Eye DrynessPhase 3DROP04NCT06985875
Clinical Trial for the Evaluation of Safety and Efficacy of Drop 0.4%
A Phase 3 study testing Multidose mosturizing solution DROP 0.4% and Multidose mosturizing solution Avizor Eye Drops 0.2% Preserved in people with Eye Dryness, run by Avizor SA.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Eye Dryness
- What is being tested?
- Multidose mosturizing solution DROP 0.4% and Multidose mosturizing solution Avizor Eye Drops 0.2% Preserved
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 79 participants
- Where
- No sites listed yet
- Study dates
- Jul 2025to 31 Dec 2025
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Show all 9Show fewer
- 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.
Who cannot join
- 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.
Show all 19Show fewer
- 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 locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Clinical Trial for the Evaluation of the Safety and Efficacy of a Moisturizing Solution With Hyaluronic Acid Drop 0.4%
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
- Being tested
- Multidose mosturizing solution DROP 0.4%, Multidose mosturizing solution Avizor Eye Drops 0.2% Preserved
- Keywords
- contact lens, dry eye
- Medical subject headings
- Xerophthalmia, Dry Eye Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multidose mosturizing solution DROP 0.4%Device
Ophthalmic mosturizing solution to be administered 1-4 times per day in both eyes
Multidose mosturizing solution Avizor Eye Drops 0.2% PreservedDevice
Ophthalmic mosturizing solution to be administered 1-4 times per day in both eyes
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Multidose mosturizing solution DROP 0.4%; Device: Multidose mosturizing solution Avizor Eye Drops 0.2% Preserved |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 1 month
Changes in best corrected visual acuity (safety outcome)
Best corrected visual acuity tested with ETDRS (early treatment for diabetes retinopathy study).
Measured: 1 month
Ocular and peri orbital adverse events
All local adverse events reported
Measured: 1 month
Serious adverse events
All local and systemic serious adverse events
Measured: 1 month
Secondary outcomes (5)
Stability of the tear film
Measurement of tear film stability by Non-Invasive Break-Up Time (NIBUT).
Measured: 1 month
Ocular surface response to treatment - Oxford Scale (0 (Better) to 5 (Worse))
Corneal staining with fluorescein, green lissamine and conjunctival hyperemia
Measured: 1 month
Tear evaporation
Assessed by evaporimetry
Measured: 1 month
Number of instillations per product
Comparison between the number of intimations of both products
Measured: 1 month
User satisfaction with the product
Numerical scale from 1 to 10
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2025
- Study startJul 2025 (estimated)
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Eye DrynessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- 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.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 79 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Avizor SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Instituto Universitario de Oftalmobiología Aplicada (Institute of Applied Ophthalmobiology) - IOBA
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06985875
- Sponsor's protocol ID
- IOBA-Avizor 001-2024
- Acronym
- DROP04
- Status last verified
- Jul 2025
- First submitted
- 15 May 2025
- Last updated
- 9 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial for the Evaluation of the Safety and Efficacy of a Moisturizing Solution With Hyaluronic Acid Drop 0.4%
- ClinicalTrials.gov ID
- NCT06985875
- Acronym / sponsor ID
- DROP04 / IOBA-Avizor 001-2024
- Conditions
- Eye Dryness
- Keywords
- contact lens, dry eye
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 79 participants (estimated)
- Lead sponsor
- Avizor SAIndustry (pharma, biotech, devices)
- Collaborators
- Instituto Universitario de Oftalmobiología Aplicada (Institute of Applied Ophthalmobiology) - IOBA
- Study start
- Jul 2025 (estimated)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 22 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Contact lens users with eye dryness | Other | Device: Multidose mosturizing solution DROP 0.4%, Device: Multidose mosturizing solution Avizor Eye Drops 0.2% PreservedContact lens users that have eye dryness symptoms. Both treatments will be administered, as it is a crossover study. |
| Non contact lens user with eye dryness | Other | Device: Multidose mosturizing solution DROP 0.4%, Device: Multidose mosturizing solution Avizor Eye Drops 0.2% PreservedNon contact lens patients with eye dryness symptoms. Both treatments will be administered, as it is a crossover study. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (19 listed)
- 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:
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multidose mosturizing solution DROP 0.4%Ophthalmic mosturizing solution to be administered 1-4 times per day in both eyes | Device | Contact lens users with eye dryness, Non contact lens user with eye dryness |
| Multidose mosturizing solution Avizor Eye Drops 0.2% PreservedOphthalmic mosturizing solution to be administered 1-4 times per day in both eyes | Device | Contact lens users with eye dryness, Non contact lens user with eye dryness |
Primary outcome
Changes in eye dryness symptoms
Time frame: 1 month
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
Changes in eye dryness symptoms
Time frame: 1 month
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
Changes in best corrected visual acuity (safety outcome)
Time frame: 1 month
Best corrected visual acuity tested with ETDRS (early treatment for diabetes retinopathy study).
Ocular and peri orbital adverse events
Time frame: 1 month
All local adverse events reported
Serious adverse events
Time frame: 1 month
All local and systemic serious adverse events
5 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2025.
- Individual participant dataSharing planned: No
Related trials for Eye Dryness
Not yet recruitingPhase 1
R-2487 in Patients With Sjogren's Syndrome (SjD)
Sjogren's Syndrome, Sjögren
RecruitingPhase 1
A Trial in Healthy Adult Participants and Adults With Autoimmune Diseases to Test How HBM7020 is Tolerated and How it Behaves in the Body
Rheumatoid Arthritis, Systemic Lupus Erythematosus
RecruitingObservational study
Pain Phenotyping of Rheumatic Diseases - An Observational Study
Rheumatic Diseases, Lupus Erythematosus, Systemic
RecruitingPhase 1/2
Autologous Transplantation of Induced Pluripotent Stem Cell-Derived Retinal Pigment Epithelium for Geographic Atrophy Associated With Age-Related Macular Degeneration
Dry Age-Related Macular Degeneration, Geographic Atrophy
RecruitingObservational study
The Pathogenesis and Natural History of Sjogren's Disease
Sjogren's Syndrome, Salivary Gland
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Multidose mosturizing solution DROP 0.4% and Multidose mosturizing solution Avizor Eye Drops 0.2% Preserved in people with Eye Dryness, run by Avizor SA.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 9 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Francisco Blazquez, MD, MsC ((+34) 983184734, fblazqueza@fundacion.uva.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in eye dryness symptoms (time frame: 1 month). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2025.