Dry Eye SyndromesPhase 4EMPOWERNCT02554981

Evaluation of Maintaining Visual Performance in Participants Who Engage in Electronic Visual Tasking While Using Restasis®

A Phase 4 study testing Cyclosporine 0.05% Ophthalmic Emulsion in people with Dry Eye Syndromes, run by Allergan at 2 sites 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 efficacy of Restasis® in participants with dry eye disease who engage in electronic visual tasking. Read more about this study

Who is it for?: Ages 18 to 55 years
Conditions the study is for: Dry Eye Syndromes
What is being tested?: Cyclosporine 0.05% Ophthalmic Emulsion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 51 participants
Where: 2 sitesUnited States
Study dates: 21 Jul 2015to 24 Mar 2016
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 to 55 years
All sexes
No healthy volunteers
Adult

Who may be able to join

Has Eye Symptoms when using video display terminals
Has a reported history of dry eye in both eyes.

Who cannot join

Diagnosed with eye infection or active inflammation.
Has worn contact lenses within the past 7 days or anticipated use during the study.
Has used any eye drops within 2 hours.
Has had laser-assisted in situ keratomileusis (LASIK) within 12 months.
Has used Restasis® within 90 days.
Has had any eye and or/lid surgeries within 6 months.

Show all 10Show fewer

Has had cataract surgery in either eye.
Has current punctal occlusion or anticipate a change in punctal occlusion status at any point during the study.
Is currently taking any topical ophthalmic prescriptions or over-the-counter solutions, artificial tears, gels or lid scrubs that cannot be discontinued for the trial duration.
Use of medication known to cause ocular drying that is not on a stable dose for at least 30 days.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

Andover Eye Associates, Inc
Andover, Massachusetts, 01810
Total Eye Care, PA
Memphis, Tennessee, 38119

Other trials in United States

About this study

Official title: Evaluation of Maintaining Visual Performance Of Subjects Who Engage in Electronic Visual Tasking While Using Restasis (EMPOWER)

This study will evaluate the efficacy of Restasis® in participants with dry eye disease who engage in electronic visual tasking.

Conditions: Dry Eye Syndromes
Being tested: Cyclosporine 0.05% Ophthalmic Emulsion
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®) 1 drop instilled in each eye twice a day.

Study groups in NCT02554981
Study group	Role	What they receive
RESTASIS®	Experimental	1 drop of RESTASIS® ophthalmic emulsion instilled in each eye twice a day for 6 months. Receives: Drug: Cyclosporine 0.05% Ophthalmic Emulsion

What is being measured

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

Change From Baseline in the Total Corneal Staining Score With Fluorescein in the Worse Eye
Total corneal staining with fluorescein was measured in the worse eye using the Ora Calibra™ (Scale 1.0) 5-point scale where 0= none (best), no staining to 4=severe staining (worst). 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). The worse eye is defined as the worst eye at Baseline. A negative change from Baseline represents a decrease in staining (improvement).
Measured: Baseline, Month 6
Change From Baseline in the Total Conjunctival Staining Score With Fluorescein in the Worse Eye
Total conjunctival staining with fluorescein was measured in the worse eye using the Ora Calibra™ (Scale 1.0) 5-point scale where 0= none (best), no staining to 4=severe staining (worst). 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). The worse eye is defined as the worst eye at Baseline. A negative change from Baseline represents a decrease in staining (improvement).
Measured: Baseline, Month 6
Change From Baseline in the Central Region Staining Score With Fluorescein in the Worse Eye
Staining with fluorescein in the central region of the eye was measured in the worse eye using the Ora Calibra™ (Scale 1.0) 5-point scale where 0= none (best), no staining to 4=severe staining (worst). The worse eye is defined as the worst eye at Baseline. A negative change from Baseline represents a decrease in staining (improvement).
Measured: Baseline, Month 6
Change From Baseline in the Total Corneal Staining Score With Lissamine Green in the Worse Eye
Total corneal staining with lissamine green was measured in the worse eye using the Ora Calibra™ (Scale 1.0) 5-point scale where 0= none (best), no staining to 4=severe staining (worst). 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). The worse eye is defined as the worst eye at Baseline. A negative change from Baseline represents a decrease in staining (improvement).
Measured: Baseline, Month 6
Change From Baseline in the Total Conjunctival Staining Score With Lissamine Green in the Worse Eye
Total conjunctival staining with lissamine green was measured in the worse eye using the Ora Calibra™ (Scale 1.0) 5-point scale where 0= none (best), no staining to 4=severe staining (worst). 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). The worse eye is defined as the worst eye at Baseline. A negative change from Baseline represents a decrease in staining (improvement).
Measured: Baseline, Month 6
Change From Baseline in the Central Region Staining Score With Lissamine Green in the Worse Eye
Staining with lissamine green in the central region of the eye was measured in the worse eye using the Ora Calibra™ (Scale 1.0) 5-point scale where 0= none (best), no staining to 4=severe staining (worst). The worse eye is defined as the worst eye at Baseline. A negative change from Baseline represents a decrease in staining (improvement).
Measured: Baseline, Month 6
Change From Baseline in Font Size
The minimum font (letter) size read correctly was assessed. Smaller font size (less points) indicates better ability. A negative change from Baseline indicates an improvement and a positive change from Baseline indicates a worsening.
Measured: Baseline, Month 6
Change From Baseline in Words Read Incorrectly
The numbers of words read incorrectly are counted. A positive change from Baseline indicates a worsening (more words read incorrectly) and a negative change from Baseline indicates an improvement.
Measured: Baseline, Month 6
Change From Baseline in Time to Read Passage
The time to read passage (selected portion of text ) in seconds was assessed. A negative change from Baseline indicates an improvement (less time to read the passage).
Measured: Baseline, Month 6
Change From Baseline in Reading Rate
Reading speed was assessed as the number of words read correctly calculated as words/minute. A positive change from Baseline indicates an improvement (more words read correctly/minute) and a negative change from Baseline indicates a worsening (less words read correctly/minute).
Measured: Baseline, Month 6

Secondary outcomes (11)

Change From Baseline in Tear Film Break Up Time (TFBUT) 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. The worse eye is defined as the Worse Eye at Baseline. 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 Ocular Protection Index (OPI) 2.0 in the Worse Eye
A device was used to assess OPI 2.0. This technology measures blink and tear film break-up area. These values demonstrate the average area of tear deficiency/corneal exposure. The worse eye is defined as the worse eye at Baseline. A negative value indicates an improvement in corneal protection.
Measured: Baseline, Month 6
Change From Baseline in Interblink Interval (IBI) in the Worst Eye
A device was used to assess IBI. The IBI measures the time in 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 OSDI© Total Score
The OSDI© questionnaire consists of 12 questions measuring the presence of ocular symptoms. Each of the 12 questions was assessed using a 5-point scale (where 0=none of the time and 4=all of the time). The score is converted to a 0 to 100 point score where 0 is no symptoms and 100 is most symptoms. A negative change from Baseline indicates improvement.
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 was assessed using a 5-point scale (0=none of the time to 4=all of the time). 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 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 was assessed using a 5-point scale (0=none of the time to 4=all of the time). 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 Watching Television (TV) on the OSDI©
The OSDI© consists of 12 questions measuring the presence of ocular symptoms. The Watching TV question was assessed using a 5-point scale (0=none of the time to 4=all of the time). 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 Blurred Vision on the OSDI©
The OSDI© consists of 12 questions measuring the presence of ocular symptoms. The Blurred Vision question was assessed using a 5-point scale (0=none of the time to 4=all of the time). 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 Poor Vision on the OSDI©
The OSDI© consists of 12 questions measuring the presence of ocular symptoms. The Poor Vision question was assessed using a 5-point scale (0=none of the time to 4=all of the time). 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 Reading on the OSDI©
The OSDI© consists of 12 questions measuring the presence of ocular symptoms. The Reading question was assessed using a 5-point scale (0=none of the time to 4=all of the time). 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 the Ocular Discomfort Scale Post Wilkins Test in the Worst Eye
Participants assessed ocular discomfort post Wilkins Rate of Reading Test using the Ora Calibra™ 5-point scale where 0=no discomfort to 4=constant discomfort. 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.

21 Jul 201524 Mar 2016

First posted21 Sep 2015 (estimated)
Study start21 Jul 2015
Primary completion24 Mar 2016
Study completion24 Mar 2016

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 4
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 51 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02554981
Sponsor's protocol ID: MA-RES-015-001
Acronym: EMPOWER
Status last verified: May 2017
First submitted: 17 Sep 2015
Last updated: 1 Jun 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: 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?

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Study at a glance

From the registry record, last updated by the sponsor on 1 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluation of Maintaining Visual Performance Of Subjects Who Engage in Electronic Visual Tasking While Using Restasis (EMPOWER)
ClinicalTrials.gov ID: NCT02554981
Acronym / sponsor ID: EMPOWER / MA-RES-015-001
Conditions: Dry Eye Syndromes
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 51 participants (actual)
Lead sponsor: AllerganIndustry (pharma, biotech, devices)
Study start: 21 Jul 2015 (actual)
Primary completion: 24 Mar 2016 (actual)
Study completion: 24 Mar 2016 (actual)
First posted: 21 Sep 2015 (estimated)
Results: Posted 1 Jun 2017

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 efficacy of Restasis® in participants with dry eye disease who engage in electronic visual tasking.

Study design

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

Arm	Type	Receives
RESTASIS®	Experimental	Drug: Cyclosporine 0.05% Ophthalmic Emulsion1 drop of RESTASIS® ophthalmic emulsion instilled in each eye twice a day for 6 months.

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (2 listed)

Has Eye Symptoms when using video display terminals
Has a reported history of dry eye in both eyes.

Key exclusion criteria (10 listed)

Diagnosed with eye infection or active inflammation.
Has worn contact lenses within the past 7 days or anticipated use during the study.
Has used any eye drops within 2 hours.
Has had laser-assisted in situ keratomileusis (LASIK) within 12 months.
Has used Restasis® within 90 days.

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®) 1 drop instilled in each eye twice a day.	Drug	RESTASIS®

Primary outcome

Change From Baseline in the Total Corneal Staining Score With Fluorescein in the Worse Eye
Time frame: Baseline, Month 6
Total corneal staining with fluorescein was measured in the worse eye using the Ora Calibra™ (Scale 1.0) 5-point scale where 0= none (best), no staining to 4=severe staining (worst). 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). The worse eye is defined as the worst eye at Baseline. A negative change from Baseline represents a decrease in staining (improvement).
Change From Baseline in the Total Conjunctival Staining Score With Fluorescein in the Worse Eye
Time frame: Baseline, Month 6
Total conjunctival staining with fluorescein was measured in the worse eye using the Ora Calibra™ (Scale 1.0) 5-point scale where 0= none (best), no staining to 4=severe staining (worst). 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). The worse eye is defined as the worst eye at Baseline. A negative change from Baseline represents a decrease in staining (improvement).
Change From Baseline in the Central Region Staining Score With Fluorescein in the Worse Eye
Time frame: Baseline, Month 6
Staining with fluorescein in the central region of the eye was measured in the worse eye using the Ora Calibra™ (Scale 1.0) 5-point scale where 0= none (best), no staining to 4=severe staining (worst). The worse eye is defined as the worst eye at Baseline. A negative change from Baseline represents a decrease in staining (improvement).
Change From Baseline in the Total Corneal Staining Score With Lissamine Green in the Worse Eye
Time frame: Baseline, Month 6
Total corneal staining with lissamine green was measured in the worse eye using the Ora Calibra™ (Scale 1.0) 5-point scale where 0= none (best), no staining to 4=severe staining (worst). 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). The worse eye is defined as the worst eye at Baseline. A negative change from Baseline represents a decrease in staining (improvement).
Change From Baseline in the Total Conjunctival Staining Score With Lissamine Green in the Worse Eye
Time frame: Baseline, Month 6
Total conjunctival staining with lissamine green was measured in the worse eye using the Ora Calibra™ (Scale 1.0) 5-point scale where 0= none (best), no staining to 4=severe staining (worst). 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). The worse eye is defined as the worst eye at Baseline. A negative change from Baseline represents a decrease in staining (improvement).
Change From Baseline in the Central Region Staining Score With Lissamine Green in the Worse Eye
Time frame: Baseline, Month 6
Staining with lissamine green in the central region of the eye was measured in the worse eye using the Ora Calibra™ (Scale 1.0) 5-point scale where 0= none (best), no staining to 4=severe staining (worst). The worse eye is defined as the worst eye at Baseline. A negative change from Baseline represents a decrease in staining (improvement).
Change From Baseline in Font Size
Time frame: Baseline, Month 6
The minimum font (letter) size read correctly was assessed. Smaller font size (less points) indicates better ability. A negative change from Baseline indicates an improvement and a positive change from Baseline indicates a worsening.
Change From Baseline in Words Read Incorrectly
Time frame: Baseline, Month 6
The numbers of words read incorrectly are counted. A positive change from Baseline indicates a worsening (more words read incorrectly) and a negative change from Baseline indicates an improvement.
Change From Baseline in Time to Read Passage
Time frame: Baseline, Month 6
The time to read passage (selected portion of text ) in seconds was assessed. A negative change from Baseline indicates an improvement (less time to read the passage).
Change From Baseline in Reading Rate
Time frame: Baseline, Month 6
Reading speed was assessed as the number of words read correctly calculated as words/minute. A positive change from Baseline indicates an improvement (more words read correctly/minute) and a negative change from Baseline indicates a worsening (less words read correctly/minute).

11 secondary outcomes

Change From Baseline in Tear Film Break Up Time (TFBUT) in the Worse Eye
Time frame: Baseline, Month 6
Change From Baseline in Ocular Protection Index (OPI) 2.0 in the Worse Eye
Time frame: Baseline, Month 6
Change From Baseline in Interblink Interval (IBI) in the Worst Eye
Time frame: Baseline, Month 6
Change From Baseline in OSDI© Total Score
Time frame: Baseline, Month 6
Change From Baseline in Driving at Night on the OSDI©
Time frame: Baseline, Month 6
Change From Baseline in Working With a Computer or Bank Machine on the OSDI©
Time frame: Baseline, Month 6
Change From Baseline in Watching Television (TV) on the OSDI©
Time frame: Baseline, Month 6
Change From Baseline in Blurred Vision on the OSDI©
Time frame: Baseline, Month 6
Change From Baseline in Poor Vision on the OSDI©
Time frame: Baseline, Month 6
Change From Baseline in Reading on the OSDI©
Time frame: Baseline, Month 6
Change From Baseline in the Ocular Discomfort Scale Post Wilkins Test in the Worst Eye
Time frame: Baseline, Month 6

Results and safety

Results posted to the registry on 1 Jun 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
RESTASIS®	51	46

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

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

Measure	RESTASIS® n = 50
Baseline	7.05 (1.011)
Change from Baseline at Month 6	-1.51 (1.466)

Population analysed: ITT population included all enrolled participants who received at least one dose of the study drug. "n" in the category is the number of participants with data available at the given time-point.

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

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

Measure	RESTASIS® n = 50
Baseline	4.57 (1.237)
Change from Baseline at Month 6	-0.61 (1.238)

Primary outcome: Change From Baseline in the Central Region Staining Score With Fluorescein in the Worse Eye

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

Measure	RESTASIS® n = 50
Baseline	2.29 (0.441)
Change from Baseline at Month 6	-0.75 (0.656)

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

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

Measure	RESTASIS® n = 50
Baseline	4.00 (1.378)
Change from Baseline at Month 6	-0.34 (1.418)

11 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
RESTASIS®	3 of 50 (6%)	6 of 50 (12%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2017.
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.

Jai Parekh study director

Allergan

2 sites 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 in people with Dry Eye Syndromes, run by Allergan at 2 sites 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 10 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 1 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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 1 Jun 2017). 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 the Total Corneal Staining Score With Fluorescein in the Worse Eye (time frame: Baseline, Month 6). The study lists 10 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 NCT02554981.

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 1 Jun 2017.