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

NCT06955585 | Not Yet Recruiting

• 1 other identifier: DED-2025
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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

Dry Eye Disease; Dry Eye; Dry Eye, Evaporative

Keywords

dry eye; artificial tears

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Change in Tear Break-Up Time (TBUT)

  Baseline and Day 28

• Change in Corneal Staining Grade (Oxford Scale)

  Baseline and Day 28

Study Arms (1)

Proluxx Treatment Group

EXPERIMENTAL

Group that will use topical artificial tear spray applied to closed eyelids four times daily for 28 days.

Device: Proluxx Artificial Tear Spray

Interventions

Proluxx Artificial Tear Spray DEVICE

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

Also known as: Proluxx Duo sprej za oko

Proluxx Treatment Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital Sestre Milosrdnice: lead

Study Sites (1)

UHC Sestre milosrdnice

Zagreb, City of Zagreb, 10000, Croatia

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Study Officials

• Ivanka Petric Vicković, Prof,MD,PHD

  Eye Department of UHC Sestre milosrdnice Zagreb

  STUDY DIRECTOR

Central Study Contacts

Danijel Mikulić, MD

CONTACT

00385989956997; danijel.mikulic@kbcsm.hr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: April 24, 2025
• First Posted: May 2, 2025
• Study Start: April 25, 2025
• Primary Completion: July 1, 2025
• Study Completion: September 1, 2025
• Last Updated: May 2, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

CR (1)