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

Not Applicable

Not yet recruiting

• Conditions: Dry Eye Disease; Dry Eye; Dry Eye, Evaporative

• Registration Number: NCT06955585
• Lead Sponsor: University Hospital Sestre Milosrdnice

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.

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 Timeline

• Status Verified: 2025-04
• Study First Submitted: 2025-04-24
• Study First Submitted QC: 2025-04-24
• Last Update Submitted: 2025-04-24
• Study Start: 2025-04-25
• Study First Posted: 2025-05-02
• Last Update Posted: 2025-05-02
• Primary Completion: 2025-07
• Study Completion: 2025-09

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Change in Central Precorneal Tear Film Thickness (CPTFT)	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.
Change in Ocular Surface Disease Index (OSDI) Score	Baseline and Day 28	Change in OSDI questionnaire score to evaluate improvement in symptoms of dry eye disease after 28 days of therapy.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

UHC Sestre milosrdnice; 🇭🇷 Zagreb, Grad Zagreb, Croatia