Dry Eye SyndromesNCT03325673

Clinical Trial to Evaluate the Symptoms in Symptomatic Contact Lens Wearers Following Application of Intranasal Tear Neurostimulator Versus Control

A study testing TrueTear in people with Dry Eye Syndromes, run by Allergan at 1 site in Canada.

Completed

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

Trial summary

This study will evaluate the increase in comfort and comfortable contact lens (CL) wear time associated with application of TrueTear (active intranasal neurostimulation) compared with application of TrueTear sham control (intranasal application which is not electrically active) in symptomatic CL wearers. Read more about this study

Who is it for?: Ages 22 years and older
Conditions the study is for: Dry Eye Syndromes
What is being tested?: TrueTear
Type of treatment: Medical device
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 84 participants
Where: 1 siteCanada
Study dates: 22 Nov 2017to 29 Nov 2018
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 22 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

A person is eligible for inclusion if he/she
In at least one eye, has a cotton swab nasal stimulation Schirmer test score at least 4 mm greater than 3 minute Schirmer with anesthesia basal score in the same eye at the Screening Visit
Is an adapted soft contact lens wearer and currently wears lenses an average of at least 2 days per week, with an average minimum wearing time of 3 hours each day over the past month and is able and willing to wear lenses for at least 6 hours on four study day visits
Has at least 20/40 visual acuity in both eyes with CL correction
Is symptomatic according to Young's categorization

Who cannot join

Refractive error surgery
Chronic or recurrent epistaxis, coagulation disorders or other conditions that may increase the risk of bleeding
History of nasal or sinus surgery
Vascularized polyp, deviated septum or severe nasal airway obstruction at the Screening visit
Cardiac demand pacemaker, implanted defibrillator, or other active implanted metallic or active implanted electronic device in the head

Trial locations and contacts

1 site in 1 country.

Canada1 site

Centre for Contact Lens Research School of Optometry & Vision Science, University of Waterloo
Waterloo, Ontario, N2L 3G1

Other trials in Canada

About this study

Official title: Randomized, Double-arm, Controlled Clinical Trial to Evaluate the Symptoms in Symptomatic Contact Lens Wearers Following Application of Intranasal Tear Neurostimulator Versus Control (CORIANDER)

Conditions: Dry Eye Syndromes
Being tested: TrueTear, TrueTear Sham Control
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.

TrueTearDevice
TrueTear Device (Intranasal Tear Neurostimulator) was used intranasally on CL wear days; it was also used on non-CL wear days if the participant chose. The number of applications was determined by participant.
TrueTear Sham ControlDevice
TrueTear sham device, which is not electrically active and has limited tip insertion depth, was used intranasally on CL wear days; it was also used on non-CL wear days if participant chose. The number of applications was determined by participant.

Study groups in NCT03325673
Study group	Role	What they receive
TrueTear	Experimental	TrueTear Device (Intranasal Tear Neurostimulator) was used intranasally on contact lens (CL) wear days; it was also used on non-CL wear days if the participant chose. The number of applications was determined by participant. Receives: Device: TrueTear
TrueTear Sham Control	Sham comparator	TrueTear sham device, which is not electrically active and has limited tip insertion depth, was used intranasally on CL wear days; it was also used on non-CL wear days if participant chose. The number of applications was determined by participant. Receives: Device: TrueTear Sham Control

What is being measured

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

Contact Lens Dry Eye Questionnaire (CLDEQ-8) Score in the Study Eye
The CLDEQ-8 is a validated questionnaire used to quantify symptoms experienced by the contact lenses (CLs) wearer. The participants were asked to respond to 8 questions about how their CLs performed over the preceding 2-week period. 4 questions (Eye discomfort, Eye dryness, Changeable blurry vision and Closing your eyes) answered on a scale of 0=Never to 4=Constantly; 3 questions about the end of wearing time (Discomfort, Dryness, Changeable blurry vision) answered on a scale of 0=Never have it to 5=Very Intense and 1 question (Removing your lenses) on a scale of 1=Never to 6=Several times a day for a total possible score of 1(best) to 37 (worst). The study eye was defined as the qualified eye with the greatest increase in tear production with stimulation by a cotton swab at the Screening Visit. If both eyes qualified, then the right eye was designated as the study eye.
Measured: Day 28
Comfort Rating Score in the Study Eye
The participant assessed contact lens comfort in the study eye using a 100 point scale where a score of 0=Extremely uncomfortable and a score of 100=Extremely comfortable. The study eye was defined as the qualified eye with the greatest increase in tear production with stimulation by a cotton swab at the Screening Visit. If both eyes qualified, then the right eye was designated as the study eye.
Measured: CL Insertion, After 2 hours and the End of Day on Day 24
Comfortable Wear Time (CWT) in the Study Eye
CWT was calculated by taking the difference between the time participants reported started to find their CLs getting uncomfortable and the reported insertion time for that day. The study eye was defined as the qualified eye with the greatest increase in tear production with stimulation by a cotton swab at the Screening Visit. If both eyes qualified, then the right eye was designated as the study eye.
Measured: Day 24
Total Wear Time (Total WT) in the Study Eye
Total WT was calculated by taking the difference between the time participants reported removing their CLs and the reported insertion time for that day. The study eye was defined as the qualified eye with the greatest increase in tear production with stimulation by a cotton swab at the Screening Visit. If both eyes qualified, then the right eye was designated as the study eye.
Measured: Day 24

Timeline

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

22 Nov 201729 Nov 2018

First posted30 Oct 2017
Study start22 Nov 2017
Primary completion29 Nov 2018
Study completion29 Nov 2018

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 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: Parallel groups
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 84 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03325673
Sponsor's protocol ID: OCUN-024
Status last verified: Dec 2019
First submitted: 3 Oct 2017
Last updated: 18 Dec 2019
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: No
FDA-regulated device: Yes

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

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All Dry Eye Syndromes trials

Study at a glance

From the registry record, last updated by the sponsor on 18 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Randomized, Double-arm, Controlled Clinical Trial to Evaluate the Symptoms in Symptomatic Contact Lens Wearers Following Application of Intranasal Tear Neurostimulator Versus Control (CORIANDER)
ClinicalTrials.gov ID: NCT03325673
Acronym / sponsor ID: OCUN-024
Conditions: Dry Eye Syndromes
Study type: Interventional
Recruitment status: Completed
Enrolment: 84 participants (actual)
Lead sponsor: AllerganIndustry (pharma, biotech, devices)
Study start: 22 Nov 2017 (actual)
Primary completion: 29 Nov 2018 (actual)
Study completion: 29 Nov 2018 (actual)
First posted: 30 Oct 2017 (actual)
Results: Posted 6 Dec 2019

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: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
TrueTear	Experimental	Device: TrueTearTrueTear Device (Intranasal Tear Neurostimulator) was used intranasally on contact lens (CL) wear days; it was also used on non-CL wear days if the participant chose. The number of applications was determined by participant.
TrueTear Sham Control	Sham comparator	Device: TrueTear Sham ControlTrueTear sham device, which is not electrically active and has limited tip insertion depth, was used intranasally on CL wear days; it was also used on non-CL wear days if participant chose. The number of applications was determined by participant.

Who may qualify

Ages: 22 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

A person is eligible for inclusion if he/she
In at least one eye, has a cotton swab nasal stimulation Schirmer test score at least 4 mm greater than 3 minute Schirmer with anesthesia basal score in the same eye at the Screening Visit
Is an adapted soft contact lens wearer and currently wears lenses an average of at least 2 days per week, with an average minimum wearing time of 3 hours each day over the past month and is able and willing to wear lenses for at least 6 hours on four study day visits
Has at least 20/40 visual acuity in both eyes with CL correction
Is symptomatic according to Young's categorization

Key exclusion criteria (5 listed)

Refractive error surgery
Chronic or recurrent epistaxis, coagulation disorders or other conditions that may increase the risk of bleeding
History of nasal or sinus surgery
Vascularized polyp, deviated septum or severe nasal airway obstruction at the Screening visit
Cardiac demand pacemaker, implanted defibrillator, or other active implanted metallic or active implanted electronic device in the head

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
TrueTearTrueTear Device (Intranasal Tear Neurostimulator) was used intranasally on CL wear days; it was also used on non-CL wear days if the participant chose. The number of applications was determined by participant.	Device	TrueTear
TrueTear Sham ControlTrueTear sham device, which is not electrically active and has limited tip insertion depth, was used intranasally on CL wear days; it was also used on non-CL wear days if participant chose. The number of applications was determined by participant.	Device	TrueTear Sham Control

Primary outcome

Contact Lens Dry Eye Questionnaire (CLDEQ-8) Score in the Study Eye
Time frame: Day 28
The CLDEQ-8 is a validated questionnaire used to quantify symptoms experienced by the contact lenses (CLs) wearer. The participants were asked to respond to 8 questions about how their CLs performed over the preceding 2-week period. 4 questions (Eye discomfort, Eye dryness, Changeable blurry vision and Closing your eyes) answered on a scale of 0=Never to 4=Constantly; 3 questions about the end of wearing time (Discomfort, Dryness, Changeable blurry vision) answered on a scale of 0=Never have it to 5=Very Intense and 1 question (Removing your lenses) on a scale of 1=Never to 6=Several times a day for a total possible score of 1(best) to 37 (worst). The study eye was defined as the qualified eye with the greatest increase in tear production with stimulation by a cotton swab at the Screening Visit. If both eyes qualified, then the right eye was designated as the study eye.
Comfort Rating Score in the Study Eye
Time frame: CL Insertion, After 2 hours and the End of Day on Day 24
The participant assessed contact lens comfort in the study eye using a 100 point scale where a score of 0=Extremely uncomfortable and a score of 100=Extremely comfortable. The study eye was defined as the qualified eye with the greatest increase in tear production with stimulation by a cotton swab at the Screening Visit. If both eyes qualified, then the right eye was designated as the study eye.
Comfortable Wear Time (CWT) in the Study Eye
Time frame: Day 24
CWT was calculated by taking the difference between the time participants reported started to find their CLs getting uncomfortable and the reported insertion time for that day. The study eye was defined as the qualified eye with the greatest increase in tear production with stimulation by a cotton swab at the Screening Visit. If both eyes qualified, then the right eye was designated as the study eye.
Total Wear Time (Total WT) in the Study Eye
Time frame: Day 24
Total WT was calculated by taking the difference between the time participants reported removing their CLs and the reported insertion time for that day. The study eye was defined as the qualified eye with the greatest increase in tear production with stimulation by a cotton swab at the Screening Visit. If both eyes qualified, then the right eye was designated as the study eye.

Results and safety

Results posted to the registry on 6 Dec 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
TrueTear	42	38
TrueTear Sham Control	42	42

Primary outcome: Contact Lens Dry Eye Questionnaire (CLDEQ-8) Score in the Study Eye

Time frame: Day 28. Mean (Standard Deviation). Unit: score on a scale

Measure	TrueTear n = 38	TrueTear Sham Control n = 40
Value	15.3 (5.6)	17.2 (5.2)

TrueTear vs TrueTear Sham Control: p = 0.116, Independent t-test

Population analysed: All eligible participants with data available for analysis at the given time-point.

Primary outcome: Comfort Rating Score in the Study Eye

Time frame: CL Insertion, After 2 hours and the End of Day on Day 24. Mean (Standard Deviation). Unit: score on a scale

Measure	TrueTear n = 38	TrueTear Sham Control n = 40
Insertion	88 (11)	86 (16)
After 2 hours	86 (11)	82 (17)
End of Day 24	75 (17)	69 (19)

TrueTear vs TrueTear Sham Control: p = 0.468, t-test, 2 sided
TrueTear vs TrueTear Sham Control: p = 0.235, t-test, 2 sided
TrueTear vs TrueTear Sham Control: p = 0.152, t-test, 2 sided

Population analysed: All eligible participants with data available for analysis at the given time-point.

Primary outcome: Comfortable Wear Time (CWT) in the Study Eye

Time frame: Day 24. Mean (Standard Deviation). Unit: minutes

Measure	TrueTear n = 34	TrueTear Sham Control n = 36
Value	618 (272)	574 (254)

TrueTear vs TrueTear Sham Control: p = 0.488, t-test, 2 sided

Population analysed: All eligible participants with data available for analysis at the given time-point.

Primary outcome: Total Wear Time (Total WT) in the Study Eye

Time frame: Day 24. Mean (Standard Deviation). Unit: minutes

Measure	TrueTear n = 34	TrueTear Sham Control n = 36
Value	747 (201)	652 (233)

TrueTear vs TrueTear Sham Control: p = 0.072, t-test, 2 sided

Population analysed: All eligible participants with data available for analysis at the given time-point.

Adverse events

Time frame: Day 0 to Day 28 +/- 3 days. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
TrueTear	0 of 42 (0%)	3 of 42 (7.1%)	0 of 42
TrueTear Sham Control	0 of 42 (0%)	4 of 42 (9.5%)	0 of 42

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Dry Eye Syndromes

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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.

Michelle Senchyna study chair

Allergan

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

Questions about this trial

What is this clinical trial studying?

A study testing TrueTear in people with Dry Eye Syndromes, run by Allergan 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 5 inclusion and 5 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 Dec 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 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. Some participants in this study may receive a placebo. 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 6 Dec 2019). 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?

Contact Lens Dry Eye Questionnaire (CLDEQ-8) Score in the Study Eye (time frame: Day 28). The study lists 4 primary outcomes in all. 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 NCT03325673.

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 Dec 2019.