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Completed

NCT Number: NCT06726525

Hydroxypropyl-methylcellulose and GlicoPro® Eyedrops in the Treatment of Dry Eye Disease: Clinical Study

The goal of this clinical trial is to learn if Hydroxypropyl-methylcellulose and GlicoPro® eyedrops work to treat mild-to-moderate dry eye disease in adult patients. The main questions it aims to answer are:

Do Hydroxypropyl-methylcellulose and GlicoPro® eyedrops reduce patients' symptoms? Do Hydroxypropyl-methylcellulose and GlicoPro® eyedrops increase patients' tear film stability? Researchers will compare Hydroxypropyl-methylcellulose and GlicoPro® eyedrops to Hydroxypropyl-methylcellulose without GlicoPro® eyedrops to see if Hydroxypropyl-methylcellulose and GlicoPro® formulation works better to treat dry eye..

Participants will

* Take Hydroxypropyl-methylcellulose and GlicoPro® eyedrops or Hydroxypropyl-methylcellulose eyedrops every day for 3 months * Visit the clinic 3 times in 3 months for checkups and tests

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Key information

Conditions

Dry Eye Dry Eye Syndromes Eye Diseases Lacrimal Apparatus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Ophthalmology Clinic, Dept. of Biomedical Sciences, University of Messina, Messina, Italy

Messina, 98124, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age >18 years
  • Ocular Surface Disease Index (OSDI) >12 AND <65
  • Fluorescein breakup time (FBUT) <10 seconds OR (Oxford staining Score >1 AND <4).

Exclusion criteria

  • Systemic or ocular diseases with known effect on tear film and ocular surface
  • Systemic or ocular medications with known effect on tear film and ocular surface
  • Contact lens wearing,
  • Ocular surgery in the 12 months before enrollment
  • Known allergy or poor tolerance to any ingredient of the study products
  • Presumed poor compliance to study procedures.

Treatment and study plan

HPMC+GlicoPro eyedrops

Device

HPMC+GlicoPro eyedrops, artificial tears for dry eye disease

Hydroxypropyl-methylcellulose

Device

Hydroxypropyl-methylcellulose eyedrops, artificial tears for dry eye disease

Primary outcomes

  1. Ocular Surface Disease Index (OSDI) overall treatment effect

    Time frame: From enrollment to the end of treatment at 3 months

    OSDI is a standardized questionnaire for dry eye symptoms (Schiffman RM, et al. Reliability and validity of the Ocular Surface Disease Index. Arch Ophthalmol. 2000 May;118(5):615-21. ).

    OSDI overall treatment effect (Month 1 and Month 3)

  2. Symptom Assessment iN Dry Eye (SANDE) overall treatment effect

    Time frame: From enrollment to the end of treatment at 3 months

    SANDE is a validated short global dry eye symptom index (Schaumberg DA, et al. Development and validation of a short global dry eye symptom index. Ocul Surf. 2007 Jan;5(1):50-7) SANDE overall treatment effect (Month 1 and Month 3)

  3. Fluorescein Break-up time (FBUT) overall treatment effect

    Time frame: From enrollment to the end of treatment at 3 months

    FBUT is a widely used method to assess tear film stability (Wolffsohn JS, et al. TFOS DEWS II Diagnostic Methodology report. Ocul Surf. 2017 Jul;15(3):539-574. ) FBUT overall treatment effect (Month 1 and Month 3).

Sponsors and collaborators

Lead sponsor

University of Milan

Other

Collaborators

  • FB VISION, Ascoli Piceno, Italy
  • University of Messina

Registry information

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Dec 10, 2024
Registry last updated
Dec 10, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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