An interventional study of Proluxx Artificial Tear Spray in Dry Eye Disease, Dry Eye and Dry Eye, Evaporative, sponsored by University Hospital Sestre Milosrdnice. Not yet recruiting at 1 site in Croatia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-05-02.
Sponsored by University Hospital Sestre Milosrdnice · Not applicable, Interventional, and Treatment
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.
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.
1,292 studies on the registry are indexed under Dry Eye Syndromes; 191 are open to participants now.
This study's planned enrollment of 50 is below the median of 60 across 1,077 interventional studies indexed under Dry Eye Syndromes.
Browse Dry Eye Syndromes studies →University Hospital Sestre Milosrdnice is the lead sponsor of 27 studies on the registry; 8 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Also known as: Proluxx Duo sprej za oko
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.
Time frame: 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.
Time frame: Baseline and Day 28
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.
Time frame: 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.
Time frame: Baseline and Day 28
Plan to share: No
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.
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University Hospital Sestre Milosrdnice