Dry Eye SyndromesPhase 4IMPACTNCT02121847

Investigation of Maintaining Visual Performance Achieved With Cyclosporine Therapy

A Phase 4 study testing cyclosporine 0.05% ophthalmic emulsion and carboxymethylcellulose-based lubricant eye drops in people with Dry Eye Syndromes, run by Allergan at 1 site in United States.

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

This study will evaluate the safety and efficacy of cyclosporine 0.05% ophthalmic emulsion (Restasis®) in patients with dry eye disease. 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?: cyclosporine 0.05% ophthalmic emulsion and carboxymethylcellulose-based lubricant eye drops
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 40 participants
Where: 1 siteUnited States
Study dates: 3 Apr 2014to 23 Sep 2014
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
No healthy volunteers
Adult, Older adult

Who may be able to join

History of dry eye in both eyes
Willing to use eye drops for dry eye symptoms

Who cannot join

Anticipate wearing contact lenses during the study
Laser-assisted in situ keratomileusis (LASIK) surgery within the past 12 months
Any ocular and/or lid surgeries within the past 6 months
Cataract surgery in either eye
Current or anticipated use of temporary punctal plugs during the study

Trial locations and contacts

1 site in 1 country.

United States1 site

Study site
Andover, Massachusetts

Other trials in United States

About this study

This study will evaluate the safety and efficacy of cyclosporine 0.05% ophthalmic emulsion (Restasis®) in patients with dry eye disease.

Conditions: Dry Eye Syndromes
Being tested: cyclosporine 0.05% ophthalmic emulsion, carboxymethylcellulose-based lubricant eye drops
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.

cyclosporine 0.05% ophthalmic emulsionDrug
Also called Restasis®
Cyclosporine 0.05% ophthalmic emulsion (Restasis®) eye drops administered twice daily for 6 months.
carboxymethylcellulose-based lubricant eye dropsDrug
Also called Refresh OPTIVE® Advanced
Carboxymethylcellulose-based lubricant eye drops (Refresh OPTIVE® Advanced) administered as needed for 6 months.

Study groups in NCT02121847
Study group	Role	What they receive
cyclosporine 0.05% ophthalmic emulsion	Experimental	Cyclosporine 0.05% ophthalmic emulsion (Restasis®) eye drops administered twice daily and carboxymethylcellulose-based lubricant eye drops (Refresh OPTIVE® Advanced) administered as needed for 6 months. Receives: Drug: cyclosporine 0.05% ophthalmic emulsion; Drug: carboxymethylcellulose-based lubricant eye drops

What is being measured

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

Change From Baseline in Total Corneal Staining Score With Fluorescein in the Worse Eye
Total corneal staining with fluorescein is measured in the worse eye utilizing the Ora CalibraTM Corneal Flourescein Staining Scale (0 to 4 scale where 0=no staining and 4= severe staining). The sum of the total includes 3 regions of the cornea, resulting in a maximum possible score of 12 (severe staining score of 4 in all three regions). A negative change from baseline represents a decrease in staining (improvement). A positive change from baseline represents an increase in staining (worsening).
Measured: Baseline, Month 6
Change From Baseline in Total Conjunctival Staining Score With Fluorescein in the Worse Eye
Total conjunctival staining with fluorescein is measured in the worse eye utilizing the Ora CalibraTM Conjunctiva Flourescein Staining Scale (0 to 4 scale where 0=no staining and 4= severe staining). The sum of the total includes 2 regions of the conjunctiva, resulting in a maximum possible score of 8 (severe staining score of 4 in both regions). A negative change from baseline represents a decrease in staining (improvement). A positive change from baseline represents an increase in staining (worsening).
Measured: Baseline, Month 6
Change From Baseline in Total Corneal Staining Score With Lissamine Green in the Worse Eye
Total corneal staining with lissamine green is measured in the worse eye utilizing the Ora CalibraTM Corneal Lissamine Staining Scale (0 to 4 scale where 0=no staining and 4= severe staining). The sum of the total includes 3 regions of the cornea, resulting in a maximum possible score of 12 (severe staining score of 4 in all three regions). A negative change from baseline represents a decrease in staining (improvement). A positive change from baseline represents an increase in staining (worsening).
Measured: Baseline, Month 6
Change From Baseline in Total Conjunctival Staining Score With Lissamine Green in the Worse Eye
Total conjunctival staining with lissamine is measured in the worse eye utilizing the Ora CalibraTM Conjunctiva Lissamine Staining Scale (0 to 4 scale where 0=no staining and 4= severe staining). The sum of the total includes 2 regions of the conjunctiva, resulting in a maximum possible score of 8 (severe staining score of 4 in both regions). A negative change from baseline represents a decrease in staining (improvement). A positive change from baseline represents an increase in staining (worsening).
Measured: Baseline, Month 6
Change From Baseline in Reading on the Ocular Surface Disease Index (OSDI)
The OSDI consists of 12 questions measuring the presence of ocular symptoms. The reading question is assessed using a 5-point scale (0=none of the time; 4=all of the time). The reading score is converted to a 0-100 score where 0 is best and 100 is worst. Higher OSDI reading scores are associated with greater severity. A negative number change from baseline indicates improvement and a positive number change from baseline indicates worsening.
Measured: Baseline, Month 6
Change From Baseline in Driving at Night on the OSDI
The OSDI consists of 12 questions measuring the presence of ocular symptoms. The driving at night question is assessed using a 5-point scale (0=none of the time; 4=all of the time). The driving at night score is converted to a 0-100 score where 0 is best and 100 is worst. Higher OSDI reading scores are associated with greater severity. A negative number change from baseline indicates improvement and a positive number change from baseline indicates worsening.
Measured: Baseline, Month 6
Change From Baseline in Working With a Computer or Bank Machine on the OSDI
The OSDI consists of 12 questions measuring the presence of ocular symptoms. The working with a computer or bank machine question is assessed using a 5-point scale (0=none of the time; 4=all of the time). The working with a computer or bank machine score is converted to a 0-100 score where 0 is best and 100 is worst. Higher OSDI reading scores are associated with greater severity. A negative number change from baseline indicates improvement and a positive number change from baseline indicates worsening.
Measured: Baseline, Month 6
Change From Baseline in Watching TV on the OSDI
The OSDI consists of 12 questions measuring the presence of ocular symptoms. The watching TV question is assessed using a 5-point scale (0=none of the time; 4=all of the time). The watching TV score is converted to a 0-100 score where 0 is best and 100 is worst. Higher OSDI reading scores are associated with greater severity. A negative number change from baseline indicates improvement and a positive number change from baseline indicates worsening.
Measured: Baseline, Month 6
Change From Baseline in Reading Rate
Reading speed is assessed as the number of words read correctly in 2 minutes.
Measured: Baseline, Month 6
Change From Baseline in Words Read Incorrectly
The numbers of words read incorrectly are counted in 2 minutes. A positive change from baseline indicates a worsening, and a negative change from baseline indicates an improvement.
Measured: Baseline, Month 6
Change From Baseline in Font Size
The minimum font (letter) size read correctly is assessed. Smaller font size indicates better ability. A negative change from baseline indicates an improvement and a positive change from baseline indicates a worsening.
Measured: Baseline, Month 6

Secondary outcomes (5)

Change From Baseline in OSDI
The OSDI consists of 12 questions measuring the presence of ocular symptoms. Each of the 12 questions is assessed using a 5-point scale (0=none of the time; 4=all of the time). The score is converted to a 0-100 score where 0 is best and 100 is worst. Higher OSDI scores are associated with greater severity. A negative number change from baseline indicates improvement and a positive number change from baseline indicates worsening.
Measured: Baseline, Month 6
Change From Baseline in Ocular Discomfort on a 4-point Scale
Ocular discomfort is assessed on a 4-point scale where 0=no discomfort and 3=most discomfort. A positive number change from baseline indicates a worsening and a negative number change from baseline indicates an improvement.
Measured: Baseline, Month 6
Change From Baseline in Tear Film Break-up Time in the Worse Eye
TFBUT is defined as the time required for dry spots to appear on the surface of the eye after blinking. The longer it takes, the more stable the tear film. A positive number change from baseline indicates improvement and a negative number change from baseline indicates a worsening.
Measured: Baseline, Month 6
Change From Baseline in the Interblink Interval in the Worse Eye
The interblink interval measures the time (seconds) between blinks in the worse eye. A positive number change from baseline indicates a worsening (more frequent blinks) and a negative number change from baseline (less frequent blinks) indicates an improvement.
Measured: Baseline, Month 6
Change From Baseline in Conjunctival Redness in the Worse Eye
Conjunctival redness is scored in the worse eye on a numeric analog scale ranging from 0=None to 4=Extremely Severe (0.5 increments were allowed). A positive number change from baseline indicates a worsening and a negative number change from baseline indicates an improvement.
Measured: Baseline, Month 6

Timeline

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

3 Apr 201423 Sep 2014

First posted24 Apr 2014 (estimated)
Study start3 Apr 2014
Primary completion23 Sep 2014
Study completion23 Sep 2014

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.
Publications (1)Papers the sponsor has linked to this study.
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 4
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 40 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02121847
Sponsor's protocol ID: GMA-RES-014-001
Acronym: IMPACT
Status last verified: Apr 2019
First submitted: 22 Apr 2014
Last updated: 18 Apr 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Stonecipher KG, Torkildsen GL, Ousler GW 3rd, Morris S, Villanueva L, Hollander DA. The IMPACT study: a prospective evaluation of the effects of cyclosporine ophthalmic emulsion 0.05% on ocular surface staining and visual performance in patients with dry eye. Clin Ophthalmol. 2016 May 13;10:887-95. doi: 10.2147/OPTH.S101627. eCollection 2016.
PubMed 27257373

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?

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All Dry Eye Syndromes trials

Study at a glance

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

Official title: Investigation of Maintaining Visual Performance Achieved With Cyclosporine Therapy
ClinicalTrials.gov ID: NCT02121847
Acronym / sponsor ID: IMPACT / GMA-RES-014-001
Conditions: Dry Eye Syndromes
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 40 participants (actual)
Lead sponsor: AllerganIndustry (pharma, biotech, devices)
Study start: 3 Apr 2014 (actual)
Primary completion: 23 Sep 2014 (actual)
Study completion: 23 Sep 2014 (actual)
First posted: 24 Apr 2014 (estimated)
Results: Posted 25 Apr 2016

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 safety and efficacy of cyclosporine 0.05% ophthalmic emulsion (Restasis®) in patients with dry eye disease.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
cyclosporine 0.05% ophthalmic emulsion	Experimental	Drug: cyclosporine 0.05% ophthalmic emulsion, Drug: carboxymethylcellulose-based lubricant eye dropsCyclosporine 0.05% ophthalmic emulsion (Restasis®) eye drops administered twice daily and carboxymethylcellulose-based lubricant eye drops (Refresh OPTIVE® Advanced) administered as needed for 6 months.

Who may qualify

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

Key inclusion criteria (2 listed)

History of dry eye in both eyes
Willing to use eye drops for dry eye symptoms

Key exclusion criteria (5 listed)

Anticipate wearing contact lenses during the study
Laser-assisted in situ keratomileusis (LASIK) surgery within the past 12 months
Any ocular and/or lid surgeries within the past 6 months
Cataract surgery in either eye
Current or anticipated use of temporary punctal plugs during the study

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
cyclosporine 0.05% ophthalmic emulsionAlso: Restasis®Cyclosporine 0.05% ophthalmic emulsion (Restasis®) eye drops administered twice daily for 6 months.	Drug	cyclosporine 0.05% ophthalmic emulsion
carboxymethylcellulose-based lubricant eye dropsAlso: Refresh OPTIVE® AdvancedCarboxymethylcellulose-based lubricant eye drops (Refresh OPTIVE® Advanced) administered as needed for 6 months.	Drug	cyclosporine 0.05% ophthalmic emulsion

Primary outcome

Change From Baseline in Total Corneal Staining Score With Fluorescein in the Worse Eye
Time frame: Baseline, Month 6
Total corneal staining with fluorescein is measured in the worse eye utilizing the Ora CalibraTM Corneal Flourescein Staining Scale (0 to 4 scale where 0=no staining and 4= severe staining). The sum of the total includes 3 regions of the cornea, resulting in a maximum possible score of 12 (severe staining score of 4 in all three regions). A negative change from baseline represents a decrease in staining (improvement). A positive change from baseline represents an increase in staining (worsening).
Change From Baseline in Total Conjunctival Staining Score With Fluorescein in the Worse Eye
Time frame: Baseline, Month 6
Total conjunctival staining with fluorescein is measured in the worse eye utilizing the Ora CalibraTM Conjunctiva Flourescein Staining Scale (0 to 4 scale where 0=no staining and 4= severe staining). The sum of the total includes 2 regions of the conjunctiva, resulting in a maximum possible score of 8 (severe staining score of 4 in both regions). A negative change from baseline represents a decrease in staining (improvement). A positive change from baseline represents an increase in staining (worsening).
Change From Baseline in Total Corneal Staining Score With Lissamine Green in the Worse Eye
Time frame: Baseline, Month 6
Total corneal staining with lissamine green is measured in the worse eye utilizing the Ora CalibraTM Corneal Lissamine Staining Scale (0 to 4 scale where 0=no staining and 4= severe staining). The sum of the total includes 3 regions of the cornea, resulting in a maximum possible score of 12 (severe staining score of 4 in all three regions). A negative change from baseline represents a decrease in staining (improvement). A positive change from baseline represents an increase in staining (worsening).
Change From Baseline in Total Conjunctival Staining Score With Lissamine Green in the Worse Eye
Time frame: Baseline, Month 6
Total conjunctival staining with lissamine is measured in the worse eye utilizing the Ora CalibraTM Conjunctiva Lissamine Staining Scale (0 to 4 scale where 0=no staining and 4= severe staining). The sum of the total includes 2 regions of the conjunctiva, resulting in a maximum possible score of 8 (severe staining score of 4 in both regions). A negative change from baseline represents a decrease in staining (improvement). A positive change from baseline represents an increase in staining (worsening).
Change From Baseline in Reading on the Ocular Surface Disease Index (OSDI)
Time frame: Baseline, Month 6
The OSDI consists of 12 questions measuring the presence of ocular symptoms. The reading question is assessed using a 5-point scale (0=none of the time; 4=all of the time). The reading score is converted to a 0-100 score where 0 is best and 100 is worst. Higher OSDI reading scores are associated with greater severity. A negative number change from baseline indicates improvement and a positive number change from baseline indicates worsening.
Change From Baseline in Driving at Night on the OSDI
Time frame: Baseline, Month 6
The OSDI consists of 12 questions measuring the presence of ocular symptoms. The driving at night question is assessed using a 5-point scale (0=none of the time; 4=all of the time). The driving at night score is converted to a 0-100 score where 0 is best and 100 is worst. Higher OSDI reading scores are associated with greater severity. A negative number change from baseline indicates improvement and a positive number change from baseline indicates worsening.
Change From Baseline in Working With a Computer or Bank Machine on the OSDI
Time frame: Baseline, Month 6
The OSDI consists of 12 questions measuring the presence of ocular symptoms. The working with a computer or bank machine question is assessed using a 5-point scale (0=none of the time; 4=all of the time). The working with a computer or bank machine score is converted to a 0-100 score where 0 is best and 100 is worst. Higher OSDI reading scores are associated with greater severity. A negative number change from baseline indicates improvement and a positive number change from baseline indicates worsening.
Change From Baseline in Watching TV on the OSDI
Time frame: Baseline, Month 6
The OSDI consists of 12 questions measuring the presence of ocular symptoms. The watching TV question is assessed using a 5-point scale (0=none of the time; 4=all of the time). The watching TV score is converted to a 0-100 score where 0 is best and 100 is worst. Higher OSDI reading scores are associated with greater severity. A negative number change from baseline indicates improvement and a positive number change from baseline indicates worsening.
Change From Baseline in Reading Rate
Time frame: Baseline, Month 6
Reading speed is assessed as the number of words read correctly in 2 minutes.
Change From Baseline in Words Read Incorrectly
Time frame: Baseline, Month 6
The numbers of words read incorrectly are counted in 2 minutes. A positive change from baseline indicates a worsening, and a negative change from baseline indicates an improvement.
Change From Baseline in Font Size
Time frame: Baseline, Month 6
The minimum font (letter) size read correctly is assessed. Smaller font size indicates better ability. A negative change from baseline indicates an improvement and a positive change from baseline indicates a worsening.

5 secondary outcomes

Change From Baseline in OSDI
Time frame: Baseline, Month 6
Change From Baseline in Ocular Discomfort on a 4-point Scale
Time frame: Baseline, Month 6
Change From Baseline in Tear Film Break-up Time in the Worse Eye
Time frame: Baseline, Month 6
Change From Baseline in the Interblink Interval in the Worse Eye
Time frame: Baseline, Month 6
Change From Baseline in Conjunctival Redness in the Worse Eye
Time frame: Baseline, Month 6

Results and safety

Results posted to the registry on 25 Apr 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Cyclosporine 0.05% Ophthalmic Emulsion	40	37

Primary outcome: Change From Baseline in Total Corneal Staining Score With Fluorescein in the Worse Eye

Time frame: Baseline, Month 6. Mean (Standard Deviation). Unit: Scores on a Scale

Measure	Cyclosporine 0.05% Ophthalmic Emulsion n = 40
Baseline	7.29 (1.409)
Change from Baseline at Month 6 (N=37)	-1.96 (1.677)

Population analysed: Intent-to-Treat: all enrolled patients who received at least one dose of the study drug

Primary outcome: Change From Baseline in Total Conjunctival Staining Score With Fluorescein in the Worse Eye

Time frame: Baseline, Month 6. Mean (Standard Deviation). Unit: Scores on a Scale

Measure	Cyclosporine 0.05% Ophthalmic Emulsion n = 40
Baseline	4.68 (1.035)
Change from Baseline at Month 6 (N=37)	0.11 (1.162)

Population analysed: Intent-to-Treat: all enrolled patients who received at least one dose of the study drug

Primary outcome: Change From Baseline in Total Corneal Staining Score With Lissamine Green in the Worse Eye

Time frame: Baseline, Month 6. Mean (Standard Deviation). Unit: Scores on a Scale

Measure	Cyclosporine 0.05% Ophthalmic Emulsion n = 40
Baseline	4.43 (1.389)
Change from Baseline at Month 6 (N=37)	-0.93 (1.439)

Population analysed: Intent-to-Treat: all enrolled patients who received at least one dose of the study drug

Primary outcome: Change From Baseline in Total Conjunctival Staining Score With Lissamine Green in the Worse Eye

Time frame: Baseline, Month 6. Mean (Standard Deviation). Unit: Scores on a Scale

Measure	Cyclosporine 0.05% Ophthalmic Emulsion n = 40
Baseline	4.21 (1.255)
Change from Baseline at Month 6 (N=37)	0.30 (1.356)

Population analysed: Intent-to-Treat: all enrolled patients who received at least one dose of the study drug

5 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Cyclosporine 0.05% Ophthalmic Emulsion	2 of 40 (5%)	12 of 40 (30%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 27257373Stonecipher KG, Torkildsen GL, Ousler GW 3rd, Morris S, Villanueva L, Hollander DA. The IMPACT study: a prospective evaluation of the effects of cyclosporine ophthalmic emulsion 0.05% on ocular surface staining and visual performance in patients with dry eye. Clin Ophthalmol. 2016 May 13;10:887-95. doi: 10.2147/OPTH.S101627. eCollection 2016.

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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.

Medical Director study director

Allergan

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 cyclosporine 0.05% ophthalmic emulsion and carboxymethylcellulose-based lubricant eye drops in people with Dry Eye Syndromes, run by Allergan at 1 site in United States.

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: finished, as of the sponsor's last update on 18 Apr 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 United States. 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 25 Apr 2016). 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 in Total Corneal Staining Score With Fluorescein in the Worse Eye (time frame: Baseline, Month 6). The study lists 11 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 NCT02121847, which also lists 1 linked publication.

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 Apr 2019.