Clinical Trial for the Evaluation of Safety and Efficacy of Drop 0.4%
NCT ID: NCT06985875
Last Updated: 2025-07-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE3
79 participants
INTERVENTIONAL
2025-07-31
2025-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
TRIPLE
Study Groups
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Contact lens users with eye dryness
Contact lens users that have eye dryness symptoms. Both treatments will be administered, as it is a crossover study.
Multidose mosturizing solution DROP 0.4%
Ophthalmic mosturizing solution to be administered 1-4 times per day in both eyes
Multidose mosturizing solution Avizor Eye Drops 0.2% Preserved
Ophthalmic mosturizing solution to be administered 1-4 times per day in both eyes
Non contact lens user with eye dryness
Non contact lens patients with eye dryness symptoms. Both treatments will be administered, as it is a crossover study.
Multidose mosturizing solution DROP 0.4%
Ophthalmic mosturizing solution to be administered 1-4 times per day in both eyes
Multidose mosturizing solution Avizor Eye Drops 0.2% Preserved
Ophthalmic mosturizing solution to be administered 1-4 times per day in both eyes
Interventions
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Multidose mosturizing solution DROP 0.4%
Ophthalmic mosturizing solution to be administered 1-4 times per day in both eyes
Multidose mosturizing solution Avizor Eye Drops 0.2% Preserved
Ophthalmic mosturizing solution to be administered 1-4 times per day in both eyes
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
99 Years
ALL
No
Sponsors
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Instituto Universitario de Oftalmobiología Aplicada (Institute of Applied Ophthalmobiology) - IOBA
OTHER
Avizor SA
INDUSTRY
Responsible Party
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Central Contacts
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Other Identifiers
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IOBA-Avizor 001-2024
Identifier Type: -
Identifier Source: org_study_id
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