Clinical trial NCT06985875: Clinical Trial for the Evaluation of Safety and Efficacy of Drop 0.4%
Official title: Clinical Trial for the Evaluation of the Safety and Efficacy of a Moisturizing Solution With Hyaluronic Acid Drop 0.4%
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: Eye Dryness
Keywords: contact lens, dry eye
Lead sponsor: Avizor SA
Sponsor class: INDUSTRY
Collaborators: name: Instituto Universitario de Oftalmobiología Aplicada (Institute of Applied Ophthalmobiology) - IOBA
First posted: 2025-05-22
Enrollment: 79
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Both Arms receive both Investigational product and comparator in a crossover design. Randomization determines the order of administration. A washout period between both treatments is performed.
Primary purpose: TREATMENT

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 over one month of use.


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.

Primary outcomes:
measure: Changes in eye dryness symptoms
timeFrame: 1 month
measure: Changes in eye dryness symptoms
timeFrame: 1 month
measure: Changes in best corrected visual acuity (safety outcome)
timeFrame: 1 month
measure: Ocular and peri orbital adverse events
timeFrame: 1 month
measure: Serious adverse events
timeFrame: 1 month
Secondary outcomes:
measure: Stability of the tear film
timeFrame: 1 month
measure: Ocular surface response to treatment - Oxford Scale (0 (Better) to 5 (Worse))
timeFrame: 1 month
measure: Tear evaporation
timeFrame: 1 month
measure: Number of instillations per product
timeFrame: 1 month
measure: User satisfaction with the product
timeFrame: 1 month
Other outcomes:
Locations:
Study officials:
References: