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

NCT ID: NCT06726525

Last Updated: 2024-12-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-02-03

Study Completion Date

2024-09-12

Brief Summary

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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

Detailed Description

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Conditions

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Dry Eye

Keywords

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dry eye disease GlicoPro® Hydroxypropyl-methylcellulose

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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HPMC+GlicoPro Group

Group Type EXPERIMENTAL

HPMC+GlicoPro eyedrops

Intervention Type DEVICE

HPMC+GlicoPro eyedrops, artificial tears for dry eye disease

HPMC alone Group

Group Type ACTIVE_COMPARATOR

Hydroxypropyl-methylcellulose

Intervention Type DEVICE

Hydroxypropyl-methylcellulose eyedrops, artificial tears for dry eye disease

Interventions

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HPMC+GlicoPro eyedrops

HPMC+GlicoPro eyedrops, artificial tears for dry eye disease

Intervention Type DEVICE

Hydroxypropyl-methylcellulose

Hydroxypropyl-methylcellulose eyedrops, artificial tears for dry eye disease

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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FB VISION, Ascoli Piceno, Italy

UNKNOWN

Sponsor Role collaborator

University of Messina

OTHER

Sponsor Role collaborator

University of Milan

OTHER

Sponsor Role lead

Responsible Party

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Edoardo Villani

Associate professor of ophthalmology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Edoardo Villani, MD

Role: STUDY_DIRECTOR

University of Milan

Locations

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

Messina, , Italy

Site Status

Countries

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Italy

References

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Villani E, Campagna G, Gentili V, Postorino EI, Genovese P, Palino P, Maini G, Carbucicchio A, Ferioli E, Nucci P, Rizzo R, Aragona P. Hydroxypropyl-Methylcellulose and GlicoPro(R) Eyedrops in the Treatment of Dry Eye Disease: In Vitro and Clinical Study. Ophthalmol Ther. 2025 Apr;14(4):787-803. doi: 10.1007/s40123-025-01101-6. Epub 2025 Mar 1.

Reference Type DERIVED
PMID: 40024993 (View on PubMed)

Other Identifiers

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Prot. 20-22

Identifier Type: -

Identifier Source: org_study_id