Clinical trial NCT04485533: Clinical Investigation to Assess the Efficacy and the Safety of VisuXL® Gel Administered in Patients Affected by Moderate DED
Official title: Clinical Investigation to Assess the Efficacy and the Safety of VisuXL® Ophthalmic Gel Administered in Patients Affected by Moderate Dry Eye Disease (DED): a Randomized, Cross Over, Double Blind Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Dry Eye Syndromes
Lead sponsor: VISUfarma SpA
Sponsor class: INDUSTRY
First posted: 2020-07-24
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Tear Break-Up Time (TBUT)
timeFrame: through study completion, an average of 2.5 months
Secondary outcomes:
measure: Stability of the tear film assessed by NIBUT (Non-invasive Break-Up Time)
timeFrame: through study completion, an average of 2.5 months
measure: Functional Visual Acuity (FVA)
timeFrame: through study completion, an average of 2.5 months
measure: Tear secretion
timeFrame: through study completion, an average of 2.5 months
measure: Burning, foreign body sensation, itching, and photophobia symptoms of DED assessed by Visual Analogue Scale (10 points VAS)
timeFrame: through study completion, an average of 2.5 months
measure: Conjunctival inflammation assessed by staining grade with Van Bijsterveld Scale
timeFrame: through study completion, an average of 2.5 months
measure: Corneal inflammation assessed by staining grade with SICCA Scale
timeFrame: through study completion, an average of 2.5 months
measure: Impact of DED on Everyday Life assessed by means of Quality of Life questionnaire IDEEL
timeFrame: through study completion, an average of 2.5 months
measure: Each of the three modules that are part of IDEEL questionnaire
timeFrame: through study completion, an average of 2.5 months
measure: Number of participants with treatment-related Adverse Events and Adverse Device Events assessed in a descriptive way
timeFrame: through study completion, an average of 2.5 months
Other outcomes:
Locations:
city: Brest
country: France
facility: Hôpital Morvan
state: Finistère
city: Milano
country: Italy
facility: ASST-Santi Paolo e Carlo-Presidio San Paolo
state: MI
city: Madrid
country: Spain
facility: Hospital Clínico San Carlos de Madrid
Study officials:
References: