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

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

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

Conditions
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Dry Eye Syndromes

Intervention / Treatment
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* Drug: Cyclosporine 0.05% Ophthalmic Emulsion


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: RESTASIS®<br>1 drop of RESTASIS® ophthalmic emulsion instilled in each eye twice a day for 6 months. | Drug: Cyclosporine 0.05% Ophthalmic Emulsion<br>* Cyclosporine 0.05% Ophthalmic Emulsion (RESTASIS®) 1 drop instilled in each eye twice a day.<br>* Other names: RESTASIS®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 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). | 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). | 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). | 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). | 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). | 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. | 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. | 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). | 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). | Baseline, Month 6 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | Baseline, Month 6 |