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

NCT ID: NCT04485533

Last Updated: 2020-07-24

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-07-06
• Study Completion Date: 2021-04-30

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.

Conditions

Dry Eye Syndromes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

VisuXL® Gel/HYLO®

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).

Group Type: EXPERIMENTAL

VisuXL® Gel

Intervention Type: DEVICE

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®

Intervention Type: DEVICE

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

HYLO®/VisuXL® Gel

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).

Group Type: ACTIVE_COMPARATOR

VisuXL® Gel

Intervention Type: DEVICE

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®

Intervention Type: DEVICE

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

Interventions

VisuXL® 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.

Intervention Type: DEVICE

HYLO®

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

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

VISUfarma SpA

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hôpital Morvan

Brest, Finistère, France

ASST-Santi Paolo e Carlo-Presidio San Paolo

Milan, MI, Italy

Hospital Clínico San Carlos de Madrid

Madrid, , Spain

Countries

France; Italy; Spain

Other Identifiers

VF-OS-004/2019

Identifier Type: -

Identifier Source: org_study_id