Clinical Trial for the Evaluation of Safety and Efficacy of Drop 0.4% (DROP04)

Avizor SA

Status and phase: Not yet enrolling; Phase 3

Conditions: Eye Dryness

Treatments: Device: Multidose mosturizing solution DROP 0.4%; Device: Multidose mosturizing solution Avizor Eye Drops 0.2% Preserved

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06985875

IOBA-Avizor 001-2024

Details and patient eligibility

About

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.

Enrollment: 79 estimated patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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79 participants in 2 patient groups

Contact lens users with eye dryness

Other group

Description:

Contact lens users that have eye dryness symptoms. Both treatments will be administered, as it is a crossover study.

Treatment:

Device: Multidose mosturizing solution Avizor Eye Drops 0.2% Preserved

Device: Multidose mosturizing solution DROP 0.4%

Non contact lens user with eye dryness

Other group

Description:

Non contact lens patients with eye dryness symptoms. Both treatments will be administered, as it is a crossover study.

Treatment:

Device: Multidose mosturizing solution Avizor Eye Drops 0.2% Preserved

Device: Multidose mosturizing solution DROP 0.4%