Evaporative Dry EyePhase 4BULLDOGNCT04091581

Comparison of Tear Evaporation Rate With Systane Complete in Dry Eye and Non-Dry Eye

A Phase 4 study testing Systane Complete in people with Evaporative Dry Eye, run by University of Waterloo at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The objective of the study is to compare the rate of tear evaporation, measured with a novel evaporimeter, before and for one hour after an eye drop containing nano-sized oil droplets has been instilled. Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Evaporative Dry Eye
What is being tested?: Systane Complete
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 21 participants
Where: 1 siteCanada
Study dates: 21 Nov 2019to 6 Feb 2020
Phase: Phase 4
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 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Is at least 18 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;
Is willing to be awake for at least 2 hours before visit 2;
Is willing not to wear eye makeup on the day of visit 2;
Is willing not to use eye drops or artificial tears on the days of visits 1 or 2;

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Group specific criteria:
Dry eye participant group: Symptoms: OSDI ≥ 13 and Signs: NIKBUT ≤ 5 s in the worst eye
Non-dry eye participant group: Symptoms: OSDI < 13 and Signs: NIKBUT ≥ 10 s in the worst eye

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 undergone ocular surgery in the last 6 months;
Has punctal plugs;
Has a known sensitivity to Systane eye drops (including Systane Balance, Systane Complete, Systane Gel Drops, Systane Ultra, etc.)
Has a known sensitivity to petroleum jelly (Vaseline);
Has epilepsy and/or sensitivity to flashing lights;
Has worn contact lenses within the past month or is planning to wear contact lenses during the study;
Has any physical impairment that would interfere with holding the evaporimeter;
Has taken part in another clinical research study involving ocular drops or treatments within the last 14 days; * For the purposes of this study, active ocular disease is defined as infection or inflammation which requires therapeutic treatment. Mild (i.e. not considered clinically relevant) lid abnormalities (blepharitis, meibomian gland dysfunction, papillae), corneal and conjunctival staining and dry eye are not considered active ocular disease. Neovascularization and corneal scars are the result of previous hypoxia, infection or inflammation and are therefore not active.

Trial locations and contacts

1 site in 1 country.

Canada1 site

Centre for Ocular Research & Education
Waterloo, Ontario, N2L 3G1

Other trials in Canada

About this study

Conditions: Evaporative Dry Eye
Being tested: Systane Complete
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.

Systane CompleteDrug
Systane Complete will be instilled and rate of evaporation assessed before and after.

Study groups in NCT04091581
Study group	Role	What they receive
Non-Dry Eye	Experimental	Instill eye drop and perform followup assessments on people with a Ocular Surface Disease Index score <13 and a non-invasive Keratograph break-up time of >/= 10 seconds in the worst eye Receives: Drug: Systane Complete
Dry Eye	Experimental	Instill eye drop and perform followup assessments on people with an Ocular Surface Disease Index score >/= 13 and a non-invasive Keratograph break-up time </= 5 seconds in the worst eye Receives: Drug: Systane Complete

What is being measured

The primary outcome is the main question the study is designed to answer.

Tear Evaporation Rate
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 right eye was analyzed.
Measured: Baseline (Prior to instillation); 10, 30 and 60 minutes post instillation of eye drop

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

21 Nov 20196 Feb 2020

First posted17 Sep 2019
Study start21 Nov 2019
Primary completion6 Feb 2020
Study completion6 Feb 2020

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 4
Primary purpose: Diagnosis
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 21 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04091581
Sponsor's protocol ID: 41327
Acronym: BULLDOG
Status last verified: Jun 2022
First submitted: 13 Sep 2019
Last updated: 22 Jun 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingPhase 4
Evaporative Dry Eye
Dry Eye, Evaporative Dry Eye
Active, not recruitingObservational study
Study for Remote Investigation of Evaporative Dry Eye Disease
Evaporative Loss Dry Eye Disease
Enrolling by invitation
Microbiome-Focused Food Supplement for Evaporative Dry Eye Due to Meibomian Gland Dysfunction
Dry Eye, Evaporative Dry Eye Disease
Active, not recruiting
Comparative Efficacy of Lipid Based Artificial Tears vs Aqueous Based Artificial Tears in Managing EDE
Evaporative Dry Eye
Not yet recruiting
Efficacy of Lipid-containing Artificial Tears in the Treatment of Dry Eye
Dry Eye Disease, Dry Eye

All Evaporative Dry Eye trials

Study at a glance

From the registry record, last updated by the sponsor on 22 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Comparison of Tear Evaporation Rate With Systane Complete in Dry Eye and Non-Dry Eye
ClinicalTrials.gov ID: NCT04091581
Acronym / sponsor ID: BULLDOG / 41327
Conditions: Evaporative Dry Eye
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 21 participants (actual)
Lead sponsor: University of WaterlooUniversity, hospital or other
Study start: 21 Nov 2019 (actual)
Primary completion: 6 Feb 2020 (actual)
Study completion: 6 Feb 2020 (actual)
First posted: 17 Sep 2019 (actual)
Results: Posted 22 Jun 2022

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Diagnosis
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Non-Dry Eye	Experimental	Drug: Systane CompleteInstill eye drop and perform followup assessments on people with a Ocular Surface Disease Index score <13 and a non-invasive Keratograph break-up time of >/= 10 seconds in the worst eye
Dry Eye	Experimental	Drug: Systane CompleteInstill eye drop and perform followup assessments on people with an Ocular Surface Disease Index score >/= 13 and a non-invasive Keratograph break-up time </= 5 seconds in the worst eye

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (9 listed)

Is at least 18 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;
Is willing to be awake for at least 2 hours before visit 2;
Is willing not to wear eye makeup on the day of visit 2;

Key exclusion criteria (16 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
Systane CompleteSystane Complete will be instilled and rate of evaporation assessed before and after.	Drug	Dry Eye, Non-Dry Eye

Primary outcome

Tear Evaporation Rate
Time frame: Baseline (Prior to instillation); 10, 30 and 60 minutes post instillation of eye drop
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 right eye was analyzed.

Results and safety

Results posted to the registry on 22 Jun 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Non-Dry Eye	10	10
Dry Eye	11	10

Primary outcome: Tear Evaporation Rate

Time frame: Baseline (Prior to instillation); 10, 30 and 60 minutes post instillation of eye drop. Mean (Standard Deviation). Unit: % relative humidity per second

Measure	Non-Dry Eye n = 10	Dry Eye n = 10
Baseline	1.15 (0.19)	1.38 (0.22)
10 minutes post-drop	1.26 (0.31)	1.32 (0.25)
30 minutes post-drop	1.01 (0.24)	1.18 (0.27)
60 minutes post-drop	1.07 (0.31)	1.27 (0.27)

Non-Dry Eye: p = 0.002, ANOVA
Non-Dry Eye vs Dry Eye: p = 0.022, t-test, 2 sided

Population analysed: The analysis population includes all participants that were exposed to Systane Complete, and excludes the one dry eye subject that was lost to follow-up.

Adverse events

Time frame: Adverse events were collected from the time of consent for the duration of the study (up to 2 weeks). Adverse events are reported as pre-treatment or post-treatment.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Non-Dry Eye	0 of 10 (0%)	1 of 10 (10%)	1 of 10
Dry Eye	0 of 11 (0%)	2 of 11 (18.2%)	2 of 11

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Evaporative Dry Eye

Not yet recruitingPhase 4
Evaporative Dry Eye
Dry Eye, Evaporative Dry Eye
Active, not recruitingObservational study
Study for Remote Investigation of Evaporative Dry Eye Disease
Evaporative Loss Dry Eye Disease
Enrolling by invitation
Microbiome-Focused Food Supplement for Evaporative Dry Eye Due to Meibomian Gland Dysfunction
Dry Eye, Evaporative Dry Eye Disease
Active, not recruiting
Comparative Efficacy of Lipid Based Artificial Tears vs Aqueous Based Artificial Tears in Managing EDE
Evaporative Dry Eye
Not yet recruiting
Efficacy of Lipid-containing Artificial Tears in the Treatment of Dry Eye
Dry Eye Disease, Dry Eye

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.

Lyndon Jones, PhD, FCOptom principal investigator

Centre for Ocular Research & Education

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Systane Complete 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 9 inclusion and 16 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 22 Jun 2022. 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.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 22 Jun 2022). 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 (time frame: Baseline (Prior to instillation); 10, 30 and 60 minutes post instillation of eye drop). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04091581.

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 22 Jun 2022.