Dry Eye SyndromesNCT04485533
Clinical Investigation to Assess the Efficacy and the Safety of VisuXL® Gel Administered in Patients Affected by Moderate DED
A study testing VisuXL® Gel and HYLO® in people with Dry Eye Syndromes, run by VISUfarma SpA at 3 sites in 3 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dry Eye Syndromes
- What is being tested?
- VisuXL® Gel and HYLO®
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 3 sitesin 3 countries
- Study dates
- 6 Jul 2020to 30 Apr 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 20Show fewer
- 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 locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
About this study
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
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).
Read the 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
- Being tested
- VisuXL® Gel, HYLO®
- Medical subject headings
- Dry Eye Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VisuXL® GelDevice
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®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
| Study group | Role | What they receive |
|---|---|---|
| VisuXL® Gel/HYLO® | Experimental | 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). Receives: Device: VisuXL® Gel; Device: HYLO® |
| HYLO®/VisuXL® Gel | Active comparator | 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). Receives: Device: VisuXL® Gel; Device: HYLO® |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: through study completion, an average of 2.5 months
Secondary outcomes (9)
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
Measured: through study completion, an average of 2.5 months
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)
Measured: through study completion, an average of 2.5 months
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
Measured: 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)
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).
Measured: through study completion, an average of 2.5 months
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
Measured: through study completion, an average of 2.5 months
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
Measured: through study completion, an average of 2.5 months
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
Measured: through study completion, an average of 2.5 months
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
Measured: 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
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)
Measured: through study completion, an average of 2.5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2020
- Study start6 Jul 2020
- Primary completion30 Apr 2021 (estimated)
- Study completion30 Apr 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry Eye SyndromesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- VISUfarma SpA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04485533
- Sponsor's protocol ID
- VF-OS-004/2019
- Status last verified
- Jul 2020
- First submitted
- 2 Jun 2020
- Last updated
- 24 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04485533
- Acronym / sponsor ID
- VF-OS-004/2019
- Conditions
- Dry Eye Syndromes
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- VISUfarma SpAIndustry (pharma, biotech, devices)
- Study start
- 6 Jul 2020 (actual)
- Primary completion
- 30 Apr 2021 (estimated)
- Study completion
- 30 Apr 2021 (estimated)
- First posted
- 24 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VisuXL® Gel/HYLO® | Experimental | Device: VisuXL® Gel, Device: 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). |
| HYLO®/VisuXL® Gel | Active comparator | Device: VisuXL® Gel, Device: HYLO®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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (20 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VisuXL® GelVisuXL® 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. | Device | HYLO®/VisuXL® Gel, VisuXL® Gel/HYLO® |
| 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 | Device | HYLO®/VisuXL® Gel, VisuXL® Gel/HYLO® |
Primary outcome
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).
9 secondary outcomes
Stability of the tear film assessed by NIBUT (Non-invasive Break-Up Time)
Time frame: through study completion, an average of 2.5 months
Functional Visual Acuity (FVA)
Time frame: through study completion, an average of 2.5 months
Tear secretion
Time frame: 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)
Time frame: through study completion, an average of 2.5 months
Conjunctival inflammation assessed by staining grade with Van Bijsterveld Scale
Time frame: through study completion, an average of 2.5 months
Corneal inflammation assessed by staining grade with SICCA Scale
Time frame: through study completion, an average of 2.5 months
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
Each of the three modules that are part of IDEEL questionnaire
Time frame: 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
Time frame: through study completion, an average of 2.5 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VisuXL® Gel and HYLO® in people with Dry Eye Syndromes, run by VISUfarma SpA at 3 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France, Italy, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tear Break-Up Time (TBUT) (time frame: through study completion, an average of 2.5 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2020.