Ocular DiscomfortNCT03844737
Evaluation of the VisuXL® Performance on Ocular Surface Discomfort
A study testing VisuXL® in people with Ocular Discomfort, run by VISUfarma SpA at 1 site in Italy.
Trial summary
VisuXL® is a medical device that is effective in various ocular surface disorders (ocular dryness, changes in the continuity of the corneal and conjunctival surface, environmental stress, exposure to UV and ionizing radiation, prolonged use of videoterminals, etc.). Read more about this study
- Who is it for?
- Ages 14 to 33 years, men only
- Conditions the study is for
- Ocular Discomfort
- What is being tested?
- VisuXL®
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteItaly
- Study dates
- 8 Oct 2018to 6 Dec 2018
- 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 14 to 33 years
- Men only
- No healthy volunteers
- Child, Adult
Who may be able to join
- Male subjects aged 14 to 33 years
- Schirmer test I> 10 mm at 5 '
- Willingness to participate in the study and possibility to sign the ICF; for athletes aged <18 years: parents' agreement for the participation of the child in the study
- Discomfort of the ocular surface
Who cannot join
- Pathologies of the anterior segment
- Diagnosis of autoimmune diseases (eg SEL, Sjogren)
- Diagnosis of metabolic diseases (eg diabetes, thyroid malfunction/disorder)
- Entropion
- Trichiasis
- Deficiency of androgens sex hormones
Show all 11Show fewer
- Taking medications that can interfere with the secretion of the lacrimal gland
- Connective tissue disease
- Prior eye surgery
- Hypersensitivity to the active ingredients contained in VisuXL®
- Use of artificial tears in the 15 days before the start of the study
Trial locations and contacts
1 site in 1 country.
Italy1 site
UO Oculistica, Fondazione Policlinico Universitario A. Gemelli
Roma, 00168
About this study
Official title: Evaluation of the VisuXL® Performance on Ocular Surface Discomfort, in Professional Water-polo Athletes Exposed to Pool Water for Prolonged Periods
VisuXL® is a medical device that is effective in various ocular surface disorders (ocular dryness, changes in the continuity of the corneal and conjunctival surface, environmental stress, exposure to UV and ionizing radiation, prolonged use of videoterminals, etc.). Therefore, the aim of this study is to demonstrate that the clinical benefits and quality of life of the swimmers, exposed for a long time to water added with chlorine, are strongly linked to the unique composition of the long-term VisuXL® medical device.
Read the detailed description
This is a post-market, monocentric, open-label, randomized study of superiority, with the untreated eye considered as a comparator for the eye treated with VisuXL®, to demonstrate the effectiveness of VisuXL® in professional water-polo athletes exposed to pool water after VisuXL® ocular instillations for 2 months. Considered the category of subjects to study, the study is to be considered a fact-finding pilot study in a particular category of subjects.
The study population will be enrolled only after having signed the informed consent; in each enrolled subject, only one eye will be treated with VisuXL®, while the other no, as will be considered the comparator, so the two randomized groups will be divided by treated eyes:
- Untreated control eye
- Eye treated with VisuXL®
Each enrolled subject will be instructed to instill, TID, 1-2 drops of VisuXL® always in the same eye during the entire study, according to the present modality:
- Morning
- Before training (at least one hour before entering the pool)
- After training (maximum one hour after the end of the activity) Subjects will continue to instil 1-2 drops of VisuXL®, TID, always in the same eye, even in days without training (including weekends).
- Conditions
- Ocular Discomfort
- Being tested
- VisuXL®
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VisuXL®Device
Treatment of discomfort forms of the ocular surface, in professional water-polo athletes exposed to pool water for prolonged periods.
| Study group | Role | What they receive |
|---|---|---|
| VisuXL® Treatment | Experimental | Not described Receives: Device: VisuXL® |
What is being measured
The primary outcome is the main question the study is designed to answer.
break-up time (BUT)
change over time in tear film break-up time (BUT)
Measured: measured at week 1, 2, 4 and 8 versus baseline
Secondary outcomes (7)
coloration of the ocular surface
Analysis to evaluate the differences over time between the two groups on coloration of the ocular surface (corneal and conjunctival) with fluorescein
Measured: measured at week 1, 2, 4 and 8 versus baseline
Schirmer I test at 5 min (ST) (without anesthesia)
Analysis to evaluate the differences over time between the two groups on Schirmer I test at 5 min (ST) (without anesthesia)
Measured: measured at week 1, 2, 4 and 8 versus baseline
Number of beating of eyelashes per minute
Analysis to evaluate the differences over time between the two groups on number of beating of eyelashes per minute
Measured: measured at week 1, 2, 4 and 8 versus baseline
Tear osmolarity test
Analysis to evaluate the differences over time between the two groups on tear osmolarity test
Measured: measured at week 1, 2, 4 and 8 versus baseline
Evaluation of visual acuity
Analysis to evaluate the differences over time between the two groups on evaluation of visual acuity
Measured: measured at week 1, 2, 4 and 8 versus baseline
Questionnaire scores (OSDI)
Analysis to evaluate the differences over time between the two groups on questionnaire scores (OSDI). The overall Ocular Surface Disease score defined the ocular surface as normal (0-12 points) or as having mild (13-22 points), moderate (23-32 points), or severe (33-100 points) disease.
Measured: measured at week 1, 2, 4 and 8 versus baseline
Subject satisfaction (10 points on the VAS scale)
Analysis to evaluate the differences over time between the two groups on subject satisfaction.
(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: measured at week 1, 2, 4 and 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2019
- Study start8 Oct 2018
- Primary completion6 Dec 2018
- Study completion6 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ocular DiscomfortStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- VISUfarma SpA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03844737
- Sponsor's protocol ID
- VF-OS-003/2018
- Status last verified
- Feb 2019
- First submitted
- 31 Jan 2019
- Last updated
- 18 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the VisuXL® Performance on Ocular Surface Discomfort, in Professional Water-polo Athletes Exposed to Pool Water for Prolonged Periods
- ClinicalTrials.gov ID
- NCT03844737
- Acronym / sponsor ID
- VF-OS-003/2018
- Conditions
- Ocular Discomfort
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- VISUfarma SpAIndustry (pharma, biotech, devices)
- Study start
- 8 Oct 2018 (actual)
- Primary completion
- 6 Dec 2018 (actual)
- Study completion
- 6 Dec 2018 (actual)
- First posted
- 18 Feb 2019 (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.
VisuXL® is a medical device that is effective in various ocular surface disorders (ocular dryness, changes in the continuity of the corneal and conjunctival surface, environmental stress, exposure to UV and ionizing radiation, prolonged use of videoterminals, etc.). Therefore, the aim of this study is to demonstrate that the clinical benefits and quality of life of the swimmers, exposed for a long time to water added with chlorine, are strongly linked to the unique composition of the long-term VisuXL® medical device.
Detailed description
This is a post-market, monocentric, open-label, randomized study of superiority, with the untreated eye considered as a comparator for the eye treated with VisuXL®, to demonstrate the effectiveness of VisuXL® in professional water-polo athletes exposed to pool water after VisuXL® ocular instillations for 2 months. Considered the category of subjects to study, the study is to be considered a fact-finding pilot study in a particular category of subjects.
The study population will be enrolled only after having signed the informed consent; in each enrolled subject, only one eye will be treated with VisuXL®, while the other no, as will be considered the comparator, so the two randomized groups will be divided by treated eyes:
- Untreated control eye
- Eye treated with VisuXL®
Each enrolled subject will be instructed to instill, TID, 1-2 drops of VisuXL® always in the same eye during the entire study, according to the present modality:
- Morning
- Before training (at least one hour before entering the pool)
- After training (maximum one hour after the end of the activity) Subjects will continue to instil 1-2 drops of VisuXL®, TID, always in the same eye, even in days without training (including weekends).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| VisuXL® Treatment | Experimental | Device: VisuXL® |
Who may qualify
- Ages
- 14 to 33 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Male subjects aged 14 to 33 years
- Schirmer test I> 10 mm at 5 '
- Willingness to participate in the study and possibility to sign the ICF; for athletes aged <18 years: parents' agreement for the participation of the child in the study
- Discomfort of the ocular surface
Key exclusion criteria (11 listed)
- Pathologies of the anterior segment
- Diagnosis of autoimmune diseases (eg SEL, Sjogren)
- Diagnosis of metabolic diseases (eg diabetes, thyroid malfunction/disorder)
- Entropion
- Trichiasis
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®Treatment of discomfort forms of the ocular surface, in professional water-polo athletes exposed to pool water for prolonged periods. | Device | VisuXL® Treatment |
Primary outcome
break-up time (BUT)
Time frame: measured at week 1, 2, 4 and 8 versus baseline
change over time in tear film break-up time (BUT)
7 secondary outcomes
coloration of the ocular surface
Time frame: measured at week 1, 2, 4 and 8 versus baseline
Schirmer I test at 5 min (ST) (without anesthesia)
Time frame: measured at week 1, 2, 4 and 8 versus baseline
Number of beating of eyelashes per minute
Time frame: measured at week 1, 2, 4 and 8 versus baseline
Tear osmolarity test
Time frame: measured at week 1, 2, 4 and 8 versus baseline
Evaluation of visual acuity
Time frame: measured at week 1, 2, 4 and 8 versus baseline
Questionnaire scores (OSDI)
Time frame: measured at week 1, 2, 4 and 8 versus baseline
Subject satisfaction (10 points on the VAS scale)
Time frame: measured at week 1, 2, 4 and 8
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2019.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VisuXL® in people with Ocular Discomfort, run by VISUfarma SpA at 1 site in Italy.
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 4 inclusion and 11 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: finished, as of the sponsor's last update on 18 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
break-up time (BUT) (time frame: measured at week 1, 2, 4 and 8 versus baseline). 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 18 Feb 2019.