Recruiting

Limbal Stem Cell Deficiency

Sponsor:

Claris Biotherapeutics, Inc.

Code:

NCT07636590

Conditions

Limbal Stem Cell Deficiency

Eligibility Criteria

Sex: All

Age: 12 - 70+

Healthy Volunteers: Not accepted

Interventions

Non-interventional

Study Details

Brief 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).

Conditions

Limbal Stem Cell Deficiency

Study ID

NCT07636590

Start date

May 22, 2026

Status verified date

Aug, 2026

Completion date

Mar, 2028

Anticipated

Primary completion date

Mar, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 12 - 70+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

500 participants

Anticipated

Interventions and Outcome Measures

Arms

Non-interventional

No product administration.

Interventions

Non-interventional

Non-interventional

Primary outcome measure

  • Natural Progression of LSCD as Assessed by Changes in Patient Reported Outcomes [ Time Frame: Screening through Week 84 ]
  • Natural Progression of LSCD as Assessed by Functional Changes (Photophobic BCVA) [ Time Frame: Screening through Week 84 ]
  • Natural Progression of LSCD as Assessed by Functional Changes (Low-luminance BCVA) [ Time Frame: Screening through Week 84 ]
  • Natural Progression of LSCD as Assessed by Functional Changes (Low-contrast BCVA) [ Time Frame: Screening through Week 84 ]
  • Natural Progression of LSCD as Assessed by Functional Changes (Contrast Sensitivity) [ Time Frame: Screening through Week 84 ]
  • Natural Progression of LSCD as Assessed by Anatomical/Structural Changes [ Time Frame: Screening through Week 84 ]

Central Contacts and Locations

Central contacts

Central Operations Representative

949-354-1299clinicaltrials@clarisbio.com

Locations

Claris Investigative Site

Recruiting

Carmel, Indiana, United States, 46290

Contacts

919-205-0012

Claris Investigative Site

Recruiting

Indianapolis, Indiana, United States, 46260

Contacts

919-205-0012

Claris Investigative Site

Recruiting

Overland Park, Kansas, United States, 66204

Claris Investigative Site

Recruiting

Louisville, Kentucky, United States, 40206

Claris Investigative Site

Recruiting

Minnetonka, Minnesota, United States, 53052

Claris Investigative Site

Recruiting

Portland, Oregon, United States, 97210

Claris Investigative Site

Recruiting

Smyrna, Tennessee, United States, 37167

Claris Investigative Site

Recruiting

San Antonio, Texas, United States, 78212

More Information

Sponsor

Claris Biotherapeutics, Inc.

Last update posted

Aug 6, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Claris Biotherapeutics, Inc. on 2026-08-06.