Trial Outcomes & Findings for Investigation of Maintaining Visual Performance Achieved With Cyclosporine Therapy (NCT NCT02121847)
NCT ID: NCT02121847
Last Updated: 2019-04-18
Results Overview
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).
COMPLETED
PHASE4
40 participants
Baseline, Month 6
2019-04-18
Participant Flow
Participant milestones
| Measure |
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.
|
|---|---|
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Overall Study
STARTED
|
40
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Overall Study
COMPLETED
|
37
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
| Measure |
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.
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|---|---|
|
Overall Study
Administrative Reasons
|
1
|
|
Overall Study
Adverse Event
|
2
|
Baseline Characteristics
Investigation of Maintaining Visual Performance Achieved With Cyclosporine Therapy
Baseline characteristics by cohort
| Measure |
Cyclosporine 0.05% Ophthalmic Emulsion
n=40 Participants
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.
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|---|---|
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Age, Continuous
|
59.4 Years
STANDARD_DEVIATION 9.05 • n=5 Participants
|
|
Sex: Female, Male
Female
|
35 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, Month 6Population: Intent-to-Treat: all enrolled patients who received at least one dose of the study drug
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).
Outcome measures
| Measure |
Cyclosporine 0.05% Ophthalmic Emulsion
n=40 Participants
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.
|
|---|---|
|
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
|
|
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 outcome
Timeframe: Baseline, Month 6Population: Intent-to-Treat: all enrolled patients who received at least one dose of the study drug
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).
Outcome measures
| Measure |
Cyclosporine 0.05% Ophthalmic Emulsion
n=40 Participants
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.
|
|---|---|
|
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
|
|
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 outcome
Timeframe: Baseline, Month 6Population: Intent-to-Treat: all enrolled patients who received at least one dose of the study drug
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).
Outcome measures
| Measure |
Cyclosporine 0.05% Ophthalmic Emulsion
n=40 Participants
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.
|
|---|---|
|
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
|
|
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 outcome
Timeframe: Baseline, Month 6Population: Intent-to-Treat: all enrolled patients who received at least one dose of the study drug
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).
Outcome measures
| Measure |
Cyclosporine 0.05% Ophthalmic Emulsion
n=40 Participants
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.
|
|---|---|
|
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
|
|
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 outcome
Timeframe: Baseline, Month 6Population: Intent-to-Treat: all enrolled patients who received at least one dose of the study drug
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.
Outcome measures
| Measure |
Cyclosporine 0.05% Ophthalmic Emulsion
n=40 Participants
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.
|
|---|---|
|
Change From Baseline in Reading on the Ocular Surface Disease Index (OSDI)
Baseline
|
1.4 Scores on a Scale
Standard Deviation 1.11
|
|
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 outcome
Timeframe: Baseline, Month 6Population: Intent-to-Treat: all enrolled patients who received at least one dose of the study drug and who have data for this outcome measure
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.
Outcome measures
| Measure |
Cyclosporine 0.05% Ophthalmic Emulsion
n=35 Participants
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.
|
|---|---|
|
Change From Baseline in Driving at Night on the OSDI
Baseline
|
2.3 Scores on a Scale
Standard Deviation 1.46
|
|
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 outcome
Timeframe: Baseline, Month 6Population: Intent-to-Treat: all enrolled patients who received at least one dose of the study drug and who have data for this outcome measure
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.
Outcome measures
| Measure |
Cyclosporine 0.05% Ophthalmic Emulsion
n=38 Participants
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.
|
|---|---|
|
Change From Baseline in Working With a Computer or Bank Machine on the OSDI
Baseline
|
2.2 Scores on a Scale
Standard Deviation 1.10
|
|
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
|
PRIMARY outcome
Timeframe: Baseline, Month 6Population: Intent-to-Treat: all enrolled patients who received at least one dose of the study drug and who have data for this outcome measure
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.
Outcome measures
| Measure |
Cyclosporine 0.05% Ophthalmic Emulsion
n=36 Participants
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.
|
|---|---|
|
Change From Baseline in Watching TV on the OSDI
Baseline
|
1.7 Scores on a Scale
Standard Deviation 1.04
|
|
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 outcome
Timeframe: Baseline, Month 6Population: Intent-to-Treat: all enrolled patients who received at least one dose of the study drug
Reading speed is assessed as the number of words read correctly in 2 minutes.
Outcome measures
| Measure |
Cyclosporine 0.05% Ophthalmic Emulsion
n=40 Participants
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.
|
|---|---|
|
Change From Baseline in Reading Rate
Baseline
|
105.2 Words/Minute
Standard Deviation 17.11
|
|
Change From Baseline in Reading Rate
Change from Baseline at Month 6 (N=37)
|
3.5 Words/Minute
Standard Deviation 11.69
|
PRIMARY outcome
Timeframe: Baseline, Month 6Population: Intent-to-Treat: all enrolled patients who received at least one dose of the study drug
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.
Outcome measures
| Measure |
Cyclosporine 0.05% Ophthalmic Emulsion
n=40 Participants
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.
|
|---|---|
|
Change From Baseline in Words Read Incorrectly
Baseline
|
0.4 Words
Standard Deviation 0.64
|
|
Change From Baseline in Words Read Incorrectly
Change from Baseline at Month 6 (N=37)
|
0.2 Words
Standard Deviation 0.90
|
PRIMARY outcome
Timeframe: Baseline, Month 6Population: Intent-to-Treat: all enrolled patients who received at least one dose of the study drug
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.
Outcome measures
| Measure |
Cyclosporine 0.05% Ophthalmic Emulsion
n=40 Participants
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.
|
|---|---|
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Change From Baseline in Font Size
Baseline
|
12.0 Size
Standard Deviation 0.00
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|
Change From Baseline in Font Size
Change from Baseline at Month 6 (N=37)
|
-0.2 Size
Standard Deviation 0.75
|
SECONDARY outcome
Timeframe: Baseline, Month 6Population: Intent-to-Treat: all enrolled patients who received at least one dose of the study drug
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.
Outcome measures
| Measure |
Cyclosporine 0.05% Ophthalmic Emulsion
n=40 Participants
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.
|
|---|---|
|
Change From Baseline in OSDI
Baseline
|
47.0 Scores on a Scale
Standard Deviation 16.97
|
|
Change From Baseline in OSDI
Change from Baseline at Month 6 (N=37)
|
-19.7 Scores on a Scale
Standard Deviation 14.43
|
SECONDARY outcome
Timeframe: Baseline, Month 6Ocular 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.
Outcome measures
| Measure |
Cyclosporine 0.05% Ophthalmic Emulsion
n=40 Participants
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.
|
|---|---|
|
Change From Baseline in Ocular Discomfort on a 4-point Scale
Baseline
|
2.85 Scores on a Scale
Standard Deviation 0.921
|
|
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 outcome
Timeframe: Baseline, Month 6Population: Intent-to-Treat: all enrolled patients who received at least one dose of the study drug
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.
Outcome measures
| Measure |
Cyclosporine 0.05% Ophthalmic Emulsion
n=40 Participants
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.
|
|---|---|
|
Change From Baseline in Tear Film Break-up Time in the Worse Eye
Baseline
|
1.55 Seconds
Standard Deviation 0.428
|
|
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 outcome
Timeframe: Baseline, Month 6Population: Intent-to-Treat: all enrolled patients who received at least one dose of the study drug
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.
Outcome measures
| Measure |
Cyclosporine 0.05% Ophthalmic Emulsion
n=40 Participants
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.
|
|---|---|
|
Change From Baseline in the Interblink Interval in the Worse Eye
Baseline
|
4.18 Seconds
Standard Deviation 3.233
|
|
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
|
SECONDARY outcome
Timeframe: Baseline, Month 6Population: Intent-to-Treat: all enrolled patients who received at least one dose of the study drug
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.
Outcome measures
| Measure |
Cyclosporine 0.05% Ophthalmic Emulsion
n=40 Participants
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.
|
|---|---|
|
Change From Baseline in Conjunctival Redness in the Worse Eye
Baseline
|
2.06 Scores on a Scale
Standard Deviation 0.709
|
|
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
|
Adverse Events
Cyclosporine 0.05% Ophthalmic Emulsion
Serious adverse events
| Measure |
Cyclosporine 0.05% Ophthalmic Emulsion
n=40 participants at risk
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.
|
|---|---|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
2.5%
1/40
|
|
Renal and urinary disorders
Renal Failure Acute
|
2.5%
1/40
|
|
Nervous system disorders
Transient Ischaemic Attack
|
2.5%
1/40
|
Other adverse events
| Measure |
Cyclosporine 0.05% Ophthalmic Emulsion
n=40 participants at risk
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.
|
|---|---|
|
Eye disorders
Eye Irritation
|
5.0%
2/40
|
|
General disorders
Instillation Site Burn
|
7.5%
3/40
|
|
General disorders
Instillation Site Pain
|
7.5%
3/40
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
5.0%
2/40
|
|
Nervous system disorders
Headache
|
5.0%
2/40
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
- Publication restrictions are in place
Restriction type: OTHER