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NOT YET RECRUITING
NCT06955585
NA

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

Sponsor: University Hospital Sestre Milosrdnice

View on ClinicalTrials.gov

Summary

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.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

50

Start Date

2025-04-25

Completion Date

2025-09

Last Updated

2025-05-02

Healthy Volunteers

No

Interventions

DEVICE

Proluxx Artificial Tear Spray

Topical artificial tear spray applied to closed eyelids four times daily for 28 days.

Locations (1)

UHC Sestre milosrdnice

Zagreb, City of Zagreb, Croatia