Clinical Efficacy of Amniotic Membrane Extract Eye Drops in Dry Eye Treatment

Dry Eyes Chronic Clinical Trial

Official title: Clinical Efficacy of Amniotic Membrane Extract Eye Drops in Dry Eye Treatment

Status Withdrawn

Clinical Trial Summary

This prospective longitudinal study aims at evaluating the clinical efficacy of human amniotic fluid extract eye drops in the treatment of dry eye disease. 25 patients who are diagnosed with dry eye disease as defined by our criteria will be recruited from the cornea and dry eye clinic at Stein Eye Institute, UCLA. Pre-treatment baseline evaluations, 6 weeks, 12 weeks, and 24 weeks post treatment assessments will be performed by the principle investigator and co-investigator. All tests are considered non-invasive and are within the standard of practice in the evaluation for dry eye disease: (1) Ocular Surface Disease Index Questionnaire (OSDI); (2) Non-contact Tear Break-up Time (NITBUT); (3) Shirmer's test without anesthesia; (4) Ocular Surface Staining with Fluorescein and Lissamine green. Result of each test will be compared and analyzed to provide evidence of treatment efficacy. Treatment will be initiated for 12 weeks at a self-administered dose of one drop in both eyes two times per day. A follow-up of the study will be observed at the 24th week from the first day of treatment. All side effects and adverse events will be carefully observed and documented. Patients will be able to discontinue using the medication if they are not tolerating any side effects.

Clinical Trial Description

n/a

Related Conditions & MeSH terms

• Dry Eye Syndromes
• Dry Eyes Chronic
• Keratoconjunctivitis Sicca

• NCT number: NCT05169931
• Study type: Interventional
• Source: University of California, Los Angeles
• Status: Withdrawn
• Phase: Early Phase 1
• Start date: January 2022
• Completion date: May 2022