Efficacy of Lipid-containing Artificial Tears in the Treatment of Dry Eye

This clinical study involves patients with Dry Eye Disease (DED) who are visiting an ophthalmology outpatient clinic. Eligible participants must have an Ocular Surface Disease Index (OSDI) score ≥14 and \<50, and at least one positive diagnostic test: tear break-up time (TBUT) \<7 seconds, Schirmer I test \<10 mm/5 min, or positive corneal staining based on the Oxford grading scale. At baseline, tear film thickness will be measured using Pentacam imaging. Participants will then receive Proluxx eye spray, applied four times daily for 28 days. After this treatment period, a follow-up examination with all baseline assessments will be repeated.

NCT Number	NCT06955585
Lead Sponsor	University Hospital Sestre Milosrdnice
Conditions	Dry Eye Disease, Dry Eye, Dry Eye, Evaporative
Enrollment	50 participants
Start Date	2025-04-25
Primary Completion	2025-07 (estimated)
Study Completion	2025-09 (estimated)
Updated on ClinicalTrials.gov	2025-05-02