Dry Eye SyndromesNCT03274999

Clinical Study to Evaluate Tear Characteristics Following Acute TrueTear™ Use

A study testing TrueTear™ Application in people with Dry Eye Syndromes, run by Allergan at 1 site in United Kingdom.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Trial summary

This study will evaluate the change in tear meniscus height (TMH) produced by intranasal stimulation with TrueTear™ compared with the same device applied extranasally (control). 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?: TrueTear™ Application
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 10 participants
Where: 1 siteUnited Kingdom
Study dates: 18 Oct 2017to 9 Nov 2017
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 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Baseline Ocular Surface Disease Index© (OSDI©) score of at least 23 with no more than three responses of "not applicable"
In at least one eye, a baseline Schirmer test of ≤ 10 mm/5 minutes AND a cotton swab nasal stimulation Schirmer test of at least 7 mm higher in the same eye

Who cannot join

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
Intraocular and extraocular surgery in either eye within three months of the Screening Visit or refractive surgery within twelve months of 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.

United Kingdom1 site

Ocular Technology Group International
London, SW1E 6AU

Other trials in United Kingdom

About this study

Official title: Randomized, Controlled, Single-Center, Cross-Over Clinical Study to Evaluate Tear Characteristics Following Acute TrueTear™ Use

This study will evaluate the change in tear meniscus height (TMH) produced by intranasal stimulation with TrueTear™ compared with the same device applied extranasally (control).

Conditions: Dry Eye Syndromes
Being tested: TrueTear™ Application
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.

TrueTear™ ApplicationDevice
Intranasal and extranasal application of TrueTear™ device for approximately 3 minutes at Day 0 and Day 14.

Study groups in NCT03274999
Study group	Role	What they receive
TrueTear™ Intranasal then Extranasal Application	Experimental	TrueTear™ device, intranasal (test) application, for approximately 3 minutes on Day 0 followed by TrueTear™ device, extranasal (control) application, for approximately 3 minutes on Day 14. Receives: Device: TrueTear™ Application
TrueTear™ Extranasal then Intranasal Application	Experimental	TrueTear™ device, extranasal (control) application, for approximately 3 minutes on Day 0 followed by TrueTear™ device, intranasal (test) application, for approximately 3 minutes on Day 14. Receives: Device: TrueTear™ Application

What is being measured

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

Change From Baseline (Pre-application) in Tear Meniscus Height (TMH) at Eye Opening and Pre-Blink
Tear meniscus height is defined as the mean height of the lower tear prism to the edge of the eye lid measured by the investigator using the Tear scope Plus in conjunction with a Topcon SL-D7 slit lamp biomicroscope and high-resolution digital video recording. Change from Baseline to time (T) T0 (immediately), T15, T30, T60, T120, T180, T240, T300, T360 minutes (mins) after application was reported. A negative change from Baseline (Pre-application) indicates improvement.
Measured: Pre-application (Day 0) to time (T) 0 (immediately), 15, 30, 60, 120, 180, 240, 300 and 360 minutes on Day 0 after application
Change From Baseline (Pre-application) in Tear Lipid Layer Thickness at Eye Opening and Pre-Blink
Lipid layer thickness is defined as the average thickness of the lipid layer calculated from the thickness of the various pattern weighted by the relative coverage of each pattern measured by the investigator using the Tearscope Plus in conjunction with a Topcon SL-D7 slit lamp biomicroscope and high-resolution digital video recording. Change from Baseline to T0 (immediately), T15, T30, T60, T120, T180, T240, T300, T360 mins after application was reported. A negative change from Baseline (Pre-application) indicates improvement .
Measured: Pre-application (Day 0) to time (T) 0 (immediately), 15, 30, 60, 120, 180, 240, 300 and 360 minutes on Day 0 after application
Change From Baseline (Pre-application) in Non-Invasive Tear Film Break-Up Time (NIBUT)
Non-invasive break-up time is the time in seconds between eye opening and the appearance of the first visible break in the lipid layer of the pre-corneal tear film measured by the investigator using the Tearscope Plus in conjunction with a Topcon SL-D7 slit lamp biomicroscope and high-resolution digital video recording. Change from Baseline to T0 (immediately), T15, T30, T60, T120, T180, T240, T300, T360 mins after application was reported. A negative change from Baseline (Pre-application) indicates improvement.
Measured: Pre-application (Day 0) to time (T) 0 (immediately), 15, 30, 60, 120, 180, 240, 300 and 360 minutes on Day 0 after application
Change From Pre-application in Protective Index (PI)
The Protected Index (PI) corresponds to the percentage of the corneal surface that is not exposed to the atmosphere (i.e. fully covered by the tear film) over the full interblink period measured by the investigator using a Tear scope Plus in conjunction with a Topcon SL-D7 slit lamp biomicroscope and high-resolution digital video recording. Change from Baseline to T0 (immediately), T15, T30, T60, T120, T180, T240, T300, T360 mins after application was reported.
Measured: Pre-application (Day 0) to time (T) 0 (immediately), 15, 30, 60, 120, 180, 240, 300 and 360 minutes on Day 0 after application
Change From Pre-application in Exposed Area (EA)
Exposed Area is defined as the percentage of the observed area not covered by the tear film at the time of the blink hence exposed to the atmosphere measured by the investigator using a Tear scope Plus in conjunction with a Topcon SL-D7 slit lamp biomicroscope and high-resolution digital video recording. Change from Baseline to T0 (immediately), T15, T30, T60, T120, T180, T240, T300, T360 mins after application was reported.
Measured: Pre-application (Day 0) to time (T) 0 (immediately), 15, 30, 60, 120, 180, 240, 300 and 360 minutes on Day 0 after application

Timeline

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

18 Oct 20179 Nov 2017

First posted7 Sep 2017
Study start18 Oct 2017
Primary completion9 Nov 2017
Study completion9 Nov 2017

Why it stopped: Based on interim review and decision to re-design the study.

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: Crossover
Masking: None (open label)
Enrolment: 10 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03274999
Sponsor's protocol ID: OCUN-020
Status last verified: Mar 2021
First submitted: 5 Sep 2017
Last updated: 8 Mar 2021
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 8 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Randomized, Controlled, Single-Center, Cross-Over Clinical Study to Evaluate Tear Characteristics Following Acute TrueTear™ Use
ClinicalTrials.gov ID: NCT03274999
Acronym / sponsor ID: OCUN-020
Conditions: Dry Eye Syndromes
Study type: Interventional
Recruitment status: TerminatedReason stopped: Based on interim review and decision to re-design the study.
Enrolment: 10 participants (actual)
Lead sponsor: AllerganIndustry (pharma, biotech, devices)
Study start: 18 Oct 2017 (actual)
Primary completion: 9 Nov 2017 (actual)
Study completion: 9 Nov 2017 (actual)
First posted: 7 Sep 2017 (actual)
Results: Posted 8 Mar 2021

Clinical summary

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

This study will evaluate the change in tear meniscus height (TMH) produced by intranasal stimulation with TrueTear™ compared with the same device applied extranasally (control).

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
TrueTear™ Intranasal then Extranasal Application	Experimental	Device: TrueTear™ ApplicationTrueTear™ device, intranasal (test) application, for approximately 3 minutes on Day 0 followed by TrueTear™ device, extranasal (control) application, for approximately 3 minutes on Day 14.
TrueTear™ Extranasal then Intranasal Application	Experimental	Device: TrueTear™ ApplicationTrueTear™ device, extranasal (control) application, for approximately 3 minutes on Day 0 followed by TrueTear™ device, intranasal (test) application, for approximately 3 minutes on Day 14.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Baseline Ocular Surface Disease Index© (OSDI©) score of at least 23 with no more than three responses of "not applicable"
In at least one eye, a baseline Schirmer test of ≤ 10 mm/5 minutes AND a cotton swab nasal stimulation Schirmer test of at least 7 mm higher in the same eye

Key exclusion criteria (5 listed)

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
Intraocular and extraocular surgery in either eye within three months of the Screening Visit or refractive surgery within twelve months of 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
TrueTear™ ApplicationIntranasal and extranasal application of TrueTear™ device for approximately 3 minutes at Day 0 and Day 14.	Device	TrueTear™ Extranasal then Intranasal Application, TrueTear™ Intranasal then Extranasal Application

Primary outcome

Change From Baseline (Pre-application) in Tear Meniscus Height (TMH) at Eye Opening and Pre-Blink
Time frame: Pre-application (Day 0) to time (T) 0 (immediately), 15, 30, 60, 120, 180, 240, 300 and 360 minutes on Day 0 after application
Tear meniscus height is defined as the mean height of the lower tear prism to the edge of the eye lid measured by the investigator using the Tear scope Plus in conjunction with a Topcon SL-D7 slit lamp biomicroscope and high-resolution digital video recording. Change from Baseline to time (T) T0 (immediately), T15, T30, T60, T120, T180, T240, T300, T360 minutes (mins) after application was reported. A negative change from Baseline (Pre-application) indicates improvement.
Change From Baseline (Pre-application) in Tear Lipid Layer Thickness at Eye Opening and Pre-Blink
Time frame: Pre-application (Day 0) to time (T) 0 (immediately), 15, 30, 60, 120, 180, 240, 300 and 360 minutes on Day 0 after application
Lipid layer thickness is defined as the average thickness of the lipid layer calculated from the thickness of the various pattern weighted by the relative coverage of each pattern measured by the investigator using the Tearscope Plus in conjunction with a Topcon SL-D7 slit lamp biomicroscope and high-resolution digital video recording. Change from Baseline to T0 (immediately), T15, T30, T60, T120, T180, T240, T300, T360 mins after application was reported. A negative change from Baseline (Pre-application) indicates improvement .
Change From Baseline (Pre-application) in Non-Invasive Tear Film Break-Up Time (NIBUT)
Time frame: Pre-application (Day 0) to time (T) 0 (immediately), 15, 30, 60, 120, 180, 240, 300 and 360 minutes on Day 0 after application
Non-invasive break-up time is the time in seconds between eye opening and the appearance of the first visible break in the lipid layer of the pre-corneal tear film measured by the investigator using the Tearscope Plus in conjunction with a Topcon SL-D7 slit lamp biomicroscope and high-resolution digital video recording. Change from Baseline to T0 (immediately), T15, T30, T60, T120, T180, T240, T300, T360 mins after application was reported. A negative change from Baseline (Pre-application) indicates improvement.
Change From Pre-application in Protective Index (PI)
Time frame: Pre-application (Day 0) to time (T) 0 (immediately), 15, 30, 60, 120, 180, 240, 300 and 360 minutes on Day 0 after application
The Protected Index (PI) corresponds to the percentage of the corneal surface that is not exposed to the atmosphere (i.e. fully covered by the tear film) over the full interblink period measured by the investigator using a Tear scope Plus in conjunction with a Topcon SL-D7 slit lamp biomicroscope and high-resolution digital video recording. Change from Baseline to T0 (immediately), T15, T30, T60, T120, T180, T240, T300, T360 mins after application was reported.
Change From Pre-application in Exposed Area (EA)
Time frame: Pre-application (Day 0) to time (T) 0 (immediately), 15, 30, 60, 120, 180, 240, 300 and 360 minutes on Day 0 after application
Exposed Area is defined as the percentage of the observed area not covered by the tear film at the time of the blink hence exposed to the atmosphere measured by the investigator using a Tear scope Plus in conjunction with a Topcon SL-D7 slit lamp biomicroscope and high-resolution digital video recording. Change from Baseline to T0 (immediately), T15, T30, T60, T120, T180, T240, T300, T360 mins after application was reported.

Results and safety

Results posted to the registry on 8 Mar 2021, 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™ Intranasal Then Extranasal Application	5	5
TrueTear™ Extranasal Then Intranasal Application	5	5

Primary outcome: Change From Baseline (Pre-application) in Tear Meniscus Height (TMH) at Eye Opening and Pre-Blink

Time frame: Pre-application (Day 0) to time (T) 0 (immediately), 15, 30, 60, 120, 180, 240, 300 and 360 minutes on Day 0 after application. Mean (Standard Deviation). Unit: mm

Measure	TrueTear™ Extranasal Application n = 10	TrueTear™ Intranasal Application n = 10
Eye-opening,Pre-application,Day 0	0.312 (0.132)	0.310 (0.143)
Eye-opening,Change at T0 after application,Day 0	0.047 (0.205)	0.105 (0.177)
Eye-opening,Change at T15 after application,Day 0	0.010 (0.110)	0.002 (0.096)
Eye-opening,Change at T30 after application,Day 0	-0.035 (0.118)	-0.003 (0.100)
Eye-opening,Change at T60 after application,Day 0	-0.018 (0.107)	-0.038 (0.092)
Eye-opening,Change at T120 after application,Day 0	-0.021 (0.138)	-0.039 (0.101)
Eye-opening,Change at T180 after application,Day 0	-0.049 (0.136)	-0.032 (0.103)
Eye-opening,Change at T240 after application,Day 0	-0.022 (0.125)	-0.033 (0.137)

TrueTear™ Extranasal Application vs TrueTear™ Intranasal Application: p = 0.156, t-test, 1 sided
TrueTear™ Extranasal Application vs TrueTear™ Intranasal Application: p = 0.395, t-test, 1 sided
TrueTear™ Extranasal Application vs TrueTear™ Intranasal Application: p = 0.114, t-test, 1 sided

Population analysed: All participants who met the eligibility criteria, adhered to the protocol, and successfully completed the full study assessment were included in the per-protocol analysis.

Primary outcome: Change From Baseline (Pre-application) in Tear Lipid Layer Thickness at Eye Opening and Pre-Blink

Time frame: Pre-application (Day 0) to time (T) 0 (immediately), 15, 30, 60, 120, 180, 240, 300 and 360 minutes on Day 0 after application. Mean (Standard Deviation). Unit: nm

Measure	TrueTear™ Extranasal Application n = 10	TrueTear™ Intranasal Application n = 10
Eye-opening,Pre-application,Day 0	41.090 (12.185)	33.541 (9.848)
Eye-opening,Change at T0 after application,Day 0	0.325 (19.890)	25.255 (21.278)
Eye-opening,Change at T15 after application,Day 0	-2.527 (16.680)	6.154 (9.924)
Eye-opening,Change at T30 after application,Day 0	-6.820 (14.292)	6.944 (14.559)
Eye-opening,Change at T60 after application,Day 0	-2.542 (17.665)	6.174 (13.224)
Eye-opening,Change at T120 after application,Day 0	-6.385 (16.423)	-0.310 (11.519)
Eye-opening,Change at T180 after application,Day 0	-2.766 (12.617)	1.522 (9.387)
Eye-opening,Change at T240 after application,Day 0	-4.815 (16.918)	2.212 (9.965)

TrueTear™ Extranasal Application vs TrueTear™ Intranasal Application: p = 0.006, t-test, 1 sided
TrueTear™ Extranasal Application vs TrueTear™ Intranasal Application: p = 0.063, t-test, 1 sided
TrueTear™ Extranasal Application vs TrueTear™ Intranasal Application: p = 0.005, t-test, 1 sided

Population analysed: All participants who met the eligibility criteria, adhered to the protocol, and successfully completed the full study assessment were included in the per-protocol analysis.

Primary outcome: Change From Baseline (Pre-application) in Non-Invasive Tear Film Break-Up Time (NIBUT)

Time frame: Pre-application (Day 0) to time (T) 0 (immediately), 15, 30, 60, 120, 180, 240, 300 and 360 minutes on Day 0 after application. Mean (Standard Deviation). Unit: seconds

Measure	TrueTear™ Extranasal Application n = 10	TrueTear™ Intranasal Application n = 10
Pre-application, Day 0	18.211 (23.626)	10.536 (8.458)
Change at T0 after application, Day 0	-2.668 (16.857)	4.784 (13.738)
Change at T15 after application, Day 0	-2.489 (15.788)	0.835 (8.258)
Change at T30 after application, Day 0	3.561 (19.045)	-0.639 (7.272)
Change at T60 after application, Day 0	6.951 (27.848)	-0.954 (9.171)
Change at T120 after application, Day 0	-0.128 (14.178)	1.683 (7.172)
Change at T180 after application, Day 0	4.911 (20.700)	-0.449 (6.029)
Change at T240 after application, Day 0	1.525 (26.612)	-0.787 (9.026)

TrueTear™ Extranasal Application vs TrueTear™ Intranasal Application: p = 0.053, t-test, 1 sided
TrueTear™ Extranasal Application vs TrueTear™ Intranasal Application: p = 0.206, t-test, 1 sided
TrueTear™ Extranasal Application vs TrueTear™ Intranasal Application: p = 0.221, t-test, 1 sided

Population analysed: All participants who met the eligibility criteria, adhered to the protocol, and successfully completed the full study assessment were included in the per-protocol analysis.

Primary outcome: Change From Pre-application in Protective Index (PI)

Time frame: Pre-application (Day 0) to time (T) 0 (immediately), 15, 30, 60, 120, 180, 240, 300 and 360 minutes on Day 0 after application. Mean (Standard Deviation). Unit: percentage of area covered by tear film

Measure	TrueTear™ Extranasal Application n = 10	TrueTear™ Intranasal Application n = 10
Pre-application, Day 0	99.999 (0.004)	98.797 (5.351)
Change at T0 after application, Day 0	-0.003 (0.015)	1.200 (5.343)
Change at T15 after application, Day 0	0.000 (0.001)	1.198 (5.352)
Change at T30 after application, Day 0	-0.009 (0.036)	1.196 (5.352)
Change at T60 after application, Day 0	0.000 (0.007)	1.196 (5.352)
Change at T120 after application, Day 0	0.000 (0.002)	1.179 (5.260)
Change at T180 after application, Day 0	0.001 (0.004)	1.193 (5.353)
Change at T240 after application, Day 0	-0.005 (0.020)	1.196 (5.352)

TrueTear™ Extranasal Application vs TrueTear™ Intranasal Application: p = 0.034, t-test, 1 sided
TrueTear™ Extranasal Application vs TrueTear™ Intranasal Application: p = 0.143, t-test, 1 sided
TrueTear™ Extranasal Application vs TrueTear™ Intranasal Application: p = 0.328, t-test, 1 sided

Population analysed: All participants who met the eligibility criteria, adhered to the protocol, and successfully completed the full study assessment were included in the per-protocol analysis.

Adverse events

Time frame: Day 0 up to Day 14. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
TrueTear™ Extranasal Application	0 of 10 (0%)	0 of 10 (0%)	0 of 10
TrueTear™ Intranasal Application	0 of 10 (0%)	0 of 10 (0%)	0 of 10

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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.

Clinical Director study director

Allergan, plc

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™ Application in people with Dry Eye Syndromes, run by Allergan at 1 site in United Kingdom.

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 2 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: stopped early, as of the sponsor's last update on 8 Mar 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 United Kingdom. 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 8 Mar 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?

Change From Baseline (Pre-application) in Tear Meniscus Height (TMH) at Eye Opening and Pre-Blink (time frame: Pre-application (Day 0) to time (T) 0 (immediately), 15, 30, 60, 120, 180, 240, 300 and 360 minutes on Day 0 after application). The study lists 5 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 NCT03274999.

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 8 Mar 2021.