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

VISUfarma SpA3 sites in 3 countries90 target enrollmentJuly 6, 2020

ConditionsDry Eye Syndromes

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Dry Eye Syndromes
Sponsor: VISUfarma SpA
Enrollment: 90
Locations: 3
Primary Endpoint: Tear Break-Up Time (TBUT)
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

July 6, 2020

End Date

April 30, 2021

Last Updated

5 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

VISUfarma SpA

Responsible Party

Sponsor

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).

Outcomes

Primary Outcomes

Tear Break-Up Time (TBUT)

Time Frame: 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 Outcomes

Functional Visual Acuity (FVA)(through study completion, an average of 2.5 months)
Tear secretion(through study completion, an average of 2.5 months)
Stability of the tear film assessed by NIBUT (Non-invasive Break-Up Time)(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)(through study completion, an average of 2.5 months)
Conjunctival inflammation assessed by staining grade with Van Bijsterveld Scale(through study completion, an average of 2.5 months)
Corneal inflammation assessed by staining grade with SICCA Scale(through study completion, an average of 2.5 months)
Impact of DED on Everyday Life assessed by means of Quality of Life questionnaire IDEEL(through study completion, an average of 2.5 months)
Each of the three modules that are part of IDEEL questionnaire(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(through study completion, an average of 2.5 months)