This is a post-market, european multicenter study. This is a randomized, cross-over, double blind study with competitive enrolment, aimed to enroll a total of 90 patients with a diagnosis of moderate dry eye disease (DED).
The purpose of the study is to evaluate the non-inferiority of the new treatment versus the comparator. Patients, after signing the Informed Consent, will enter into a 1-week screening phase during which the baseline tests will be conducted. Baseline (V0), Day 30 ± 1 week (V1), Day 38 ± 2 days (V2), Day 68 ±1 week (V3) of treatment. Between V1 and V2 one week of wash out should be performed. Of note, all ophthalmologic evaluations listed in the Flow-Chart will be performed on both eyes of the patient.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
90
VisuXL® ophthalmic gel, available in a multidose 10ml bottle without preservatives based on Coenzyme Q10, Vitamin E TPGS and cross-linked sodium carboxymethylcellulose. Dose/dosage: 1 drop per eye twice a day.
HYLO® ophthalmic solution, a phosphate- and preservative-free sterile eye drops containing 2 mg/ml of hyaluronic acid sodium salt, a citrate buffer, sorbitol and water. Dose/dosage: 1 drop per eye twice a day
Hôpital Morvan
Brest, Finistère, France
ASST-Santi Paolo e Carlo-Presidio San Paolo
Milan, MI, Italy
Hospital Clínico San Carlos de Madrid
Madrid, Spain
Tear Break-Up Time (TBUT)
To evaluate the effect of treatment with VisuXL® GEL versus HYLO® on the stability of the tear film by Tear Break-Up Time (TBUT) in patients affected by moderate dry eye disease (DED).
Time frame: through study completion, an average of 2.5 months
Stability of the tear film assessed by NIBUT (Non-invasive Break-Up Time)
To evaluate the time-related effects of treatment with VisuXL® GEL versus HYLO® in patients affected by moderate dry eye disease (DED) on Stability of the tear film
Time frame: through study completion, an average of 2.5 months
Functional Visual Acuity (FVA)
To evaluate the time-related effects of treatment with VisuXL® GEL versus HYLO® in patients affected by moderate dry eye disease (DED) on Functional Visual Acuity (FVA)
Time frame: through study completion, an average of 2.5 months
Tear secretion
To evaluate the time-related effects of treatment with VisuXL® GEL versus HYLO® in patients affected by moderate dry eye disease (DED) on Tear secretion
Time frame: through study completion, an average of 2.5 months
Burning, foreign body sensation, itching, and photophobia symptoms of DED assessed by Visual Analogue Scale (10 points VAS)
To evaluate the time-related effects of treatment with VisuXL® GEL versus HYLO® in patients affected by moderate dry eye disease (DED) on Burning, foreign body sensation, itching, and photophobia symptoms of DED. (VAS: scale where patient has to specify level of satisfaction by indicating a position along a continuous line between two end-points (0 - 10). 0 indicates no satisfaction while 10 represents the highest level).
Time frame: through study completion, an average of 2.5 months
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Conjunctival inflammation assessed by staining grade with Van Bijsterveld Scale
To evaluate the time-related effects of treatment with VisuXL® GEL versus HYLO® in patients affected by moderate dry eye disease (DED) on Conjunctival and corneal inflammation
Time frame: through study completion, an average of 2.5 months
Corneal inflammation assessed by staining grade with SICCA Scale
To evaluate the time-related effects of treatment with VisuXL® GEL versus HYLO® in patients affected by moderate dry eye disease (DED) on Conjunctival and corneal inflammation
Time frame: through study completion, an average of 2.5 months
Impact of DED on Everyday Life assessed by means of Quality of Life questionnaire IDEEL
To evaluate the time-related effects of treatment with VisuXL® GEL versus HYLO® in patients affected by moderate dry eye disease (DED) on Impact of DED on Everyday Life assessed by means of Quality of Life questionnaire IDEEL
Time frame: through study completion, an average of 2.5 months
Each of the three modules that are part of IDEEL questionnaire
To evaluate the time-related effects of treatment with VisuXL® GEL versus HYLO® in patients affected by moderate dry eye disease (DED) on Each of the three modules that are part of IDEEL questionnaire
Time frame: through study completion, an average of 2.5 months
Number of participants with treatment-related Adverse Events and Adverse Device Events assessed in a descriptive way
To evaluate the time-related effects of treatment with VisuXL® GEL versus HYLO® in patients affected by moderate dry eye disease (DED) on Medical devices' safety and tolerability: * Allergy to any device compound * Any other adverse event (AE) * Adverse device effects (ADEs) -Undetected/unforeseen manufacturing ADE which might bring to application procedure errors - * Contamination of the device nozzle and possibility to contaminate both eyes * Interaction with any other permitted local administered therapy * Vital signs: blood pressure (BP), heart rate (HR), respiratory rate (RR)
Time frame: through study completion, an average of 2.5 months