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

NCT06985875 | Not Yet Recruiting Phase 3

• 1 other identifier: IOBA-Avizor 001-2024
• Study Type: interventional
• Target: 79
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Eye Dryness

Keywords

contact lens, dry eye

Outcome Measures

Primary Outcomes (5)

• Changes in eye dryness symptoms

  Changes in ocular symptoms (measured with Contact lens dry eye questionnaire and/or change in the frequency and intensity of dry eye symptoms (measured with a Visual analogue scale from 0 to 10). For contact lens users

  1 month

• Changes in eye dryness symptoms

  Changes in ocular symptoms (measured with Ocular surface disease index and/or change in the frequency and intensity of dry eye symptoms (measured with a Visual analogue scale from 0 to 10). For non contact lens users

  1 month

• Changes in best corrected visual acuity (safety outcome)

  Best corrected visual acuity tested with ETDRS (early treatment for diabetes retinopathy study).

  1 month

• Ocular and peri orbital adverse events

  All local adverse events reported

  1 month

• Serious adverse events

  All local and systemic serious adverse events

  1 month

Secondary Outcomes (5)

• Stability of the tear film

  1 month

• Ocular surface response to treatment - Oxford Scale (0 (Better) to 5 (Worse))

  1 month

• Tear evaporation

  1 month

• Number of instillations per product

  1 month

• User satisfaction with the product

  1 month

Study Arms (2)

Contact lens users with eye dryness

OTHER

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

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

Non contact lens user with eye dryness

OTHER

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

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

Interventions

Multidose mosturizing solution DROP 0.4% DEVICE

Ophthalmic mosturizing solution to be administered 1-4 times per day in both eyes

Contact lens users with eye dryness; Non contact lens user with eye dryness

Multidose mosturizing solution Avizor Eye Drops 0.2% Preserved DEVICE

Ophthalmic mosturizing solution to be administered 1-4 times per day in both eyes

Contact lens users with eye dryness; Non contact lens user with eye dryness

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Avizor SA: lead
• Instituto Universitario de Oftalmobiología Aplicada (Institute of Applied Ophthalmobiology) - IOBA: collaborator

MeSH Terms

Conditions

Xerophthalmia; Dry Eye Syndromes

Interventions

Preservation, Biological

Condition Hierarchy (Ancestors)

Conjunctival Diseases; Eye Diseases; Lacrimal Apparatus Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Investigative Techniques

Central Study Contacts

Francisco Blazquez, MD, MsC

CONTACT

(+34) 983184734; fblazqueza@fundacion.uva.es

Maria Jesus Gonzalez Garcia, OD, PhD

CONTACT

(+34) 983184734; mariajesus.gonzalez.garcia@uva.es

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Product and comparator have the same external and physical characteristics and the label is the same for both products except for expiry date
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: May 15, 2025
• First Posted: May 22, 2025
• Study Start: July 1, 2025
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: July 9, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share