Corneal Fluorescein Staining in FDA-Reviewed Dry Eye Registrational Clinical Trials: Evidence of Limited Endpoint Responsiveness
Corneal FL staining demonstrates limited responsiveness as an efficacy endpoint in DED registrational trials. Because 1% LG provides corneal staining strongly associated with 2% FL while preserving discrete punctate detail and allowing standardized, early readouts, it may represent a suitable alternative vital dye for future DED efficacy and safety assessments.
Authors
- Tanya Sheth
- Simon Kaja (ORCID: https://orcid.org/0000-0001-6878-521X)
- Monazzah Akbar Sarwar (ORCID: https://orcid.org/0000-0001-6642-3418)
- Christine Mun
- Zeenal George Dabre
- Natalie Ungaretti
- Christian Kim
- Sandeep Jain
- Kiera Byrne
Institutions
- Loyola University Chicago (US)
- Medical College of Wisconsin (US)
- University of Illinois Chicago (US)
Publication Details
- Journal
- Ophthalmic Research
- Published
- 2026-01-06
- DOI
- https://doi.org/10.1159/000550166
- Primary Topic
- Ocular Surface and Contact Lens
- Type
- article
- Field-Weighted Citation Impact
- 0.00
Funders
- Research to Prevent Blindness
- National Institutes of Health
- National Eye Institute