Not Yet RecruitingNot Applicable

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

Croatia50 participantsStarted 2025-04-25

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Ocular Surface Disease Index (OSDI) score between 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 scheme. In addition, participants must not have used artificial tears for at least two weeks prior to enrollment, even if they were previously on such therapy Exclusion Criteria: * use of systemic or topical corticosteroids, active ocular infection, or ocular surgery within the last 3 months

What they're measuring

Change in Central Precorneal Tear Film Thickness (CPTFT)

Timeframe: Baseline (Day 0) and Day 28

Change in Ocular Surface Disease Index (OSDI) Score

Timeframe: Baseline and Day 28

Trial details

NCT IDNCT06955585

SponsorUniversity Hospital Sestre Milosrdnice

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-07

Contact for this trial

Danijel Mikulić, MD

00385989956997 danijel.mikulic@kbcsm.hr