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

Overview

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.

Interventions

• Device Proluxx Artificial Tear Spray
  Topical artificial tear spray applied to closed eyelids four times daily for 28 days.

Primary outcome measures

• Change in Central Precorneal Tear Film Thickness (CPTFT) [Time frame: Baseline (Day 0) and Day 28]
• Change in Ocular Surface Disease Index (OSDI) Score [Time frame: Baseline and Day 28]

Secondary outcome measures (2)

• Change in Tear Break-Up Time (TBUT) [Time frame: Baseline and Day 28]
• Change in Corneal Staining Grade (Oxford Scale) [Time frame: Baseline and Day 28]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

Croatia · 1 center

• UHC Sestre milosrdnice — Zagreb

Identifiers

NCT: NCT06955585 · DED-2025

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗