Health TrialsbyHealthPanel

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

ConditionsDry Eye DiseaseDry EyeDry Eye, Evaporative
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital Sestre Milosrdnice

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • Proluxx Artificial Tear Spray

    Device

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

Treatment groups

50 Participants
are divided into 1 treatment group
Group A: Proluxx Treatment GroupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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
2

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

Secondary outcomes

1

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
2

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Hospital Sestre Milosrdnice

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: