Clinical Investigation to Assess the Efficacy and the Safety of VisuXL® Gel Administered in Patients Affected by Moderate DED

VISUfarma

Status: Unknown

Conditions: Dry Eye Syndromes

Treatments: Device: HYLO®; Device: VisuXL® Gel

Study type: Interventional

Funder types: Industry

Identifiers

NCT04485533

VF-OS-004/2019

Details and patient eligibility

About

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).

Full 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.

Enrollment: 90 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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90 participants in 2 patient groups

VisuXL® Gel/HYLO®

Experimental group

Description:

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).

Treatment:

Device: HYLO®

Device: VisuXL® Gel

HYLO®/VisuXL® Gel

Active Comparator group

Description:

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).

Treatment:

Device: HYLO®

Device: VisuXL® Gel