Clinical Trial for the Evaluation of Safety and Efficacy of Drop 0.4%

Clinical Trial for the Evaluation of the Safety and Efficacy of a Moisturizing Solution With Hyaluronic Acid Drop 0.4%

The aim of the trial is to compare the safety and efficacy of the moisturizing solution DROP 0.4% with the moisturizing solution AVIZOR EYE DROPS 0.2% PRESERVED in relieving the symptoms of dry eye over one month of use.

INCLUSION CRITERIA:

• Male or female, aged 18 years or older, capable of freely providing informed consent for participation in the study.
• Signed informed consent form prior to any study-related tests.
• Signed data protection form prior to any study-related tests.

Additionally, for Group 1 (Non contact lens users)

• Ocular surface disease index (OSDI) ≥ 13
• No use of contact lenses in the past month and not planning to use them during the study period.

Additionally, for Group 2 (contact lens users)

• Contact lens dry eye questionnaire (CLDEQ-8) ≥ 12
• Contact lens (CL) use with a habitual minimum use of 4 days per week and 4 hours per day in the past month.

EXCLUSION CRITERIA:

• Any active ocular surface disease except for dry eye disease.

• Severe dry eye, defined as meeting at least one of the following criteria in at least one eye:

  • Corneal fluorescein staining ≥ 4 on the Oxford scale (0-5).
  • Conjunctival lissamine green staining ≥ 4 on the Oxford scale (0-5).
  • Schirmer test value ≤ 2 mm.
  • Tear stability (BUT) of 0 seconds.

• History of ocular surgery in the last 3 months or refractive corneal surgery in the last 6 months.

• History of herpetic keratitis or uveitis.

• History of severe ocular infections or inflammation in the 6 months prior to the study.

• History of allergies affecting the ocular surface during the study period.

• Patients who have started or are expected to modify the use of the following topical medications during the study (except for artificial tears/moisturizing and lubricating solutions):

  • Calcineurin inhibitors (cyclosporine, tacrolimus, etc.) in the 12 weeks prior to the study.
  • Corticosteroids or non steroid anti-inflammatory drugs (NSAID) in the 4 weeks prior to the study.
  • Blood-derived treatments (autologous serum, enriched plasma, etc.), insulin, or amniotic preparations in the week prior to the study.

• Use of systemic medication with potential effects on the tear film that has been started or modified in the last month or is expected to change during the study.

• Known sensitivity or intolerance to any of the products used in the study.

• Subjects with clinically relevant or uncontrolled systemic diseases in the last 3 months that may interfere with study assessments or outcomes.

• Pregnancy or breastfeeding. Lack of effective contraceptive methods in women of childbearing potential.

• Participation in a clinical trial within the last 30 days.