Investigation of Maintaining Visual Performance Achieved With Cyclosporine Therapy

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

Conditions
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Dry Eye Syndromes

Intervention / Treatment
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* Drug: cyclosporine 0.05% ophthalmic emulsion
* Drug: carboxymethylcellulose-based lubricant eye drops


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: History of dry eye in both eyes Willing to use eye drops for dry eye symptoms Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 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: cyclosporine 0.05% ophthalmic emulsion<br>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. | Drug: cyclosporine 0.05% ophthalmic emulsion<br>* Cyclosporine 0.05% ophthalmic emulsion (Restasis®) eye drops administered twice daily for 6 months.<br>* Other names: Restasis®;Drug: carboxymethylcellulose-based lubricant eye drops<br>* Carboxymethylcellulose-based lubricant eye drops (Refresh OPTIVE® Advanced) administered as needed for 6 months.<br>* Other names: Refresh OPTIVE® Advanced;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 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). | 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). | 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). | 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. | 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. | 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. | 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. | Baseline, Month 6 | 
| Change From Baseline in Reading Rate | Reading speed is assessed as the number of words read correctly in 2 minutes. | 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. | 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. | Baseline, Month 6 | 

Secondary Outcome Measures

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