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

December 9, 2024 updated by: Edoardo Villani, University of Milan

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

44

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Mesina, Italy, 98124
        • Ophthalmology Clinic, Dept. of Biomedical Sciences, University of Messina, Messina, Italy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: HPMC+GlicoPro Group
Device: HPMC+GlicoPro eyedrops
HPMC+GlicoPro eyedrops, artificial tears for dry eye disease
Active Comparator: HPMC alone Group
Device: Hydroxypropyl-methylcellulose
Hydroxypropyl-methylcellulose eyedrops, artificial tears for dry eye disease

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
From enrollment to the end of treatment at 3 months
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)
From enrollment to the end of treatment at 3 months
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).
From enrollment to the end of treatment at 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Milan

Collaborators

University of Messina
FB VISION, Ascoli Piceno, Italy

Investigators

  • Study Director: Edoardo Villani, MD, University of Milan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 3, 2024

Primary Completion (Actual)

September 12, 2024

Study Completion (Actual)

September 12, 2024

Study Registration Dates

First Submitted

December 1, 2024

First Submitted That Met QC Criteria

December 9, 2024

First Posted (Estimated)

December 10, 2024

Study Record Updates

Last Update Posted (Estimated)

December 10, 2024

Last Update Submitted That Met QC Criteria

December 9, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Prot. 20-22

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Dry Eye

Clinical Trials on HPMC+GlicoPro eyedrops

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Israel

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe