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Not yet recruiting NCT06985875

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

Phase III Interventional Eye Dryness

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Multidose mosturizing solution DROP 0.4%, Multidose mosturizing solution Avizor Eye Drops 0.2% Preserved.
Who it may be relevant to
Registry conditions: Eye Dryness. Basic parameters: 18 years — 99 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Device Multidose mosturizing solution DROP 0.4%
    Ophthalmic mosturizing solution to be administered 1-4 times per day in both eyes
  • Device Multidose mosturizing solution Avizor Eye Drops 0.2% Preserved
    Ophthalmic mosturizing solution to be administered 1-4 times per day in both eyes

Primary outcome measures

  • Changes in eye dryness symptoms [Time frame: 1 month]
  • Changes in eye dryness symptoms [Time frame: 1 month]
  • Changes in best corrected visual acuity (safety outcome) [Time frame: 1 month]
  • Ocular and peri orbital adverse events [Time frame: 1 month]
  • Serious adverse events [Time frame: 1 month]
Secondary outcome measures (5)
  • Stability of the tear film [Time frame: 1 month]
  • Ocular surface response to treatment - Oxford Scale (0 (Better) to 5 (Worse)) [Time frame: 1 month]
  • Tear evaporation [Time frame: 1 month]
  • Number of instillations per product [Time frame: 1 month]
  • User satisfaction with the product [Time frame: 1 month]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Crossover
Masking
Triple blind
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06985875 · IOBA-Avizor 001-2024

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗