Trial Outcomes & Findings for Evaluation of Maintaining Visual Performance in Participants Who Engage in Electronic Visual Tasking While Using Restasis® (NCT NCT02554981)

NCT ID: NCT02554981

Last Updated: 2017-06-01

Results Overview

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).

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 51 participants
• Primary outcome timeframe: Baseline, Month 6
• Results posted on: 2017-06-01

Participant Flow

Participant milestones

Measure	RESTASIS® 1 drop of RESTASIS® ophthalmic emulsion instilled in each eye twice a day for 6 months.
Overall Study STARTED	51
Overall Study COMPLETED	46
Overall Study NOT COMPLETED	5

Reasons for withdrawal

Measure	RESTASIS® 1 drop of RESTASIS® ophthalmic emulsion instilled in each eye twice a day for 6 months.
Overall Study Adverse Event	1
Overall Study Administrative Reasons	1
Overall Study Other Miscellaneous Reasons	3

Baseline Characteristics

Evaluation of Maintaining Visual Performance in Participants Who Engage in Electronic Visual Tasking While Using Restasis®

Baseline characteristics by cohort

Measure	RESTASIS® n=50 Participants 1 drop of RESTASIS® ophthalmic emulsion instilled in each eye twice a day for 6 months.
Age, Continuous	46.3 years STANDARD_DEVIATION 8.3 • n=5 Participants
Sex: Female, Male Female	41 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

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).

Outcome measures

Measure	RESTASIS® n=50 Participants 1 drop of RESTASIS® ophthalmic emulsion instilled in each eye twice a day for 6 months.
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
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 outcome

Timeframe: 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.

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).

Outcome measures

Measure	RESTASIS® n=50 Participants 1 drop of RESTASIS® ophthalmic emulsion instilled in each eye twice a day for 6 months.
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
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 outcome

Timeframe: 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.

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).

Outcome measures

Measure	RESTASIS® n=50 Participants 1 drop of RESTASIS® ophthalmic emulsion instilled in each eye twice a day for 6 months.
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
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 outcome

Timeframe: 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.

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).

Outcome measures

Measure	RESTASIS® n=50 Participants 1 drop of RESTASIS® ophthalmic emulsion instilled in each eye twice a day for 6 months.
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
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 outcome

Timeframe: 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.

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).

Outcome measures

Measure	RESTASIS® n=50 Participants 1 drop of RESTASIS® ophthalmic emulsion instilled in each eye twice a day for 6 months.
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
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 outcome

Timeframe: 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.

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).

Outcome measures

Measure	RESTASIS® n=50 Participants 1 drop of RESTASIS® ophthalmic emulsion instilled in each eye twice a day for 6 months.
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
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 outcome

Timeframe: 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.

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.

Outcome measures

Measure	RESTASIS® n=50 Participants 1 drop of RESTASIS® ophthalmic emulsion instilled in each eye twice a day for 6 months.
Change From Baseline in Font Size Baseline	9.0 points Standard Deviation 0.00
Change From Baseline in Font Size Change from Baseline at Month 6	0.0 points Standard Deviation 0.21

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	RESTASIS® n=50 Participants 1 drop of RESTASIS® ophthalmic emulsion instilled in each eye twice a day for 6 months.
Change From Baseline in Words Read Incorrectly Baseline	16.6 incorrect words Standard Deviation 22.00
Change From Baseline in Words Read Incorrectly Change from Baseline at Month 6	-4.1 incorrect words Standard Deviation 16.64

PRIMARY outcome

Timeframe: 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.

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).

Outcome measures

Measure	RESTASIS® n=50 Participants 1 drop of RESTASIS® ophthalmic emulsion instilled in each eye twice a day for 6 months.
Change From Baseline in Time to Read Passage Baseline	126.0 seconds Standard Deviation 28.64
Change From Baseline in Time to Read Passage Change from Baseline at Month 6	-0.7 seconds Standard Deviation 24.48

PRIMARY outcome

Timeframe: 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.

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).

Outcome measures

Measure	RESTASIS® n=50 Participants 1 drop of RESTASIS® ophthalmic emulsion instilled in each eye twice a day for 6 months.
Change From Baseline in Reading Rate Baseline	146.6 correct words/minute Standard Deviation 64.18
Change From Baseline in Reading Rate Change from Baseline at Month 6	-3.6 correct words/minute Standard Deviation 69.80

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	RESTASIS® n=50 Participants 1 drop of RESTASIS® ophthalmic emulsion instilled in each eye twice a day for 6 months.
Change From Baseline in Tear Film Break Up Time (TFBUT) in the Worse Eye Baseline	2.38 seconds Standard Deviation 1.073
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 outcome

Timeframe: 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.

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.

Outcome measures

Measure	RESTASIS® n=49 Participants 1 drop of RESTASIS® ophthalmic emulsion instilled in each eye twice a day for 6 months.
Change From Baseline in Ocular Protection Index (OPI) 2.0 in the Worse Eye Baseline	1.38 percent of area Standard Deviation 2.064
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 outcome

Timeframe: 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.

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.

Outcome measures

Measure	RESTASIS® n=49 Participants 1 drop of RESTASIS® ophthalmic emulsion instilled in each eye twice a day for 6 months.
Change From Baseline in Interblink Interval (IBI) in the Worst Eye Baseline	5.27 seconds Standard Deviation 6.052
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 outcome

Timeframe: 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.

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.

Outcome measures

Measure	RESTASIS® n=50 Participants 1 drop of RESTASIS® ophthalmic emulsion instilled in each eye twice a day for 6 months.
Change From Baseline in OSDI© Total Score Baseline	45.1 score on a scale Standard Deviation 17.76
Change From Baseline in OSDI© Total Score Change from Baseline at Month 6	-14.9 score on a scale Standard Deviation 16.50

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	RESTASIS® n=43 Participants 1 drop of RESTASIS® ophthalmic emulsion instilled in each eye twice a day for 6 months.
Change From Baseline in Driving at Night on the OSDI© Baseline	1.7 score on a scale Standard Deviation 1.30
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 outcome

Timeframe: 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.

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.

Outcome measures

Measure	RESTASIS® n=49 Participants 1 drop of RESTASIS® ophthalmic emulsion instilled in each eye twice a day for 6 months.
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
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

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	RESTASIS® n=48 Participants 1 drop of RESTASIS® ophthalmic emulsion instilled in each eye twice a day for 6 months.
Change From Baseline in Watching Television (TV) on the OSDI© Baseline	1.8 score on a scale Standard Deviation 1.11
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 outcome

Timeframe: 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.

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.

Outcome measures

Measure	RESTASIS® n=50 Participants 1 drop of RESTASIS® ophthalmic emulsion instilled in each eye twice a day for 6 months.
Change From Baseline in Blurred Vision on the OSDI© Baseline	1.7 score on a scale Standard Deviation 1.18
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 outcome

Timeframe: 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.

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.

Outcome measures

Measure	RESTASIS® n=50 Participants 1 drop of RESTASIS® ophthalmic emulsion instilled in each eye twice a day for 6 months.
Change From Baseline in Poor Vision on the OSDI© Baseline	1.5 score on a scale Standard Deviation 1.23
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 outcome

Timeframe: 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.

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.

Outcome measures

Measure	RESTASIS® n=50 Participants 1 drop of RESTASIS® ophthalmic emulsion instilled in each eye twice a day for 6 months.
Change From Baseline in Reading on the OSDI© Baseline	1.5 score on a scale Standard Deviation 1.25
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 outcome

Timeframe: 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.

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.

Outcome measures

Measure	RESTASIS® n=49 Participants 1 drop of RESTASIS® ophthalmic emulsion instilled in each eye twice a day for 6 months.
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
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

Adverse Events

RESTASIS®

Serious events: 3 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Measure	RESTASIS® n=50 participants at risk 1 drop of RESTASIS® ophthalmic emulsion instilled in each eye twice a day for 6 months.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Papillary thyroid carcinoma	2.0% 1/50
Vascular disorders Peripheral vascular disease	2.0% 1/50
Injury, poisoning and procedural complications Carbon monoxide poisoning	2.0% 1/50

Other adverse events

Measure	RESTASIS® n=50 participants at risk 1 drop of RESTASIS® ophthalmic emulsion instilled in each eye twice a day for 6 months.
Eye disorders Visual acuity reduced	6.0% 3/50
Infections and infestations Nasopharyngitis	6.0% 3/50

Additional Information

Vice President Medical Affairs,

Allergan, Inc

Phone: 714-246-4500

Email: clinicaltrials@allergan.com

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