Dry Eye Syndromes
Conditions
Brief summary
This study will evaluate the safety and efficacy of cyclosporine 0.05% ophthalmic emulsion (Restasis®) in patients with dry eye disease.
Interventions
Cyclosporine 0.05% ophthalmic emulsion (Restasis®) eye drops administered twice daily for 6 months.
DRUGcarboxymethylcellulose-based lubricant eye drops
Carboxymethylcellulose-based lubricant eye drops (Refresh OPTIVE® Advanced) administered as needed for 6 months.
Sponsors
Allergan
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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 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 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 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 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 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 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 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 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 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. |
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 40 |
| Total | 40 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Administrative Reasons | 1 |
| Overall Study | Adverse Event | 2 |
Baseline characteristics
| Characteristic | Cyclosporine 0.05% Ophthalmic Emulsion |
|---|---|
| Age, Continuous | 59.4 Years STANDARD_DEVIATION 9.05 |
| Sex: Female, Male Female | 35 Participants |
| Sex: Female, Male Male | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 12 / 40 |
| serious Total, serious adverse events | 2 / 40 |
Outcome results
Primary
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.
Time frame: Baseline, Month 6
Population: Intent-to-Treat: all enrolled patients who received at least one dose of the study drug and who have data for this outcome measure
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cyclosporine 0.05% Ophthalmic Emulsion | Change From Baseline in Driving at Night on the OSDI | Baseline | 2.3 Scores on a Scale | Standard Deviation 1.46 |
| Cyclosporine 0.05% Ophthalmic Emulsion | Change From Baseline in Driving at Night on the OSDI | Change from Baseline at Month 6 (N=28) | -0.5 Scores on a Scale | Standard Deviation 1.32 |
Primary
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.
Time frame: Baseline, Month 6
Population: Intent-to-Treat: all enrolled patients who received at least one dose of the study drug
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cyclosporine 0.05% Ophthalmic Emulsion | Change From Baseline in Font Size | Baseline | 12.0 Size | Standard Deviation 0 |
| Cyclosporine 0.05% Ophthalmic Emulsion | Change From Baseline in Font Size | Change from Baseline at Month 6 (N=37) | -0.2 Size | Standard Deviation 0.75 |
Primary
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.
Time frame: Baseline, Month 6
Population: Intent-to-Treat: all enrolled patients who received at least one dose of the study drug
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cyclosporine 0.05% Ophthalmic Emulsion | Change From Baseline in Reading on the Ocular Surface Disease Index (OSDI) | Baseline | 1.4 Scores on a Scale | Standard Deviation 1.11 |
| Cyclosporine 0.05% Ophthalmic Emulsion | Change From Baseline in Reading on the Ocular Surface Disease Index (OSDI) | Change from Baseline at Month 6 (N=36) | -0.7 Scores on a Scale | Standard Deviation 1.07 |
Primary
Change From Baseline in Reading Rate
Reading speed is assessed as the number of words read correctly in 2 minutes.
Time frame: Baseline, Month 6
Population: Intent-to-Treat: all enrolled patients who received at least one dose of the study drug
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cyclosporine 0.05% Ophthalmic Emulsion | Change From Baseline in Reading Rate | Baseline | 105.2 Words/Minute | Standard Deviation 17.11 |
| Cyclosporine 0.05% Ophthalmic Emulsion | Change From Baseline in Reading Rate | Change from Baseline at Month 6 (N=37) | 3.5 Words/Minute | Standard Deviation 11.69 |
Primary
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).
Time frame: Baseline, Month 6
Population: Intent-to-Treat: all enrolled patients who received at least one dose of the study drug
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cyclosporine 0.05% Ophthalmic Emulsion | Change From Baseline in Total Conjunctival Staining Score With Fluorescein in the Worse Eye | Baseline | 4.68 Scores on a Scale | Standard Deviation 1.035 |
| Cyclosporine 0.05% Ophthalmic Emulsion | Change From Baseline in Total Conjunctival Staining Score With Fluorescein in the Worse Eye | Change from Baseline at Month 6 (N=37) | 0.11 Scores on a Scale | Standard Deviation 1.162 |
Primary
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).
Time frame: Baseline, Month 6
Population: Intent-to-Treat: all enrolled patients who received at least one dose of the study drug
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cyclosporine 0.05% Ophthalmic Emulsion | Change From Baseline in Total Conjunctival Staining Score With Lissamine Green in the Worse Eye | Baseline | 4.21 Scores on a Scale | Standard Deviation 1.255 |
| Cyclosporine 0.05% Ophthalmic Emulsion | Change From Baseline in Total Conjunctival Staining Score With Lissamine Green in the Worse Eye | Change from Baseline at Month 6 (N=37) | 0.30 Scores on a Scale | Standard Deviation 1.356 |
Primary
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).
Time frame: Baseline, Month 6
Population: Intent-to-Treat: all enrolled patients who received at least one dose of the study drug
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cyclosporine 0.05% Ophthalmic Emulsion | Change From Baseline in Total Corneal Staining Score With Fluorescein in the Worse Eye | Baseline | 7.29 Scores on a Scale | Standard Deviation 1.409 |
| Cyclosporine 0.05% Ophthalmic Emulsion | Change From Baseline in Total Corneal Staining Score With Fluorescein in the Worse Eye | Change from Baseline at Month 6 (N=37) | -1.96 Scores on a Scale | Standard Deviation 1.677 |
Primary
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).
Time frame: Baseline, Month 6
Population: Intent-to-Treat: all enrolled patients who received at least one dose of the study drug
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cyclosporine 0.05% Ophthalmic Emulsion | Change From Baseline in Total Corneal Staining Score With Lissamine Green in the Worse Eye | Baseline | 4.43 Scores on a Scale | Standard Deviation 1.389 |
| Cyclosporine 0.05% Ophthalmic Emulsion | Change From Baseline in Total Corneal Staining Score With Lissamine Green in the Worse Eye | Change from Baseline at Month 6 (N=37) | -0.93 Scores on a Scale | Standard Deviation 1.439 |
Primary
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.
Time frame: Baseline, Month 6
Population: Intent-to-Treat: all enrolled patients who received at least one dose of the study drug and who have data for this outcome measure
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cyclosporine 0.05% Ophthalmic Emulsion | Change From Baseline in Watching TV on the OSDI | Baseline | 1.7 Scores on a Scale | Standard Deviation 1.04 |
| Cyclosporine 0.05% Ophthalmic Emulsion | Change From Baseline in Watching TV on the OSDI | Change from Baseline at Month 6 (N=32) | -0.8 Scores on a Scale | Standard Deviation 1.04 |
Primary
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.
Time frame: Baseline, Month 6
Population: Intent-to-Treat: all enrolled patients who received at least one dose of the study drug
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cyclosporine 0.05% Ophthalmic Emulsion | Change From Baseline in Words Read Incorrectly | Baseline | 0.4 Words | Standard Deviation 0.64 |
| Cyclosporine 0.05% Ophthalmic Emulsion | Change From Baseline in Words Read Incorrectly | Change from Baseline at Month 6 (N=37) | 0.2 Words | Standard Deviation 0.9 |
Primary
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.
Time frame: Baseline, Month 6
Population: Intent-to-Treat: all enrolled patients who received at least one dose of the study drug and who have data for this outcome measure
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cyclosporine 0.05% Ophthalmic Emulsion | Change From Baseline in Working With a Computer or Bank Machine on the OSDI | Baseline | 2.2 Scores on a Scale | Standard Deviation 1.1 |
| Cyclosporine 0.05% Ophthalmic Emulsion | Change From Baseline in Working With a Computer or Bank Machine on the OSDI | Change from Baseline at Month 6 (N=34) | -1.0 Scores on a Scale | Standard Deviation 1.06 |
Secondary
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.
Time frame: Baseline, Month 6
Population: Intent-to-Treat: all enrolled patients who received at least one dose of the study drug
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cyclosporine 0.05% Ophthalmic Emulsion | Change From Baseline in Conjunctival Redness in the Worse Eye | Baseline | 2.06 Scores on a Scale | Standard Deviation 0.709 |
| Cyclosporine 0.05% Ophthalmic Emulsion | Change From Baseline in Conjunctival Redness in the Worse Eye | Change from Baseline at Month 6 (N=37) | -0.03 Scores on a Scale | Standard Deviation 0.707 |
Secondary
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.
Time frame: Baseline, Month 6
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cyclosporine 0.05% Ophthalmic Emulsion | Change From Baseline in Ocular Discomfort on a 4-point Scale | Baseline | 2.85 Scores on a Scale | Standard Deviation 0.921 |
| Cyclosporine 0.05% Ophthalmic Emulsion | Change From Baseline in Ocular Discomfort on a 4-point Scale | Change from Baseline at Month 6 (N=37) | -1.30 Scores on a Scale | Standard Deviation 1.266 |
Secondary
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.
Time frame: Baseline, Month 6
Population: Intent-to-Treat: all enrolled patients who received at least one dose of the study drug
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cyclosporine 0.05% Ophthalmic Emulsion | Change From Baseline in OSDI | Baseline | 47.0 Scores on a Scale | Standard Deviation 16.97 |
| Cyclosporine 0.05% Ophthalmic Emulsion | Change From Baseline in OSDI | Change from Baseline at Month 6 (N=37) | -19.7 Scores on a Scale | Standard Deviation 14.43 |
Secondary
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.
Time frame: Baseline, Month 6
Population: Intent-to-Treat: all enrolled patients who received at least one dose of the study drug
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cyclosporine 0.05% Ophthalmic Emulsion | Change From Baseline in Tear Film Break-up Time in the Worse Eye | Baseline | 1.55 Seconds | Standard Deviation 0.428 |
| Cyclosporine 0.05% Ophthalmic Emulsion | Change From Baseline in Tear Film Break-up Time in the Worse Eye | Change from Baseline (N=37) | 0.92 Seconds | Standard Deviation 1.044 |
Secondary
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.
Time frame: Baseline, Month 6
Population: Intent-to-Treat: all enrolled patients who received at least one dose of the study drug
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cyclosporine 0.05% Ophthalmic Emulsion | Change From Baseline in the Interblink Interval in the Worse Eye | Change from Baseline at Month 6 (N=35) | 3.04 Seconds | Standard Deviation 10.637 |
| Cyclosporine 0.05% Ophthalmic Emulsion | Change From Baseline in the Interblink Interval in the Worse Eye | Baseline | 4.18 Seconds | Standard Deviation 3.233 |