IMPACT: Investigation of Maintaining Visual Performance Achieved With Cyclosporine Therapy

• Sponsor: Allergan (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02121847
• Collaborator: (none)
• Enrollment: 40
• Location: 1
• Arm: 1
• Actual Duration (Months): 5.7
• Patients Per Site Per Month: 7

Study Details

Study Description

Brief Summary

This study will evaluate the safety and efficacy of cyclosporine 0.05% ophthalmic emulsion (Restasis®) in patients with dry eye disease.

Condition or Disease	Intervention/Treatment	Phase
Dry Eye Syndromes	Drug: cyclosporine 0.05% ophthalmic emulsion; Drug: carboxymethylcellulose-based lubricant eye drops	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 40 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Actual Study Start Date: Apr 3, 2014
• Actual Primary Completion Date: Sep 23, 2014
• Actual Study Completion Date: Sep 23, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Drug: cyclosporine 0.05% ophthalmic emulsion; Cyclosporine 0.05% ophthalmic emulsion (Restasis®) eye drops administered twice daily for 6 months.; Other Names: Restasis® ; Drug: carboxymethylcellulose-based lubricant eye drops; Carboxymethylcellulose-based lubricant eye drops (Refresh OPTIVE® Advanced) administered as needed for 6 months.; Other Names: Refresh OPTIVE® Advanced

Outcome Measures

Primary Outcome Measures

1. 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).

2. 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).

3. 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).

4. 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).

5. 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.

6. 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.

7. 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.

8. 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.

9. Change From Baseline in Reading Rate [Baseline, Month 6]

   Reading speed is assessed as the number of words read correctly in 2 minutes.

10. 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.

11. 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

1. 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.

2. 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.

3. 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.

4. 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.

5. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Andover	Massachusetts	United States

Sponsors and Collaborators

• Allergan

Investigators

• Study Director: Medical Director, Allergan

Study Documents (Full-Text)

None provided.

More Information

Publications

• Stonecipher KG, Torkildsen GL, Ousler GW 3rd, Morris S, Villanueva L, Hollander DA. The IMPACT study: a prospective evaluation of the effects of cyclosporine ophthalmic emulsion 0.05% on ocular surface staining and visual performance in patients with dry eye. Clin Ophthalmol. 2016 May 13;10:887-95. doi: 10.2147/OPTH.S101627. eCollection 2016.

• Responsible Party: Allergan
• ClinicalTrials.gov Identifier: NCT02121847
• Other Study ID Numbers: GMA-RES-014-001
• First Posted: Apr 24, 2014
• Last Update Posted: Apr 18, 2019
• Last Verified: Apr 1, 2019

• Additional relevant MeSH terms: Dry Eye Syndromes; Cyclosporine; Carboxymethylcellulose Sodium; Ophthalmic Solutions; Lubricant Eye Drops; Cyclosporins

Study Results

Participant Flow

Arm/Group Title	Cyclosporine 0.05% Ophthalmic Emulsion
Arm/Group Description	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.
Period Title: Overall Study
STARTED	40
COMPLETED	37
NOT COMPLETED	3

Baseline Characteristics

Arm/Group Title	Cyclosporine 0.05% Ophthalmic Emulsion
Arm/Group Description	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.
Overall Participants	40
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	59.4 (9.05)
Sex: Female, Male (Count of Participants)
Female	35 87.5%
Male	5 12.5%

Outcome Measures

1. Primary Outcome

Title	Change From Baseline in Total Corneal Staining Score With Fluorescein in the Worse Eye
Description	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

Outcome Measure Data

Analysis Population Description

Intent-to-Treat: all enrolled patients who received at least one dose of the study drug

Arm/Group Title	Cyclosporine 0.05% Ophthalmic Emulsion
Arm/Group Description	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.
Measure Participants	40
Baseline	7.29 (1.409)
Change from Baseline at Month 6 (N=37)	-1.96 (1.677)

2. Primary Outcome

Title	Change From Baseline in Total Conjunctival Staining Score With Fluorescein in the Worse Eye
Description	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

Outcome Measure Data

Analysis Population Description

Intent-to-Treat: all enrolled patients who received at least one dose of the study drug

Arm/Group Title	Cyclosporine 0.05% Ophthalmic Emulsion
Arm/Group Description	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.
Measure Participants	40
Baseline	4.68 (1.035)
Change from Baseline at Month 6 (N=37)	0.11 (1.162)

3. Primary Outcome

Title	Change From Baseline in Total Corneal Staining Score With Lissamine Green in the Worse Eye
Description	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

Outcome Measure Data

Analysis Population Description

Intent-to-Treat: all enrolled patients who received at least one dose of the study drug

Arm/Group Title	Cyclosporine 0.05% Ophthalmic Emulsion
Arm/Group Description	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.
Measure Participants	40
Baseline	4.43 (1.389)
Change from Baseline at Month 6 (N=37)	-0.93 (1.439)

4. Primary Outcome

Title	Change From Baseline in Total Conjunctival Staining Score With Lissamine Green in the Worse Eye
Description	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

Outcome Measure Data

Analysis Population Description

Intent-to-Treat: all enrolled patients who received at least one dose of the study drug

Arm/Group Title	Cyclosporine 0.05% Ophthalmic Emulsion
Arm/Group Description	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.
Measure Participants	40
Baseline	4.21 (1.255)
Change from Baseline at Month 6 (N=37)	0.30 (1.356)

5. Primary Outcome

Title	Change From Baseline in Reading on the Ocular Surface Disease Index (OSDI)
Description	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

Outcome Measure Data

Analysis Population Description

Intent-to-Treat: all enrolled patients who received at least one dose of the study drug

Arm/Group Title	Cyclosporine 0.05% Ophthalmic Emulsion
Arm/Group Description	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.
Measure Participants	40
Baseline	1.4 (1.11)
Change from Baseline at Month 6 (N=36)	-0.7 (1.07)

6. Primary Outcome

Title	Change From Baseline in Driving at Night on the OSDI
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	Cyclosporine 0.05% Ophthalmic Emulsion
Arm/Group Description	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.
Measure Participants	35
Baseline	2.3 (1.46)
Change from Baseline at Month 6 (N=28)	-0.5 (1.32)

7. Primary Outcome

Title	Change From Baseline in Working With a Computer or Bank Machine on the OSDI
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	Cyclosporine 0.05% Ophthalmic Emulsion
Arm/Group Description	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.
Measure Participants	38
Baseline	2.2 (1.10)
Change from Baseline at Month 6 (N=34)	-1.0 (1.06)

8. Primary Outcome

Title	Change From Baseline in Watching TV on the OSDI
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	Cyclosporine 0.05% Ophthalmic Emulsion
Arm/Group Description	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.
Measure Participants	36
Baseline	1.7 (1.04)
Change from Baseline at Month 6 (N=32)	-0.8 (1.04)

9. Primary Outcome

Title	Change From Baseline in Reading Rate
Description	Reading speed is assessed as the number of words read correctly in 2 minutes.
Time Frame	Baseline, Month 6

Outcome Measure Data

Analysis Population Description

Intent-to-Treat: all enrolled patients who received at least one dose of the study drug

Arm/Group Title	Cyclosporine 0.05% Ophthalmic Emulsion
Arm/Group Description	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.
Measure Participants	40
Baseline	105.2 (17.11)
Change from Baseline at Month 6 (N=37)	3.5 (11.69)

10. Primary Outcome

Title	Change From Baseline in Words Read Incorrectly
Description	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

Outcome Measure Data

Analysis Population Description

Intent-to-Treat: all enrolled patients who received at least one dose of the study drug

Arm/Group Title	Cyclosporine 0.05% Ophthalmic Emulsion
Arm/Group Description	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.
Measure Participants	40
Baseline	0.4 (0.64)
Change from Baseline at Month 6 (N=37)	0.2 (0.90)

11. Primary Outcome

Title	Change From Baseline in Font Size
Description	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

Outcome Measure Data

Analysis Population Description

Intent-to-Treat: all enrolled patients who received at least one dose of the study drug

Arm/Group Title	Cyclosporine 0.05% Ophthalmic Emulsion
Arm/Group Description	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.
Measure Participants	40
Baseline	12.0 (0.00)
Change from Baseline at Month 6 (N=37)	-0.2 (0.75)

12. Secondary Outcome

Title	Change From Baseline in OSDI
Description	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

Outcome Measure Data

Analysis Population Description

Intent-to-Treat: all enrolled patients who received at least one dose of the study drug

Arm/Group Title	Cyclosporine 0.05% Ophthalmic Emulsion
Arm/Group Description	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.
Measure Participants	40
Baseline	47.0 (16.97)
Change from Baseline at Month 6 (N=37)	-19.7 (14.43)

13. Secondary Outcome

Title	Change From Baseline in Ocular Discomfort on a 4-point Scale
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Cyclosporine 0.05% Ophthalmic Emulsion
Arm/Group Description	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.
Measure Participants	40
Baseline	2.85 (0.921)
Change from Baseline at Month 6 (N=37)	-1.30 (1.266)

14. Secondary Outcome

Title	Change From Baseline in Tear Film Break-up Time in the Worse Eye
Description	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

Outcome Measure Data

Analysis Population Description

Intent-to-Treat: all enrolled patients who received at least one dose of the study drug

Arm/Group Title	Cyclosporine 0.05% Ophthalmic Emulsion
Arm/Group Description	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.
Measure Participants	40
Baseline	1.55 (0.428)
Change from Baseline (N=37)	0.92 (1.044)

15. Secondary Outcome

Title	Change From Baseline in the Interblink Interval in the Worse Eye
Description	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

Outcome Measure Data

Analysis Population Description

Intent-to-Treat: all enrolled patients who received at least one dose of the study drug

Arm/Group Title	Cyclosporine 0.05% Ophthalmic Emulsion
Arm/Group Description	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.
Measure Participants	40
Baseline	4.18 (3.233)
Change from Baseline at Month 6 (N=35)	3.04 (10.637)

16. Secondary Outcome

Title	Change From Baseline in Conjunctival Redness in the Worse Eye
Description	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

Outcome Measure Data

Analysis Population Description

Intent-to-Treat: all enrolled patients who received at least one dose of the study drug

Arm/Group Title	Cyclosporine 0.05% Ophthalmic Emulsion
Arm/Group Description	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.
Measure Participants	40
Baseline	2.06 (0.709)
Change from Baseline at Month 6 (N=37)	-0.03 (0.707)

Adverse Events

Arm/Group Title	Cyclosporine 0.05% Ophthalmic Emulsion
Arm/Group Description	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.
All Cause Mortality
	Cyclosporine 0.05% Ophthalmic Emulsion
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Cyclosporine 0.05% Ophthalmic Emulsion
	Affected / at Risk (%)	# Events
Total	2/40 (5%)
Nervous system disorders
Transient Ischaemic Attack	1/40 (2.5%)
Renal and urinary disorders
Renal Failure Acute	1/40 (2.5%)
Respiratory, thoracic and mediastinal disorders
Pneumothorax	1/40 (2.5%)
Other (Not Including Serious) Adverse Events
	Cyclosporine 0.05% Ophthalmic Emulsion
	Affected / at Risk (%)	# Events
Total	12/40 (30%)
Eye disorders
Eye Irritation	2/40 (5%)
General disorders
Instillation Site Burn	3/40 (7.5%)
Instillation Site Pain	3/40 (7.5%)
Musculoskeletal and connective tissue disorders
Osteoarthritis	2/40 (5%)
Nervous system disorders
Headache	2/40 (5%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

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.