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

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ClinicalTrials.gov Identifier: NCT02554981
Recruitment Status : Completed
First Posted : September 21, 2015
Results First Posted : June 1, 2017
Last Update Posted : June 1, 2017
Sponsor:
Information provided by (Responsible Party):
Allergan

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

Condition or disease Intervention/treatment Phase
Dry Eye Syndromes Drug: Cyclosporine 0.05% Ophthalmic Emulsion Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 51 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of Maintaining Visual Performance Of Subjects Who Engage in Electronic Visual Tasking While Using Restasis (EMPOWER)
Actual Study Start Date : July 21, 2015
Actual Primary Completion Date : March 24, 2016
Actual Study Completion Date : March 24, 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: RESTASIS®
1 drop of RESTASIS® ophthalmic emulsion instilled in each eye twice a day for 6 months.
Drug: Cyclosporine 0.05% Ophthalmic Emulsion
Cyclosporine 0.05% Ophthalmic Emulsion (RESTASIS®) 1 drop instilled in each eye twice a day.
Other Name: RESTASIS®




Primary Outcome Measures :
  1. 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).

  2. 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).

  3. 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).

  4. 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).

  5. 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).

  6. 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).

  7. 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.

  8. 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.

  9. 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).

  10. 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).


Secondary Outcome Measures :
  1. Change From Baseline in Tear Film Break Up Time (TFBUT) in the Worse Eye [ Time Frame: Baseline, Month 6 ]
    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.

  2. Change From Baseline in Ocular Protection Index (OPI) 2.0 in the Worse Eye [ Time Frame: Baseline, Month 6 ]
    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.

  3. Change From Baseline in Interblink Interval (IBI) in the Worst Eye [ Time Frame: Baseline, Month 6 ]
    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.

  4. Change From Baseline in OSDI© Total Score [ Time Frame: Baseline, Month 6 ]
    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.

  5. 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 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.

  6. 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 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.

  7. Change From Baseline in Watching Television (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 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.

  8. Change From Baseline in Blurred Vision on the OSDI© [ Time Frame: Baseline, Month 6 ]
    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.

  9. Change From Baseline in Poor Vision on the OSDI© [ Time Frame: Baseline, Month 6 ]
    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.

  10. Change From Baseline in Reading on the OSDI© [ Time Frame: Baseline, Month 6 ]
    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.

  11. Change From Baseline in the Ocular Discomfort Scale Post Wilkins Test in the Worst Eye [ Time Frame: Baseline, Month 6 ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02554981


Locations
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United States, Massachusetts
Andover Eye Associates, Inc
Andover, Massachusetts, United States, 01810
United States, Tennessee
Total Eye Care, PA
Memphis, Tennessee, United States, 38119
Sponsors and Collaborators
Allergan
Investigators
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Study Director: Jai Parekh Allergan
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Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT02554981    
Other Study ID Numbers: MA-RES-015-001
First Posted: September 21, 2015    Key Record Dates
Results First Posted: June 1, 2017
Last Update Posted: June 1, 2017
Last Verified: May 2017
Additional relevant MeSH terms:
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Dry Eye Syndromes
Lacrimal Apparatus Diseases
Eye Diseases
Cyclosporine
Cyclosporins
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antifungal Agents
Anti-Infective Agents
Dermatologic Agents
Antirheumatic Agents
Calcineurin Inhibitors