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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
79
Ophthalmic mosturizing solution to be administered 1-4 times per day in both eyes
Ophthalmic mosturizing solution to be administered 1-4 times per day in both eyes
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
Time frame: 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
Time frame: 1 month
Changes in best corrected visual acuity (safety outcome)
Best corrected visual acuity tested with ETDRS (early treatment for diabetes retinopathy study).
Time frame: 1 month
Ocular and peri orbital adverse events
All local adverse events reported
Time frame: 1 month
Serious adverse events
All local and systemic serious adverse events
Time frame: 1 month
Stability of the tear film
Measurement of tear film stability by Non-Invasive Break-Up Time (NIBUT).
Time frame: 1 month
Ocular surface response to treatment - Oxford Scale (0 (Better) to 5 (Worse))
Corneal staining with fluorescein, green lissamine and conjunctival hyperemia
Time frame: 1 month
Tear evaporation
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Assessed by evaporimetry
Time frame: 1 month
Number of instillations per product
Comparison between the number of intimations of both products
Time frame: 1 month
User satisfaction with the product
Numerical scale from 1 to 10
Time frame: 1 month