Dry Eye Syndromes
Conditions
Brief summary
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).
Detailed description
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.
Interventions
DEVICEVisuXL® Gel
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.
DEVICEHYLO®
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
Sponsors
VISUfarma SpA
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patient Informed consent form (ICF) signed. * Males and Females aged ≥18 years at the time of the signature of ICF. * Patients with moderate dry eye disease (DED) according to IDEEL questionnaire (score ≥51 and ≤64) and diagnosed at least 3 months before enrolment. * No use of other tear substitutes in the 5 days prior to enrolment, except for refresh solutions. * TBUT value \<6 sec. * Willing to follow all study procedures, including attending all site visits, tests and examinations. * Women must agree to be using two forms of effective contraception, be post-menopausal from at least 12 months prior to trial entry, or surgically sterile.
Exclusion criteria
* Patients with a mild or severe dry eye disease (DED) according to IDEEL questionnaire (score ≤50 and ≥65, respectively). * Use of ophthalmologic products in the 14 days prior to enrolment, except for refresh solutions and stable glaucoma treatment. * No previous history or presence of any disease involving cornea or conjunctiva. * Sjӧgren syndrome. * History or active cicatricial conjunctivitis. * History of ocular surface burns. * Use of contact lenses. * Corneal refractive surgery 1 year post-operative. * Any ocular surgery in the previous 3 months preceding the study. * Unstable glaucoma (treatment changes in the last year). * Any macular or retinal disease that could impact visual acuity. * Best corrected visual acuity (BCVA) below 20/40. * Blepharitis treatment started less than 3 months before enrolment. * Neurological, neurodegenerative or cerebrovascular conditions. * Any clinically significant history of serious digestive tract, liver, kidney, cardiovascular, cancer or hematological disease. * Unstable treatment with systemic medications, such as diuretics, antihistamines, antidepressants, psychotropics, cholesterol lowering agents and beta-blockers. * Known hypersensitivity to one of the administered products. * Known drug and/or alcohol abuse. * Mental incapacity that precludes adequate understanding or cooperation. * Participation in another investigational study or blood donation within 1 month prior to ICF signature.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Tear Break-Up Time (TBUT) | through study completion, an average of 2.5 months | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Functional Visual Acuity (FVA) | through study completion, an average of 2.5 months | 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) |
| Tear secretion | through study completion, an average of 2.5 months | 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 |
| Burning, foreign body sensation, itching, and photophobia symptoms of DED assessed by Visual Analogue Scale (10 points VAS) | through study completion, an average of 2.5 months | 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). |
| Conjunctival inflammation assessed by staining grade with Van Bijsterveld Scale | through study completion, an average of 2.5 months | 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 |
| Stability of the tear film assessed by NIBUT (Non-invasive Break-Up Time) | through study completion, an average of 2.5 months | 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 |
| Impact of DED on Everyday Life assessed by means of Quality of Life questionnaire IDEEL | through study completion, an average of 2.5 months | 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 |
| Each of the three modules that are part of IDEEL questionnaire | through study completion, an average of 2.5 months | 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 |
| Number of participants with treatment-related Adverse Events and Adverse Device Events assessed in a descriptive way | through study completion, an average of 2.5 months | 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) |
| Corneal inflammation assessed by staining grade with SICCA Scale | through study completion, an average of 2.5 months | 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 |
Countries
France, Italy, Spain
Outcome results
None listed