Evaluation of Maintaining Visual Performance in Participants Who Engage in Electronic Visual Tasking While Using Restasis®
- Conditions
- Dry Eye Syndromes
- Interventions
- Registration Number
- NCT02554981
- Lead Sponsor
- Allergan
- Brief Summary
This study will evaluate the efficacy of Restasis® in participants with dry eye disease who engage in electronic visual tasking.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 51
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description RESTASIS® Cyclosporine 0.05% Ophthalmic Emulsion 1 drop of RESTASIS® ophthalmic emulsion instilled in each eye twice a day for 6 months.
- Primary Outcome Measures
Name Time Method Change From Baseline in the Total Corneal Staining Score With Fluorescein in the Worse Eye 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).
Change From Baseline in the Total Conjunctival Staining Score With Fluorescein in the Worse Eye 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).
Change From Baseline in the Central Region Staining Score With Fluorescein in the Worse Eye 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).
Change From Baseline in the Total Corneal Staining Score With Lissamine Green in the Worse Eye 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).
Change From Baseline in the Total Conjunctival Staining Score With Lissamine Green in the Worse Eye 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).
Change From Baseline in Font Size 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.
Change From Baseline in the Central Region Staining Score With Lissamine Green in the Worse Eye 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).
Change From Baseline in Words Read Incorrectly 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.
Change From Baseline in Reading Rate 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).
Change From Baseline in Time to Read Passage 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).
- Secondary Outcome Measures
Name Time Method 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 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 Tear Film Break Up Time (TFBUT) 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. 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 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.
Change From Baseline in Interblink Interval (IBI) in the Worst Eye 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.
Change From Baseline in OSDI© Total Score 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.
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 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© 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.
Change From Baseline in Blurred Vision on the OSDI© 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.
Change From Baseline in Poor Vision on the OSDI© 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.
Change From Baseline in Reading on the OSDI© 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.
Change From Baseline in the Ocular Discomfort Scale Post Wilkins Test in the Worst Eye 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.
Trial Locations
- Locations (2)
Andover Eye Associates, Inc
🇺🇸Andover, Massachusetts, United States
Total Eye Care, PA
🇺🇸Memphis, Tennessee, United States