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Search / Trial NCT06955585

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

Launched by UNIVERSITY HOSPITAL SESTRE MILOSRDNICE · Apr 24, 2025

Trial Information

Current as of June 26, 2025

Not yet recruiting

Keywords

Dry Eye Artificial Tears

ClinConnect Summary

This clinical trial is studying the effectiveness of a new type of artificial tears, called Proluxx eye spray, for treating people with Dry Eye Disease (DED). Dry Eye Disease can make your eyes feel dry, uncomfortable, and irritated. To be eligible for this study, participants need to have a specific score on a questionnaire about their eye health, and they must show signs of dry eyes through some simple tests. For example, one test looks at how quickly tears evaporate from the eye, and another measures tear production.

If you qualify and decide to participate, you will use the Proluxx eye spray four times a day for 28 days. Before starting the treatment, your eye health will be checked using a special imaging tool to measure tear film thickness. After the treatment period, you will return for a follow-up visit where the same eye health assessments will be repeated to see how well the spray worked. This study is currently not yet recruiting participants, and they are looking for individuals aged 65 to 74 who have not used any artificial tears in the two weeks before joining.

Gender

ALL

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

About University Hospital Sestre Milosrdnice

University Hospital Sestre Milosrdnice is a leading healthcare institution located in Zagreb, Croatia, renowned for its commitment to advanced medical research and high-quality patient care. The hospital serves as a pivotal center for clinical trials and innovative therapeutic approaches, leveraging its multidisciplinary expertise to enhance patient outcomes and contribute to the global medical community. With a strong emphasis on ethical standards and regulatory compliance, the institution fosters collaboration among researchers, healthcare professionals, and academic partners, aiming to translate scientific discoveries into effective treatments and improve healthcare practices.

Locations

Zagreb, Grad Zagreb, Croatia

Patients applied

0 patients applied

Trial Officials

Ivanka Petric Vicković, Prof,MD,PHD

Study Director

Eye Department of UHC Sestre milosrdnice Zagreb

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported