Evaporative Dry EyeMALTESENCT04037969
Comparison of Tear Evaporation Rate With DAILIES TOTAL1 and Biotrue ONEday
A study testing Nesofilcon A and Delefilcon A in people with Evaporative Dry Eye, run by University of Waterloo at 1 site in Canada.
Trial summary
The purpose of this pilot study is to compare the effect of DAILIES TOTAL1, a low water content silicone hydrogel lens, and Biotrue ONEday, a high water content hydrogel lens, on the rate of tear evaporation. The study will also serve to validate the novel, in-house developed evaporimeter. Read more about this study
- Who is it for?
- Ages 17 years and olderHealthy volunteers can take part
- Conditions the study is for
- Evaporative Dry Eye
- What is being tested?
- Nesofilcon A and Delefilcon A
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- 7 Aug 2019to 26 Nov 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 17 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Is at least 17 years of age and has full legal capacity to volunteer;
- Has read and signed an information consent letter;
- Is willing and able to follow instructions and maintain the appointment schedule;
- Has worn soft contact lenses for a minimum of 6 months;
- Currently wears soft contact lenses for at least 4 days per week and 8 hours per day;
- Has an acceptable fit and comfort with both study contact lenses in the powers available;
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- Has less than or equal to 1.00DS difference between eyes in their habitual contact lenses;
- Is willing to be awake for at least 2 hours before visit 2;
- Is willing to not wear eye makeup on the day of visit 2 and 3;
- Is willing to not use eye drops or artificial tears on the day of visits 1, 2, and 3;
- Has a wearable pair of spectacles.
Who cannot join
- Is participating in any concurrent clinical or research study;
- Has any known active* ocular disease and/or infection;
- Has a systemic condition that in the opinion of the investigator may affect a study outcome variable;
- Is using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable;
- Has known sensitivity to sodium fluorescein dye;
- Is pregnant, lactating or planning a pregnancy at the time of enrolment (by verbal confirmation at the screening visit);
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- Is aphakic;
- Has undergone refractive error surgery;
- Has a known sensitivity to petroleum jelly (Vaseline);
- Has epilepsy and/or a sensitivity to flashing lights;
- Wears toric contact lenses;
- Has any physical impairment that would interfere with holding the evaporimeter;
- Has taken part in another research study within the last 14 days.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this pilot study is to compare the effect of DAILIES TOTAL1, a low water content silicone hydrogel lens, and Biotrue ONEday, a high water content hydrogel lens, on the rate of tear evaporation. The study will also serve to validate the novel, in-house developed evaporimeter.
- Conditions
- Evaporative Dry Eye
- Being tested
- Nesofilcon A, Delefilcon A
- 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.
Nesofilcon ADevice
Hydrogel contact lens for daily wear
Delefilcon ADevice
Silicone hydrogel contact lens for daily wear
| Study group | Role | What they receive |
|---|---|---|
| Nesofilcon A/Delefilcon A | Experimental | Nesofilcon A was worn in right eye and delefilcon A worn in the left eye. Receives: Device: Nesofilcon A; Device: Delefilcon A |
| Delefilcon A/Nesofilcon A | Experimental | Delefilcon A was worn in right eye and Nesofilcon A worn in the left eye. Receives: Device: Nesofilcon A; Device: Delefilcon A |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tear Evaporation Rate With Nesofilcon A
Tear film evaporation rate (% relative humidity per second) was performed using a novel evaporimeter as a non-invasive measurement of tear film evaporation. The slope was calculated from the change in humidity between 7 to 17.5 seconds while the eye was open and between 10 to 17.5 seconds when the eye was closed. Data from the both eyes were analyzed.
Measured: Baseline, 15 minutes post-contact lens, 6 hours post-contact lens
Tear Evaporation Rate With Delefilcon A
Tear film evaporation rate (% relative humidity per second) was performed using a novel evaporimeter as a non-invasive measurement of tear film evaporation. The slope was calculated from the change in humidity between 7 to 17.5 seconds while the eye was open and between 10 to 17.5 seconds when the eye was closed. Data from the both eyes were analyzed.
Measured: Baseline, 15 minutes post-contact lens, 6 hours post-contact lens
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2019
- Study start7 Aug 2019
- Primary completion26 Nov 2019
- Study completion26 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Evaporative Dry EyeStudies 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Waterloo
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04037969
- Sponsor's protocol ID
- 41195
- Acronym
- MALTESE
- Status last verified
- Mar 2021
- First submitted
- 26 Jul 2019
- Last updated
- 23 Apr 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Tear Evaporation Rate With DAILIES TOTAL1 and Biotrue ONEday
- ClinicalTrials.gov ID
- NCT04037969
- Acronym / sponsor ID
- MALTESE / 41195
- Conditions
- Evaporative Dry Eye
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of WaterlooUniversity, hospital or other
- Study start
- 7 Aug 2019 (actual)
- Primary completion
- 26 Nov 2019 (actual)
- Study completion
- 26 Nov 2019 (actual)
- First posted
- 30 Jul 2019 (actual)
- Results
- Posted 23 Apr 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this pilot study is to compare the effect of DAILIES TOTAL1, a low water content silicone hydrogel lens, and Biotrue ONEday, a high water content hydrogel lens, on the rate of tear evaporation. The study will also serve to validate the novel, in-house developed evaporimeter.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nesofilcon A/Delefilcon A | Experimental | Device: Nesofilcon A, Device: Delefilcon ANesofilcon A was worn in right eye and delefilcon A worn in the left eye. |
| Delefilcon A/Nesofilcon A | Experimental | Device: Nesofilcon A, Device: Delefilcon ADelefilcon A was worn in right eye and Nesofilcon A worn in the left eye. |
Who may qualify
- Ages
- 17 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (11 listed)
- Is at least 17 years of age and has full legal capacity to volunteer;
- Has read and signed an information consent letter;
- Is willing and able to follow instructions and maintain the appointment schedule;
- Has worn soft contact lenses for a minimum of 6 months;
- Currently wears soft contact lenses for at least 4 days per week and 8 hours per day;
Key exclusion criteria (13 listed)
- Is participating in any concurrent clinical or research study;
- Has any known active* ocular disease and/or infection;
- Has a systemic condition that in the opinion of the investigator may affect a study outcome variable;
- Is using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable;
- Has known sensitivity to sodium fluorescein dye;
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 |
|---|---|---|
| Nesofilcon AHydrogel contact lens for daily wear | Device | Delefilcon A/Nesofilcon A, Nesofilcon A/Delefilcon A |
| Delefilcon ASilicone hydrogel contact lens for daily wear | Device | Delefilcon A/Nesofilcon A, Nesofilcon A/Delefilcon A |
Primary outcome
Tear Evaporation Rate With Nesofilcon A
Time frame: Baseline, 15 minutes post-contact lens, 6 hours post-contact lens
Tear film evaporation rate (% relative humidity per second) was performed using a novel evaporimeter as a non-invasive measurement of tear film evaporation. The slope was calculated from the change in humidity between 7 to 17.5 seconds while the eye was open and between 10 to 17.5 seconds when the eye was closed. Data from the both eyes were analyzed.
Tear Evaporation Rate With Delefilcon A
Time frame: Baseline, 15 minutes post-contact lens, 6 hours post-contact lens
Tear film evaporation rate (% relative humidity per second) was performed using a novel evaporimeter as a non-invasive measurement of tear film evaporation. The slope was calculated from the change in humidity between 7 to 17.5 seconds while the eye was open and between 10 to 17.5 seconds when the eye was closed. Data from the both eyes were analyzed.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nesofilcon A and Delefilcon A in people with Evaporative Dry Eye, run by University of Waterloo at 1 site in Canada.
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 11 inclusion and 13 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 23 Apr 2021. 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 Canada. 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?
Yes. Results are posted in the registry (first posted 23 Apr 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Evaporation Rate With Nesofilcon A (time frame: Baseline, 15 minutes post-contact lens, 6 hours post-contact lens). The study lists 2 primary outcomes in all. 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 23 Apr 2021.