NCT06726525|CompletedPhase 4
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Sponsor study identifier
interventional
44
1 country
1
Study Start
February 3, 2024
Actual (reported)Primary Completion
September 12, 2024
Actual (reported)Study Completion
September 12, 2024
Actual (reported)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
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 12, 2024
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 3, 2024
Actual (reported)September 12, 2024
Actual (reported)September 12, 2024
Actual (reported)December 1, 2024
Actual (reported)December 10, 2024
Actual (reported)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
HPMC+GlicoPro eyedrops, artificial tears for dry eye disease
Hydroxypropyl-methylcellulose eyedrops, artificial tears for dry eye disease
Ophthalmology Clinic, Dept. of Biomedical Sciences, University of Messina, Messina, Italy
Messina, 98124, Italy
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.
Edoardo Villani, MD
University of Milan
44 participants (actual enrollment reported by the registry).
First Submitted
December 1, 2024
First Posted
December 10, 2024
Study Start
February 3, 2024
Actual (reported)Performance of Systane PRO Versus Refresh Optive Mega-3
Contact the study team to confirm eligibility.
Primary Completion
September 12, 2024
Actual (reported)Study Completion
September 12, 2024
Actual (reported)Last Updated
December 10, 2024
Record last verified: 2024-12
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