Status:
NOT_YET_RECRUITING
Clinical Trial for the Evaluation of Safety and Efficacy of Drop 0.4%
Lead Sponsor:
Avizor SA
Collaborating Sponsors:
Instituto Universitario de Oftalmobiología Aplicada (Institute of Applied Ophthalmobiology) - IOBA
Conditions:
Eye Dryness
Eligibility:
All Genders
18-99 years
Phase:
PHASE3
Brief Summary
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 ov...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
July 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
79 Patients enrolled
Trial Details
Trial ID
NCT06985875
Start Date
July 1 2025
End Date
December 31 2025
Last Update
July 9 2025
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