Clinical trial NCT06955585: Efficacy of Lipid-containing Artificial Tears in the Treatment of Dry Eye
Official title: Efficacy of Lipid-containing Artificial Tears in the Treatment of Dry Eye
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Dry Eye Disease
Dry Eye
Dry Eye, Evaporative
Keywords: dry eye
artificial tears
Lead sponsor: University Hospital Sestre Milosrdnice
Sponsor class: OTHER
First posted: 2025-05-02
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in Central Precorneal Tear Film Thickness (CPTFT)
timeFrame: Baseline (Day 0) and Day 28
measure: Change in Ocular Surface Disease Index (OSDI) Score
timeFrame: Baseline and Day 28
Secondary outcomes:
measure: Change in Tear Break-Up Time (TBUT)
timeFrame: Baseline and Day 28
measure: Change in Corneal Staining Grade (Oxford Scale)
timeFrame: Baseline and Day 28
Other outcomes:
Locations:
city: Zagreb
country: Croatia
facility: UHC Sestre milosrdnice
state: Grad Zagreb
Study officials:
affiliation: Eye Department of UHC Sestre milosrdnice Zagreb
name: Ivanka Petric Vicković, Prof,MD,PHD
role: STUDY_DIRECTOR
References: