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

Phase 4

Completed

• Conditions: Dry Eye

• Registration Number: NCT06726525
• Lead Sponsor: University of Milan

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

Detailed Description

Not available

Study Timeline

• Study Start: 2024-02-03
• Primary Completion: 2024-09-12
• Study Completion: 2024-09-12
• Status Verified: 2024-12
• Study First Submitted: 2024-12-01
• Study First Submitted QC: 2024-12-09
• Last Update Submitted: 2024-12-09
• Study First Posted: 2024-12-10
• Last Update Posted: 2024-12-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 44

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Symptom Assessment iN Dry Eye (SANDE) overall treatment effect	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)
Ocular Surface Disease Index (OSDI) overall treatment effect	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)
Fluorescein Break-up time (FBUT) overall treatment effect	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).

Trial Locations

Locations (1)

Ophthalmology Clinic, Dept. of Biomedical Sciences, University of Messina, Messina, Italy; 🇮🇹 Mesina, Italy