An interventional study of VisuXL® Gel and HYLO® in Dry Eye Syndromes, sponsored by VISUfarma SpA. Status unknown at 3 sites in 3 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-07-24.
Sponsored by VISUfarma SpA · Not applicable, Interventional, and Treatment
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.
1,292 studies on the registry are indexed under Dry Eye Syndromes; 191 are open to participants now.
This study's planned enrollment of 90 is above the median of 60 across 1,077 interventional studies indexed under Dry Eye Syndromes.
Browse Dry Eye Syndromes studies →VISUfarma SpA is the lead sponsor of 11 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients treated with VisuXL® ophthalmic gel for the first 30 days (1 treatment period) and with HYLO® for the second 30 days (2 treatment period).
Device: VisuXL® Gel · Device: HYLO®
Patients treated with HYLO® for the first 30 days (1 treatment period) and with VisuXL® ophthalmic gel for the second 30 days (2 treatment period).
Device: VisuXL® Gel · Device: HYLO®
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
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
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
Plan to share: No
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VISUfarma SpA