Trial Outcomes & Findings for Efficacy and Safety of a New Artificial Tear Formulation Compared With Systane Ultra Multidose in Participants With Dry Eye Disease (NCT NCT04393441)

Last Updated: 2024-06-26

Results Overview

The total staining score is the sum of corneal and conjunctival staining score using Modified NEI grading scale. The cornea is divided into 5 zones and the nasal and temporal conjunctiva is divided into 6 zones. The combined total staining score is based on the sum of the five zones on the cornea and six zones on the conjunctiva. Each zone is graded on a 0 to 5 scale (0=no staining; 1=trace; 2=mild; 3=moderate; 4=severe; 5=very severe), for a total score ranging from 0 to 55. The higher the score, the worse the dry eye condition. A negative change from Baseline represents a decrease in the severity of staining (improvement). The study eye is defined as the worst eye based on total ocular staining score at Baseline (Day 1). The fellow eye is the other eye. A mixed-effects model repeated measures (MMMR) was used for analyses.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

400 participants

Primary outcome timeframe

Baseline (Day 1) and Day 90

Results posted on

2024-06-26

Participant Flow

Participant milestones

Participant milestones
Measure	Systane® Ultra Multidose All participants administered 1 to 2 drops of REFRESH PLUS® 3 times daily in each eye for approximately 7 days during a run-in period prior to randomization on Day 1. Participants then administered 1 to 2 drops of Systane® Ultra Multidose in each eye 3 times daily for up to 90 days.	011516X (New Artificial Tear Formulation) All participants administered 1 to 2 drops of REFRESH PLUS® 3 times daily in each eye for approximately 7 days during a run-in period prior to randomization on Day 1. Participants then administered 1 to 2 drops of 011516X in each eye 3 times daily for up to 90 days.
Overall Study STARTED	200	200
Overall Study Safety Population	199	200
Overall Study COMPLETED	192	186
Overall Study NOT COMPLETED	8	14

Reasons for withdrawal

Reasons for withdrawal
Measure	Systane® Ultra Multidose All participants administered 1 to 2 drops of REFRESH PLUS® 3 times daily in each eye for approximately 7 days during a run-in period prior to randomization on Day 1. Participants then administered 1 to 2 drops of Systane® Ultra Multidose in each eye 3 times daily for up to 90 days.	011516X (New Artificial Tear Formulation) All participants administered 1 to 2 drops of REFRESH PLUS® 3 times daily in each eye for approximately 7 days during a run-in period prior to randomization on Day 1. Participants then administered 1 to 2 drops of 011516X in each eye 3 times daily for up to 90 days.
Overall Study Adverse Event	0	3
Overall Study Withdrawal by Subject	5	7
Overall Study Lost to Follow-up	0	2
Overall Study Protocol Deviation	2	1
Overall Study Reason not Specified	1	1

Baseline Characteristics

Efficacy and Safety of a New Artificial Tear Formulation Compared With Systane Ultra Multidose in Participants With Dry Eye Disease

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Systane® Ultra Multidose n=200 Participants All participants administered 1 to 2 drops of REFRESH PLUS® 3 times daily in each eye for approximately 7 days during a run-in period prior to randomization on Day 1. Participants then administered 1 to 2 drops of Systane® Ultra Multidose in each eye 3 times daily for up to 90 days.	011516X (New Artificial Tear Formulation) n=200 Participants All participants administered 1 to 2 drops of REFRESH PLUS® 3 times daily in each eye for approximately 7 days during a run-in period prior to randomization on Day 1. Participants then administered 1 to 2 drops of 011516X in each eye 3 times daily for up to 90 days.	Total n=400 Participants Total of all reporting groups
Age, Continuous	57.5 years STANDARD_DEVIATION 13.95 • n=5 Participants	59.3 years STANDARD_DEVIATION 13.55 • n=7 Participants	58.4 years STANDARD_DEVIATION 13.76 • n=5 Participants
Sex: Female, Male Female	166 Participants n=5 Participants	157 Participants n=7 Participants	323 Participants n=5 Participants
Sex: Female, Male Male	34 Participants n=5 Participants	43 Participants n=7 Participants	77 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	32 Participants n=5 Participants	33 Participants n=7 Participants	65 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	168 Participants n=5 Participants	167 Participants n=7 Participants	335 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	4 Participants n=5 Participants	12 Participants n=7 Participants	16 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	49 Participants n=5 Participants	30 Participants n=7 Participants	79 Participants n=5 Participants
Race (NIH/OMB) White	147 Participants n=5 Participants	157 Participants n=7 Participants	304 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Total Staining Score in the Study Eye	13.4 score on a scale n=5 Participants	12.8 score on a scale n=7 Participants	13.1 score on a scale n=5 Participants

PRIMARY outcome

Timeframe: Baseline (Day 1) and Day 90

Population: ITT population consisted of all randomized participants. Overall number analyzed are the number of participants with data available for analyses at the given time point.

Outcome measures

Outcome measures
Measure	Systane® Ultra Multidose n=192 eyes All participants administered 1 to 2 drops of REFRESH PLUS® 3 times daily in each eye for approximately 7 days during a run-in period prior to randomization on Day 1. Participants then administered 1 to 2 drops of Systane® Ultra Multidose in each eye 3 times daily for up to 90 days.	011516X (New Artificial Tear Formulation) n=186 eyes All participants administered 1 to 2 drops of REFRESH PLUS® 3 times daily in each eye for approximately 7 days during a run-in period prior to randomization on Day 1. Participants then administered 1 to 2 drops of 011516X in each eye 3 times daily for up to 90 days.
Change From Baseline in Total Staining Score at Day 90 in the Study Eye	-4.5 score on a scale Standard Error 0.40	-3.4 score on a scale Standard Error 0.41

SECONDARY outcome

Timeframe: Baseline (Day 1) and Day 90

Population: ITT population consisted of all randomized participants. Overall number analyzed are the number of participants with data available for analyses at the given time point.

The Current Symptom Survey is a self-assessed 6-item visual analog scale (VAS) survey that assesses symptoms of dry eye disease (DED) including: burning, dryness, irritation, grittiness/foreign body sensation, blurry/fluctuating vision, overall ocular pain/discomfort. Each individual symptom is rated using a score range of 0=none to 100=maximum. The total score, ranging from 0 to 600, is calculated as the sum of individual symptom scores. A negative change from Baseline indicates improvement in DED symptoms experienced by the participant. This is an overall evaluation not per eye. A MMMR model was used for analyses.

Outcome measures

Outcome measures
Measure	Systane® Ultra Multidose n=192 Participants All participants administered 1 to 2 drops of REFRESH PLUS® 3 times daily in each eye for approximately 7 days during a run-in period prior to randomization on Day 1. Participants then administered 1 to 2 drops of Systane® Ultra Multidose in each eye 3 times daily for up to 90 days.	011516X (New Artificial Tear Formulation) n=186 Participants All participants administered 1 to 2 drops of REFRESH PLUS® 3 times daily in each eye for approximately 7 days during a run-in period prior to randomization on Day 1. Participants then administered 1 to 2 drops of 011516X in each eye 3 times daily for up to 90 days.
Change From Baseline in Current Symptom Survey Total Score at Day 90	-138.5 score on a scale Standard Error 11.46	-136.5 score on a scale Standard Error 11.62

Adverse Events

Systane® Ultra Multidose

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

011516X (New Artificial Tear Formulation)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Systane® Ultra Multidose n=199 participants at risk All participants administered 1 to 2 drops of REFRESH PLUS® 3 times daily in each eye for approximately 7 days during a run-in period prior to randomization on Day 1. Participants then administered 1 to 2 drops of Systane® Ultra Multidose in each eye 3 times daily for up to 90 days.	011516X (New Artificial Tear Formulation) n=200 participants at risk All participants administered 1 to 2 drops of REFRESH PLUS® 3 times daily in each eye for approximately 7 days during a run-in period prior to randomization on Day 1. Participants then administered 1 to 2 drops of 011516X in each eye 3 times daily for up to 90 days.
Infections and infestations PNEUMONIA	0.50% 1/199 • Number of events 1 • From first dose of study drug up to 30 days post last dose (up to approximately 147 days) All-cause Mortality: ITT population consisted of all randomized participants; Serious Adverse Events and Other Adverse Events: Safety Population consisted of all treated participants who received/took ≥1 administration of study intervention.	0.00% 0/200 • From first dose of study drug up to 30 days post last dose (up to approximately 147 days) All-cause Mortality: ITT population consisted of all randomized participants; Serious Adverse Events and Other Adverse Events: Safety Population consisted of all treated participants who received/took ≥1 administration of study intervention.
Respiratory, thoracic and mediastinal disorders ACUTE RESPIRATORY FAILURE	0.50% 1/199 • Number of events 1 • From first dose of study drug up to 30 days post last dose (up to approximately 147 days) All-cause Mortality: ITT population consisted of all randomized participants; Serious Adverse Events and Other Adverse Events: Safety Population consisted of all treated participants who received/took ≥1 administration of study intervention.	0.00% 0/200 • From first dose of study drug up to 30 days post last dose (up to approximately 147 days) All-cause Mortality: ITT population consisted of all randomized participants; Serious Adverse Events and Other Adverse Events: Safety Population consisted of all treated participants who received/took ≥1 administration of study intervention.

Other adverse events

Adverse event data not reported

Additional Information

Global Medical Services

AbbVie

Phone: 800-633-9110

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.
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