Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| FB VISION, Ascoli Piceno, Italy | UNKNOWN |
| University of Messina | OTHER |
Not provided
Not provided
Not provided
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
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HPMC+GlicoPro Group | Experimental |
| |
| HPMC alone Group | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HPMC+GlicoPro eyedrops | Device | HPMC+GlicoPro eyedrops, artificial tears for dry eye disease |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Edoardo Villani, MD | University of Milan | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ophthalmology Clinic, Dept. of Biomedical Sciences, University of Messina, Messina, Italy | Messina | 98124 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40024993 | Derived | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D015352 | Dry Eye Syndromes |
| ID | Term |
|---|---|
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Hydroxypropyl-methylcellulose | Device | Hydroxypropyl-methylcellulose eyedrops, artificial tears for dry eye disease |
|