at multiple sites to describe the natural history, clinical course, and management patterns of subjects with limbal stem cell deficiency (LSCD). Eligible participants have LSCD with specific visual criteria and stable retinal findings, and may have non-infectious inflammation that does not interfere with participation. Data will be collected during routine clinical care to characterize outcomes and management approaches. The investigation is led by Claris Biotherapeutics with participation from three investigative sites in Indiana and Kansas. No active interventional therapies are administered as part of the protocol.

Why it matters

Who can join: the full rules

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.

Where it's running

• Claris Investigative Site
  Carmel, Indiana, United States Recruiting
• Claris Investigative Site
  Indianapolis, Indiana, United States Recruiting
• Claris Investigative Site
  Overland Park, Kansas, United States Recruiting
• Claris Investigative Site
  Louisville, Kentucky, United States Recruiting
• Claris Investigative Site
  Minnetonka, Minnesota, United States Recruiting
• Claris Investigative Site
  Portland, Oregon, United States Recruiting

Study contacts

• Study coordinator: Central Operations Representative
• Email: clinicaltrials@clarisbio.com
• Phone: 949-354-1299

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Limbal function and tear protein changes in glaucoma

  This study tests whether glaucoma and long-term glaucoma medicines change limbal stem cell–related corneal epithelial thickness and tear proteins in people with glaucoma, ocular hypertension, or healthy adults.

  Recruiting National Taiwan University Hospital · Hsinchu · NCT07119580

• Evaluating a new eye treatment for Limbal Stem Cell Deficiency

  This study is testing a new eye drop treatment for people with Limbal Stem Cell Deficiency to see if it is safe and helps improve their condition.

  Recruiting at 6 sites Phase 1 Claris Biotherapeutics, Inc. · Loma Linda, California and 5 other locations · NCT06452316

• Using cultured corneal cells to treat limbal stem cell deficiency

  This study is testing if transplanting specially grown corneal cells can help people with limbal stem cell deficiency improve their eye health and vision.

  Recruiting at 4 sites CHU de Quebec-Universite Laval · Toronto, Ontario and 3 other locations · NCT01756365

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.