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.

Study Overview

• Status: Not yet recruiting
• Conditions: Dry Eye; Dry Eye Disease; Dry Eye, Evaporative
• Intervention / Treatment: Device: Proluxx Artificial Tear Spray

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Danijel Mikulić, MD; Phone Number: 00385989956997; Email: danijel.mikulic@kbcsm.hr

Study Locations

• Croatia
  • Grad Zagreb
    • Zagreb, Grad Zagreb, Croatia, 10000
      • UHC Sestre Milosrdnice

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Proluxx Treatment Group; Group that will use topical artificial tear spray applied to closed eyelids four times daily for 28 days.	Device: Proluxx Artificial Tear Spray; Topical artificial tear spray applied to closed eyelids four times daily for 28 days.; Other Names: Proluxx Duo sprej za oko

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Central Precorneal Tear Film Thickness (CPTFT)	Change in central precorneal tear film thickness measured using Pentacam imaging between baseline and after 28 days of treatment with Proluxx artificial tear spray.	Baseline (Day 0) and Day 28
Change in Ocular Surface Disease Index (OSDI) Score	Change in OSDI questionnaire score to evaluate improvement in symptoms of dry eye disease after 28 days of therapy.	Baseline and Day 28

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Tear Break-Up Time (TBUT)	Measurement of tear film stability by TBUT test, comparing values at baseline and after 28 days of treatment.	Baseline and Day 28
Change in Corneal Staining Grade (Oxford Scale)	Assessment of ocular surface damage using Oxford grading of corneal staining at baseline and after treatment.	Baseline and Day 28

Collaborators and Investigators

• Sponsor: University Hospital Sestre Milosrdnice
• Investigators: Study Director: Ivanka Petric Vicković, Prof,MD,PHD, Eye Department of UHC Sestre milosrdnice Zagreb

Study record dates

Study Major Dates

• Study Start (Estimated): April 25, 2025
• Primary Completion (Estimated): July 1, 2025
• Study Completion (Estimated): September 1, 2025

Study Registration Dates

• First Submitted: April 24, 2025
• First Submitted That Met QC Criteria: April 24, 2025
• First Posted (Actual): May 2, 2025

Study Record Updates

• Last Update Posted (Actual): May 2, 2025
• Last Update Submitted That Met QC Criteria: April 24, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: dry eye; artificial tears
• Additional Relevant MeSH Terms: Corneal Diseases; Lacrimal Apparatus Diseases; Keratoconjunctivitis; Conjunctivitis; Conjunctival Diseases; Keratitis; Eye Diseases; Dry Eye Syndromes; Keratoconjunctivitis Sicca; Ophthalmic Solutions; Pharmaceutical Solutions; Lubricant Eye Drops
• Other Study ID Numbers: DED-2025

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No