Investigation of Maintaining Visual Performance Achieved With Cyclosporine Therapy
- Conditions
- Dry Eye Syndromes
- Interventions
- Drug: carboxymethylcellulose-based lubricant eye drops
- Registration Number
- NCT02121847
- Lead Sponsor
- Allergan
- Brief Summary
This study will evaluate the safety and efficacy of cyclosporine 0.05% ophthalmic emulsion (Restasis®) in patients with dry eye disease.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 40
- History of dry eye in both eyes
- Willing to use eye drops for dry eye symptoms
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description cyclosporine 0.05% ophthalmic emulsion cyclosporine 0.05% ophthalmic emulsion 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. cyclosporine 0.05% ophthalmic emulsion carboxymethylcellulose-based lubricant eye drops 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.
- Primary Outcome Measures
Name Time Method Change From Baseline in Total Corneal Staining Score With Lissamine Green in the Worse Eye Baseline, Month 6 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).
Change From Baseline in Driving at Night on the OSDI Baseline, Month 6 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.
Change From Baseline in Total Corneal Staining Score With Fluorescein in the Worse Eye Baseline, Month 6 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).
Change From Baseline in Total Conjunctival Staining Score With Lissamine Green in the Worse Eye Baseline, Month 6 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).
Change From Baseline in Total Conjunctival Staining Score With Fluorescein in the Worse Eye Baseline, Month 6 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).
Change From Baseline in Working With a Computer or Bank Machine on the OSDI Baseline, Month 6 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.
Change From Baseline in Reading Rate Baseline, Month 6 Reading speed is assessed as the number of words read correctly in 2 minutes.
Change From Baseline in Words Read Incorrectly Baseline, Month 6 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.
Change From Baseline in Reading on the Ocular Surface Disease Index (OSDI) Baseline, Month 6 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.
Change From Baseline in Watching TV on the OSDI Baseline, Month 6 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.
Change From Baseline in Font Size Baseline, Month 6 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.
- Secondary Outcome Measures
Name Time Method Change From Baseline in Ocular Discomfort on a 4-point Scale Baseline, Month 6 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.
Change From Baseline in Tear Film Break-up Time in the Worse Eye 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. A positive number change from baseline indicates improvement and a negative number change from baseline indicates a worsening.
Change From Baseline in OSDI Baseline, Month 6 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.
Change From Baseline in the Interblink Interval in the Worse Eye Baseline, Month 6 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.
Change From Baseline in Conjunctival Redness in the Worse Eye Baseline, Month 6 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.