Back to resultsClinical Investigation to Assess the Efficacy and the Safety of VisuXL® Gel Administered in Patients Affected by Moderate DED
Primary Purpose
Dry Eye Syndromes
Status
Unknown status
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
VisuXL® Gel
HYLO®
Sponsored by
About this trial
This is an interventional treatment trial for Dry Eye Syndromes
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.
Sites / Locations
- Hôpital Morvan
- ASST-Santi Paolo e Carlo-Presidio San Paolo
- Hospital Clínico San Carlos de Madrid
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
VisuXL® Gel/HYLO®
HYLO®/VisuXL® Gel
Arm 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).
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).
Outcomes
Primary Outcome Measures
Tear Break-Up Time (TBUT)
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 Outcome Measures
Stability of the tear film assessed by NIBUT (Non-invasive Break-Up Time)
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
Functional Visual Acuity (FVA)
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
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)
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
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
Corneal inflammation assessed by staining grade with SICCA Scale
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
Impact of DED on Everyday Life assessed by means of Quality of Life questionnaire IDEEL
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
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
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)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04485533
Brief Title
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
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Unknown status
Study Start Date
July 6, 2020 (Actual)
Primary Completion Date
April 30, 2021 (Anticipated)
Study Completion Date
April 30, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VISUfarma SpA
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Eye Syndromes
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
90 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
VisuXL® Gel/HYLO®
Arm Type
Experimental
Arm 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).
Arm Title
HYLO®/VisuXL® Gel
Arm Type
Active Comparator
Arm 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).
Intervention Type
Device
Intervention Name(s)
VisuXL® Gel
Intervention Description
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
Intervention Name(s)
HYLO®
Intervention Description
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
Primary Outcome Measure Information:
Title
Tear Break-Up Time (TBUT)
Description
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).
Time Frame
through study completion, an average of 2.5 months
Secondary Outcome Measure Information:
Title
Stability of the tear film assessed by NIBUT (Non-invasive Break-Up Time)
Description
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
Time Frame
through study completion, an average of 2.5 months
Title
Functional Visual Acuity (FVA)
Description
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)
Time Frame
through study completion, an average of 2.5 months
Title
Tear secretion
Description
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
Time Frame
through study completion, an average of 2.5 months
Title
Burning, foreign body sensation, itching, and photophobia symptoms of DED assessed by Visual Analogue Scale (10 points VAS)
Description
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).
Time Frame
through study completion, an average of 2.5 months
Title
Conjunctival inflammation assessed by staining grade with Van Bijsterveld Scale
Description
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
Time Frame
through study completion, an average of 2.5 months
Title
Corneal inflammation assessed by staining grade with SICCA Scale
Description
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
Time Frame
through study completion, an average of 2.5 months
Title
Impact of DED on Everyday Life assessed by means of Quality of Life questionnaire IDEEL
Description
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
Time Frame
through study completion, an average of 2.5 months
Title
Each of the three modules that are part of IDEEL questionnaire
Description
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
Time Frame
through study completion, an average of 2.5 months
Title
Number of participants with treatment-related Adverse Events and Adverse Device Events assessed in a descriptive way
Description
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)
Time Frame
through study completion, an average of 2.5 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Hôpital Morvan
City
Brest
State/Province
Finistère
ZIP/Postal Code
29200
Country
France
Facility Name
ASST-Santi Paolo e Carlo-Presidio San Paolo
City
Milano
State/Province
MI
ZIP/Postal Code
20142
Country
Italy
Facility Name
Hospital Clínico San Carlos de Madrid
City
Madrid
ZIP/Postal Code
28040
Country
Spain
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Clinical Investigation to Assess the Efficacy and the Safety of VisuXL® Gel Administered in Patients Affected by Moderate DED
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