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

U

University of Milan

Status and phase

Completed
Phase 4

Conditions

Dry Eye

Treatments

Device: Hydroxypropyl-methylcellulose
Device: HPMC+GlicoPro eyedrops

Study type

Interventional

Funder types

Other

Identifiers

NCT06726525
Prot. 20-22

Details and patient eligibility

About

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

Enrollment

44 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

44 participants in 2 patient groups

HPMC+GlicoPro Group
Experimental group
Treatment:
Device: HPMC+GlicoPro eyedrops
HPMC alone Group
Active Comparator group
Treatment:
Device: Hydroxypropyl-methylcellulose

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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