Dry Eye Syndromes
Conditions
Brief summary
This study will evaluate the efficacy of Restasis® in participants with dry eye disease who engage in electronic visual tasking.
Interventions
Cyclosporine 0.05% Ophthalmic Emulsion (RESTASIS®) 1 drop instilled in each eye twice a day.
Sponsors
Allergan
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No
Inclusion 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 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 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 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 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). |
| 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 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. |
| 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 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 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| RESTASIS® 1 drop of RESTASIS® ophthalmic emulsion instilled in each eye twice a day for 6 months. | 50 |
| Total | 50 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Administrative Reasons | 1 |
| Overall Study | Adverse Event | 1 |
| Overall Study | Other Miscellaneous Reasons | 3 |
Baseline characteristics
| Characteristic | RESTASIS® |
|---|---|
| Age, Continuous | 46.3 years STANDARD_DEVIATION 8.3 |
| Sex: Female, Male Female | 41 Participants |
| Sex: Female, Male Male | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 6 / 50 |
| serious Total, serious adverse events | 3 / 50 |
Outcome results
Primary
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.
Time frame: Baseline, Month 6
Population: ITT population was defined as all enrolled participants who received at least one dose of study drug. n in the category is the number of participants with data available at the given time-point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| RESTASIS® | Change From Baseline in Font Size | Baseline | 9.0 points | Standard Deviation 0 |
| RESTASIS® | Change From Baseline in Font Size | Change from Baseline at Month 6 | 0.0 points | Standard Deviation 0.21 |
Primary
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).
Time frame: Baseline, Month 6
Population: ITT population was defined as all enrolled participants who received at least one dose of study drug. n in the category is the number of participants with data available at the given time-point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| RESTASIS® | Change From Baseline in Reading Rate | Baseline | 146.6 correct words/minute | Standard Deviation 64.18 |
| RESTASIS® | Change From Baseline in Reading Rate | Change from Baseline at Month 6 | -3.6 correct words/minute | Standard Deviation 69.8 |
Primary
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).
Time frame: Baseline, Month 6
Population: ITT population included all enrolled participants who received at least one dose of the study drug. n in the category is the number of participants with data available at the given time-point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| RESTASIS® | Change From Baseline in the Central Region Staining Score With Fluorescein in the Worse Eye | Baseline | 2.29 score on a scale | Standard Deviation 0.441 |
| RESTASIS® | Change From Baseline in the Central Region Staining Score With Fluorescein in the Worse Eye | Change from Baseline at Month 6 | -0.75 score on a scale | Standard Deviation 0.656 |
Primary
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).
Time frame: Baseline, Month 6
Population: ITT population included all enrolled participants who received at least one dose of the study drug. n in the category is the number of participants with data available at the given time-point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| RESTASIS® | Change From Baseline in the Central Region Staining Score With Lissamine Green in the Worse Eye | Baseline | 0.85 score on a scale | Standard Deviation 0.822 |
| RESTASIS® | Change From Baseline in the Central Region Staining Score With Lissamine Green in the Worse Eye | Change from Baseline at Month 6 | -0.24 score on a scale | Standard Deviation 0.524 |
Primary
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).
Time frame: Baseline, Month 6
Population: ITT population included all enrolled participants who received at least one dose of the study drug. n in the category is the number of participants with data available at the given time-point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| RESTASIS® | Change From Baseline in the Total Conjunctival Staining Score With Fluorescein in the Worse Eye | Baseline | 4.57 score on a scale | Standard Deviation 1.237 |
| RESTASIS® | Change From Baseline in the Total Conjunctival Staining Score With Fluorescein in the Worse Eye | Change from Baseline at Month 6 | -0.61 score on a scale | Standard Deviation 1.238 |
Primary
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).
Time frame: Baseline, Month 6
Population: ITT population included all enrolled participants who received at least one dose of the study drug. n in the category is the number of participants with data available at the given time-point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| RESTASIS® | Change From Baseline in the Total Conjunctival Staining Score With Lissamine Green in the Worse Eye | Baseline | 3.99 score on a scale | Standard Deviation 1.486 |
| RESTASIS® | Change From Baseline in the Total Conjunctival Staining Score With Lissamine Green in the Worse Eye | Change from Baseline at Month 6 | -0.18 score on a scale | Standard Deviation 1.235 |
Primary
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).
Time frame: Baseline, Month 6
Population: ITT population included all enrolled participants who received at least one dose of the study drug. n in the category is the number of participants with data available at the given time-point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| RESTASIS® | Change From Baseline in the Total Corneal Staining Score With Fluorescein in the Worse Eye | Baseline | 7.05 score on a scale | Standard Deviation 1.011 |
| RESTASIS® | Change From Baseline in the Total Corneal Staining Score With Fluorescein in the Worse Eye | Change from Baseline at Month 6 | -1.51 score on a scale | Standard Deviation 1.466 |
Primary
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).
Time frame: Baseline, Month 6
Population: ITT population included all enrolled participants who received at least one dose of the study drug. n in the category is the number of participants with data available at the given time-point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| RESTASIS® | Change From Baseline in the Total Corneal Staining Score With Lissamine Green in the Worse Eye | Baseline | 4.00 score on a scale | Standard Deviation 1.378 |
| RESTASIS® | Change From Baseline in the Total Corneal Staining Score With Lissamine Green in the Worse Eye | Change from Baseline at Month 6 | -0.34 score on a scale | Standard Deviation 1.418 |
Primary
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).
Time frame: Baseline, Month 6
Population: ITT population was defined as all enrolled participants who received at least one dose of study drug. n in the category is the number of participants with data available at the given time-point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| RESTASIS® | Change From Baseline in Time to Read Passage | Baseline | 126.0 seconds | Standard Deviation 28.64 |
| RESTASIS® | Change From Baseline in Time to Read Passage | Change from Baseline at Month 6 | -0.7 seconds | Standard Deviation 24.48 |
Primary
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.
Time frame: Baseline, Month 6
Population: ITT population was defined as all enrolled participants who received at least one dose of study drug. n in the category is the number of participants with data available at the given time-point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| RESTASIS® | Change From Baseline in Words Read Incorrectly | Baseline | 16.6 incorrect words | Standard Deviation 22 |
| RESTASIS® | Change From Baseline in Words Read Incorrectly | Change from Baseline at Month 6 | -4.1 incorrect words | Standard Deviation 16.64 |
Secondary
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.
Time frame: Baseline, Month 6
Population: ITT population included all enrolled participants who received at least one dose of study drug. n in the category is the number of participants with data available at the given time-point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| RESTASIS® | Change From Baseline in Blurred Vision on the OSDI© | Baseline | 1.7 score on a scale | Standard Deviation 1.18 |
| RESTASIS® | Change From Baseline in Blurred Vision on the OSDI© | Change from Baseline at Month 6 | -0.6 score on a scale | Standard Deviation 0.86 |
Secondary
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.
Time frame: Baseline, Month 6
Population: Participants from the ITT population, all enrolled participants who received at least one dose of study drug with data available for analysis. n in the category is the number of participants with data available at the given time-point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| RESTASIS® | Change From Baseline in Driving at Night on the OSDI© | Baseline | 1.7 score on a scale | Standard Deviation 1.3 |
| RESTASIS® | Change From Baseline in Driving at Night on the OSDI© | Change from Baseline at Month 6 | -0.5 score on a scale | Standard Deviation 1.14 |
Secondary
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.
Time frame: Baseline, Month 6
Population: ITT population included all enrolled participants who received at least 1 dose of study drug. n in the category is the number of participants with data available at the given time-point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| RESTASIS® | Change From Baseline in Interblink Interval (IBI) in the Worst Eye | Baseline | 5.27 seconds | Standard Deviation 6.052 |
| RESTASIS® | Change From Baseline in Interblink Interval (IBI) in the Worst Eye | Change from Baseline at Month 6 | -1.16 seconds | Standard Deviation 6.399 |
Secondary
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.
Time frame: Baseline, Month 6
Population: Participants from the ITT population, all enrolled participants who received at least one dose of study drug with data available for analysis. n in the category is the number of participants with data available at the given time-point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| RESTASIS® | Change From Baseline in Ocular Protection Index (OPI) 2.0 in the Worse Eye | Baseline | 1.38 percent of area | Standard Deviation 2.064 |
| RESTASIS® | Change From Baseline in Ocular Protection Index (OPI) 2.0 in the Worse Eye | Change from Baseline at Month 6 | -0.87 percent of area | Standard Deviation 1.975 |
Secondary
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.
Time frame: Baseline, Month 6
Population: ITT population included all enrolled participants who received at least one dose of study drug. n in the category is the number of participants with data available at the given time-point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| RESTASIS® | Change From Baseline in OSDI© Total Score | Baseline | 45.1 score on a scale | Standard Deviation 17.76 |
| RESTASIS® | Change From Baseline in OSDI© Total Score | Change from Baseline at Month 6 | -14.9 score on a scale | Standard Deviation 16.5 |
Secondary
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.
Time frame: Baseline, Month 6
Population: ITT population included all enrolled participants who received at least one dose of study drug. n in the category is the number of participants with data available at the given time-point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| RESTASIS® | Change From Baseline in Poor Vision on the OSDI© | Baseline | 1.5 score on a scale | Standard Deviation 1.23 |
| RESTASIS® | Change From Baseline in Poor Vision on the OSDI© | Change from Baseline at Month 6 | -0.5 score on a scale | Standard Deviation 0.84 |
Secondary
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.
Time frame: Baseline, Month 6
Population: ITT population included all enrolled participants who received at least one dose of study drug. n in the category is the number of participants with data available at the given time-point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| RESTASIS® | Change From Baseline in Reading on the OSDI© | Baseline | 1.5 score on a scale | Standard Deviation 1.25 |
| RESTASIS® | Change From Baseline in Reading on the OSDI© | Change from Baseline at Month 6 | -0.3 score on a scale | Standard Deviation 1.15 |
Secondary
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.
Time frame: Baseline, Month 6
Population: ITT population included all enrolled participants who received at least one dose of study drug. n in the category is the number of participants with data available at the given time-point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| RESTASIS® | Change From Baseline in Tear Film Break Up Time (TFBUT) in the Worse Eye | Baseline | 2.38 seconds | Standard Deviation 1.073 |
| RESTASIS® | Change From Baseline in Tear Film Break Up Time (TFBUT) in the Worse Eye | Change from Baseline at Month 6 | -0.31 seconds | Standard Deviation 1.258 |
Secondary
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.
Time frame: Baseline, Month 6
Population: Participant from the ITT population, all enrolled participants who received at least one dose of study drug, with data available for analysis. n in the category is the number of participants with data available at the given time-point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| RESTASIS® | Change From Baseline in the Ocular Discomfort Scale Post Wilkins Test in the Worst Eye | Baseline | 3.08 score on a scale | Standard Deviation 1.017 |
| RESTASIS® | Change From Baseline in the Ocular Discomfort Scale Post Wilkins Test in the Worst Eye | Change from Baseline at Month 6 | -0.60 score on a scale | Standard Deviation 1.232 |
Secondary
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.
Time frame: Baseline, Month 6
Population: Participants from the ITT population, all enrolled participants who received at least one dose of study drug with data available for analysis. n in the category is the number of participants with data available at the given time-point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| RESTASIS® | Change From Baseline in Watching Television (TV) on the OSDI© | Baseline | 1.8 score on a scale | Standard Deviation 1.11 |
| RESTASIS® | Change From Baseline in Watching Television (TV) on the OSDI© | Change from Baseline at Month 6 | -0.9 score on a scale | Standard Deviation 1.12 |
Secondary
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.
Time frame: Baseline, Month 6
Population: Participants from the ITT population, all enrolled participants who received at least one dose of study drug with data available for analysis. n in the category is the number of participants with data available at the given time-point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| RESTASIS® | Change From Baseline in Working With a Computer or Bank Machine on the OSDI© | Baseline | 1.9 score on a scale | Standard Deviation 1.03 |
| RESTASIS® | Change From Baseline in Working With a Computer or Bank Machine on the OSDI© | Change from Baseline at Month 6 | -0.8 score on a scale | Standard Deviation 1.08 |