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| Name | Class |
|---|---|
| Instituto Universitario de OftalmobiologÃa Aplicada (Institute of Applied Ophthalmobiology) - IOBA | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Multidose mosturizing solution DROP 0.4% | Device | Ophthalmic mosturizing solution to be administered 1-4 times per day in both eyes |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Stability of the tear film | Measurement of tear film stability by Non-Invasive Break-Up Time (NIBUT). | 1 month |
| Ocular surface response to treatment - Oxford Scale (0 (Better) to 5 (Worse)) | Corneal staining with fluorescein, green lissamine and conjunctival hyperemia |
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INCLUSION CRITERIA:
Additionally, for Group 1 (Non contact lens users)
Additionally, for Group 2 (contact lens users)
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:
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):
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.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| 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 |
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| ID | Term |
|---|---|
| D014985 | Xerophthalmia |
| D015352 | Dry Eye Syndromes |
| ID | Term |
|---|---|
| D003229 | Conjunctival Diseases |
| D005128 | Eye Diseases |
| D007766 | Lacrimal Apparatus Diseases |
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| ID | Term |
|---|---|
| D011309 | Preservation, Biological |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D008919 | Investigative Techniques |
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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.
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Product and comparator have the same external and physical characteristics and the label is the same for both products except for expiry date
| Multidose mosturizing solution Avizor Eye Drops 0.2% Preserved | Device | Ophthalmic mosturizing solution to be administered 1-4 times per day in both eyes |
|
| 1 month |
| Tear evaporation | Assessed by evaporimetry | 1 month |
| Number of instillations per product | Comparison between the number of intimations of both products | 1 month |
| User satisfaction with the product | Numerical scale from 1 to 10 | 1 month |