Clinical Trial for the Evaluation of the Safety and Efficacy of a Moisturizing Solution With Hyaluronic Acid Drop 0.4%
Trial Snapshot
- Phase
- Phase 3
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 79
- Primary Endpoint
- Changes in best corrected visual acuity (safety outcome)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Masking Description
Product and comparator have the same external and physical characteristics and the label is the same for both products except for expiry date
Eligibility Criteria
- Ages
- 18 Years to 99 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Contact lens users with eye dryness
Contact lens users that have eye dryness symptoms. Both treatments will be administered, as it is a crossover study.
Intervention: Multidose mosturizing solution DROP 0.4% (Device)
Contact lens users with eye dryness
Contact lens users that have eye dryness symptoms. Both treatments will be administered, as it is a crossover study.
Intervention: Multidose mosturizing solution Avizor Eye Drops 0.2% Preserved (Device)
Non contact lens user with eye dryness
Non contact lens patients with eye dryness symptoms. Both treatments will be administered, as it is a crossover study.
Intervention: Multidose mosturizing solution DROP 0.4% (Device)
Non contact lens user with eye dryness
Non contact lens patients with eye dryness symptoms. Both treatments will be administered, as it is a crossover study.
Intervention: Multidose mosturizing solution Avizor Eye Drops 0.2% Preserved (Device)
Outcomes
Primary Outcomes
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).
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
Serious adverse events
Time Frame: 1 month
All local and systemic serious adverse events
Ocular and peri orbital adverse events
Time Frame: 1 month
All local adverse events reported
Secondary Outcomes
- Tear evaporation(1 month)
- Number of instillations per product(1 month)
- User satisfaction with the product(1 month)
- Stability of the tear film(1 month)
- Ocular surface response to treatment - Oxford Scale (0 (Better) to 5 (Worse))(1 month)