Dry Eye
Conditions
Keywords
dry eye disease, GlicoPro®, Hydroxypropyl-methylcellulose
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
Interventions
DEVICEHPMC+GlicoPro eyedrops
HPMC+GlicoPro eyedrops, artificial tears for dry eye disease
DEVICEHydroxypropyl-methylcellulose
Hydroxypropyl-methylcellulose eyedrops, artificial tears for dry eye disease
Sponsors
FB VISION, Ascoli Piceno, Italy
University of Messina
University of Milan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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) |
| 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) |
| 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). |
Countries
Italy
Outcome results
None listed