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

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.