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

NCT06955585 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2025-05-02

No results posted yet for this study

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.

Conditions

Interventions

DEVICE

Proluxx Artificial Tear Spray

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

Sponsors & Collaborators

  • University Hospital Sestre Milosrdnice

    lead OTHER

Principal Investigators

  • Ivanka Petric Vicković, Prof,MD,PHD · Eye Department of UHC Sestre milosrdnice Zagreb

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-04-25
Primary Completion
2025-07-31
Completion
2025-09-30

Countries

  • Croatia

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06955585 on ClinicalTrials.gov