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

Primary Purpose

Dry Eye Syndromes

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Cyclosporine 0.05% Ophthalmic Emulsion
Sponsored by
Allergan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dry Eye Syndromes

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion:

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

Exclusion:

  • 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.
  • 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.

Sites / Locations

  • Andover Eye Associates, Inc
  • Total Eye Care, PA

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

RESTASIS®

Arm Description

1 drop of RESTASIS® ophthalmic emulsion instilled in each eye twice a day for 6 months.

Outcomes

Primary Outcome Measures

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).
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).
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).
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).
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).
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).
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.
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.
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).
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).

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.

Full Information

First Posted
September 17, 2015
Last Updated
May 25, 2017
Sponsor
Allergan
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1. Study Identification

Unique Protocol Identification Number
NCT02554981
Brief Title
Evaluation of Maintaining Visual Performance in Participants Who Engage in Electronic Visual Tasking While Using Restasis®
Acronym
EMPOWER
Official Title
Evaluation of Maintaining Visual Performance Of Subjects Who Engage in Electronic Visual Tasking While Using Restasis (EMPOWER)
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
July 21, 2015 (Actual)
Primary Completion Date
March 24, 2016 (Actual)
Study Completion Date
March 24, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Allergan

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Eye Syndromes

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
51 (Actual)

8. Arms, Groups, and Interventions

Arm Title
RESTASIS®
Arm Type
Experimental
Arm Description
1 drop of RESTASIS® ophthalmic emulsion instilled in each eye twice a day for 6 months.
Intervention Type
Drug
Intervention Name(s)
Cyclosporine 0.05% Ophthalmic Emulsion
Other Intervention Name(s)
RESTASIS®
Intervention Description
Cyclosporine 0.05% Ophthalmic Emulsion (RESTASIS®) 1 drop instilled in each eye twice a day.
Primary Outcome Measure Information:
Title
Change From Baseline in the Total Corneal Staining Score With Fluorescein in the Worse Eye
Description
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).
Time Frame
Baseline, Month 6
Title
Change From Baseline in the Total Conjunctival Staining Score With Fluorescein in the Worse Eye
Description
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).
Time Frame
Baseline, Month 6
Title
Change From Baseline in the Central Region Staining Score With Fluorescein in the Worse Eye
Description
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).
Time Frame
Baseline, Month 6
Title
Change From Baseline in the Total Corneal Staining Score With Lissamine Green in the Worse Eye
Description
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).
Time Frame
Baseline, Month 6
Title
Change From Baseline in the Total Conjunctival Staining Score With Lissamine Green in the Worse Eye
Description
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).
Time Frame
Baseline, Month 6
Title
Change From Baseline in the Central Region Staining Score With Lissamine Green in the Worse Eye
Description
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).
Time Frame
Baseline, Month 6
Title
Change From Baseline in Font Size
Description
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.
Time Frame
Baseline, Month 6
Title
Change From Baseline in Words Read Incorrectly
Description
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.
Time Frame
Baseline, Month 6
Title
Change From Baseline in Time to Read Passage
Description
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).
Time Frame
Baseline, Month 6
Title
Change From Baseline in Reading Rate
Description
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).
Time Frame
Baseline, Month 6
Secondary Outcome Measure Information:
Title
Change From Baseline in Tear Film Break Up Time (TFBUT) in the Worse Eye
Description
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.
Time Frame
Baseline, Month 6
Title
Change From Baseline in Ocular Protection Index (OPI) 2.0 in the Worse Eye
Description
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.
Time Frame
Baseline, Month 6
Title
Change From Baseline in Interblink Interval (IBI) in the Worst Eye
Description
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.
Time Frame
Baseline, Month 6
Title
Change From Baseline in OSDI© Total Score
Description
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.
Time Frame
Baseline, Month 6
Title
Change From Baseline in Driving at Night on the OSDI©
Description
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.
Time Frame
Baseline, Month 6
Title
Change From Baseline in Working With a Computer or Bank Machine on the OSDI©
Description
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.
Time Frame
Baseline, Month 6
Title
Change From Baseline in Watching Television (TV) on the OSDI©
Description
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.
Time Frame
Baseline, Month 6
Title
Change From Baseline in Blurred Vision on the OSDI©
Description
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.
Time Frame
Baseline, Month 6
Title
Change From Baseline in Poor Vision on the OSDI©
Description
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.
Time Frame
Baseline, Month 6
Title
Change From Baseline in Reading on the OSDI©
Description
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.
Time Frame
Baseline, Month 6
Title
Change From Baseline in the Ocular Discomfort Scale Post Wilkins Test in the Worst Eye
Description
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.
Time Frame
Baseline, Month 6

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion: Has Eye Symptoms when using video display terminals Has a reported history of dry eye in both eyes. Exclusion: 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. 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jai Parekh
Organizational Affiliation
Allergan
Official's Role
Study Director
Facility Information:
Facility Name
Andover Eye Associates, Inc
City
Andover
State/Province
Massachusetts
ZIP/Postal Code
01810
Country
United States
Facility Name
Total Eye Care, PA
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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