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NCT Number: NCT06955585

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.

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Key information

Conditions

Dry Eye Disease Dry Eye Dry Eye Syndromes Dry Eye, Evaporative Eye Diseases Lacrimal Apparatus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UHC Sestre milosrdnice

Zagreb, City of Zagreb, 10000, Croatia

About this study

This clinical trial aims to evaluate the effects of Proluxx artificial tear spray in patients diagnosed with Dry Eye Disease (DED). Participants are recruited from an ophthalmology outpatient clinic and must have had symptoms of DED for at least 3 months. Inclusion criteria include an 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

include the use of systemic or topical corticosteroids, active ocular infection, or ocular surgery within the last 3 months.

The goal of the study is to classify patients based on DED subtype: hyposecretory, evaporative, or mixed. The study will analyze clinical parameters at baseline, including OSDI score, TBUT, Schirmer test, Oxford staining, CPTFT (central precorneal tear film thickness) measured by Pentacam, BCVA (best corrected visual acuity), intraocular pressure (IOP), and risk factors. Participants will use Proluxx artificial tear spray four times daily for 28 days. After the treatment period, all baseline assessments will be repeated.

The study will compare clinical findings from Day 0 and Day 28 to assess changes in ocular surface health and tear film quality following therapy.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Proluxx Artificial Tear Spray

Device

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

Other names: Proluxx Duo sprej za oko

Primary outcomes

  1. Change in Central Precorneal Tear Film Thickness (CPTFT)

    Time frame: Baseline (Day 0) and Day 28

    Change in central precorneal tear film thickness measured using Pentacam imaging between baseline and after 28 days of treatment with Proluxx artificial tear spray.

  2. Change in Ocular Surface Disease Index (OSDI) Score

    Time frame: Baseline and Day 28

    Change in OSDI questionnaire score to evaluate improvement in symptoms of dry eye disease after 28 days of therapy.

Secondary outcomes

  1. Change in Tear Break-Up Time (TBUT)

    Time frame: Baseline and Day 28

    Measurement of tear film stability by TBUT test, comparing values at baseline and after 28 days of treatment.

  2. Change in Corneal Staining Grade (Oxford Scale)

    Time frame: Baseline and Day 28

    Assessment of ocular surface damage using Oxford grading of corneal staining at baseline and after treatment.

Study contacts

Contact information is provided by the study sponsor or research team.

Danijel Mikulić, MD

CONTACT

[email protected]

00385989956997

Sponsors and collaborators

Lead sponsor

University Hospital Sestre Milosrdnice

Other

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
May 2, 2025
Registry last updated
May 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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