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

NCT06726525 | Completed Phase 4

• 1 other identifier: Prot. 20-22
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Dry Eye

Keywords

dry eye disease; GlicoPro®; Hydroxypropyl-methylcellulose

Outcome Measures

Primary Outcomes (3)

• Ocular Surface Disease Index (OSDI) overall treatment effect

  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

  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

  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

Study Arms (2)

HPMC+GlicoPro Group

EXPERIMENTAL

Device: HPMC+GlicoPro eyedrops

HPMC alone Group

ACTIVE COMPARATOR

Device: Hydroxypropyl-methylcellulose

Interventions

HPMC+GlicoPro eyedrops DEVICE

HPMC+GlicoPro eyedrops, artificial tears for dry eye disease

HPMC+GlicoPro Group

Hydroxypropyl-methylcellulose DEVICE

Hydroxypropyl-methylcellulose eyedrops, artificial tears for dry eye disease

HPMC alone Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Milan: lead
• FB VISION, Ascoli Piceno, Italy: collaborator
• University of Messina: collaborator

Study Sites (1)

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

Messina, 98124, Italy

Location

Related Publications (1)

• 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.

  PMID: 40024993 DERIVED

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Study Officials

• Edoardo Villani, MD

  University of Milan

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor of ophthalmology

Study Record Dates

• First Submitted: December 1, 2024
• First Posted: December 10, 2024
• Study Start: February 3, 2024
• Primary Completion: September 12, 2024
• Study Completion: September 12, 2024
• Last Updated: December 10, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)