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

Last updated: December 9, 2024
Sponsor: University of Milan
Overall Status: Completed

Phase

4

Condition

Dry Eye Disease

Eyelid Inflammation

Sjogren's Syndrome

Treatment

HPMC+GlicoPro eyedrops

Hydroxypropyl-methylcellulose

Clinical Study ID

NCT06726525
Prot. 20-22
  • Ages > 18
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

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

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.

Study Design

Total Participants: 44
Treatment Group(s): 2
Primary Treatment: HPMC+GlicoPro eyedrops
Phase: 4
Study Start date:
February 03, 2024
Estimated Completion Date:
September 12, 2024

Connect with a study center

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

    Mesina, 98124
    Italy

    Site Not Available

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