Trial Outcomes & Findings for Clinical Evaluation of MyDay™ and 1-DAY ACUVUE® TruEye® (NCT NCT02388763)

Last Updated: 2016-12-05

Results Overview

High contrast TCVA was assessed after 3 hours exposure to reduced humidity environment. TCVA test was performed at 4 meters under high illumination (90%) using a Landolt ring test. For each acuity level, a series of single rings with gaps in one of four directions was presented and the percentage of correctly identified rings constituted the score. TCVA was measured in VA units and a higher TCVA value indicates an improvement in visual acuity. Both eyes contributed to the analysis.

Recruitment status

COMPLETED

Study phase

Target enrollment

66 participants

Primary outcome timeframe

Day 10, each product

Results posted on

2016-12-05

Participant Flow

Participants were enrolled from 1 investigative site located in the United Kingdom.

Of the 66 enrolled participants, 2 participants were discontinued prior to randomization. This reporting group includes all randomized participants (64).

Participant milestones

Participant milestones
Measure	Habitual, MyDay, 1DAVTE Habitual contact lenses worn first, followed by stenfilcon A contact lenses in Period 1 and narafilcon A contact lenses in Period 2. Each product worn bilaterally for 10 days in a daily wear, daily disposable modality.	Habitual, 1DAVTE, MyDay Habitual contact lenses worn first, followed by narafilcon A contact lenses in Period 1 and stenfilcon A contact lenses in Period 2. Each product worn bilaterally for 10 days in a daily wear, daily disposable modality.
Habitual, 10 Days of Wear STARTED	32	32
Habitual, 10 Days of Wear COMPLETED	31	31
Habitual, 10 Days of Wear NOT COMPLETED	1	1
Period 1, 10 Days of Wear STARTED	31	31
Period 1, 10 Days of Wear COMPLETED	30	30
Period 1, 10 Days of Wear NOT COMPLETED	1	1
Period 2, 10 Days of Wear STARTED	30	30
Period 2, 10 Days of Wear COMPLETED	30	30
Period 2, 10 Days of Wear NOT COMPLETED	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Habitual, MyDay, 1DAVTE Habitual contact lenses worn first, followed by stenfilcon A contact lenses in Period 1 and narafilcon A contact lenses in Period 2. Each product worn bilaterally for 10 days in a daily wear, daily disposable modality.	Habitual, 1DAVTE, MyDay Habitual contact lenses worn first, followed by narafilcon A contact lenses in Period 1 and stenfilcon A contact lenses in Period 2. Each product worn bilaterally for 10 days in a daily wear, daily disposable modality.
Habitual, 10 Days of Wear Withdrawal by Subject	1	1
Period 1, 10 Days of Wear Withdrawal by Subject	1	1

Baseline Characteristics

Clinical Evaluation of MyDay™ and 1-DAY ACUVUE® TruEye®

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Overall n=64 Participants Habitual contact lenses worn first, followed by stenfilcon A contact lenses and narafilcon A contact lenses in Periods 1 and 2 as randomized. Each product worn bilaterally for 10 days in a daily wear, daily disposable modality.
Age, Continuous	33.8 years STANDARD_DEVIATION 9.71 • n=5 Participants
Sex: Female, Male Female	45 Participants n=5 Participants
Sex: Female, Male Male	19 Participants n=5 Participants

PRIMARY outcome

Timeframe: Day 10, each product

Population: Intent to Treat

Outcome measures

Outcome measures
Measure	MyDay n=60 Participants Stenfilcon A contact lenses worn bilaterally for 10 days in a daily wear, daily disposable modality	1DAVTE n=60 Participants Narafilcon A contact lenses worn bilaterally for 10 days in a daily wear, daily disposable modality
High Contrast Time-Controlled Visual Acuity (TCVA) (VA Unit) Post-Exposure to Reduced Humidity at Day 10	0.453 VA unit Standard Deviation 0.673	0.341 VA unit Standard Deviation 0.781

SECONDARY outcome

Timeframe: Day 10, each product

Population: Intent to Treat Subjects

High contrast TCVA was assessed after 3 hours exposure to normal environment and prior to exposure to reduced humidity environment. Both eyes contributed to the analysis.

Outcome measures

Outcome measures
Measure	MyDay n=60 Participants Stenfilcon A contact lenses worn bilaterally for 10 days in a daily wear, daily disposable modality	1DAVTE n=60 Participants Narafilcon A contact lenses worn bilaterally for 10 days in a daily wear, daily disposable modality
High Contrast TCVA (VA Unit) Pre-Exposure to Reduced Humidity at Day 10	0.614 VA unit Standard Deviation 0.689	0.700 VA unit Standard Deviation 0.777

Adverse Events

Pretreatment

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Dailies Total 1

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Clariti 1-Day

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

MyDay

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

1DAVTE

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Pretreatment n=66 participants at risk All subjects who consented to participate in the study prior to the initiation of study treatment	Dailies Total 1 n=32 participants at risk Delefilcon A contact lenses per subject's habitual prescription worn for 10 days prior to Period 1	Clariti 1-Day n=32 participants at risk Somofilcon A contact lenses per subject's habitual prescription worn for 10 days prior to Period 1	MyDay n=60 participants at risk Stenfilcon A contact lenses worn for 10 days during Period 1 or 2 as randomized	1DAVTE n=61 participants at risk Narafilcon A contact lenses worn for 10 days during Period 1 or 2 as randomized
Infections and infestations Kidney infection	0.00% 0/66 • Adverse events (AEs) were collected from time of informed consent throughout the duration of a subject's participation in the study (up to 30 days). This analysis population includes all randomized participants exposed to investigational product (habitual, MyDay, and 1DAVTE) from time of product dispense (safety analysis set), based on treatment-specific exposure. One subject in the MyDay/1DAVTE arm wore habitual lenses during Period 1 and was not exposed to MyDay (discontinued at Period 1). An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the medical device. Ocular AEs are presented on the subject level, but reported by eye.	0.00% 0/32 • Adverse events (AEs) were collected from time of informed consent throughout the duration of a subject's participation in the study (up to 30 days). This analysis population includes all randomized participants exposed to investigational product (habitual, MyDay, and 1DAVTE) from time of product dispense (safety analysis set), based on treatment-specific exposure. One subject in the MyDay/1DAVTE arm wore habitual lenses during Period 1 and was not exposed to MyDay (discontinued at Period 1). An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the medical device. Ocular AEs are presented on the subject level, but reported by eye.	0.00% 0/32 • Adverse events (AEs) were collected from time of informed consent throughout the duration of a subject's participation in the study (up to 30 days). This analysis population includes all randomized participants exposed to investigational product (habitual, MyDay, and 1DAVTE) from time of product dispense (safety analysis set), based on treatment-specific exposure. One subject in the MyDay/1DAVTE arm wore habitual lenses during Period 1 and was not exposed to MyDay (discontinued at Period 1). An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the medical device. Ocular AEs are presented on the subject level, but reported by eye.	1.7% 1/60 • Adverse events (AEs) were collected from time of informed consent throughout the duration of a subject's participation in the study (up to 30 days). This analysis population includes all randomized participants exposed to investigational product (habitual, MyDay, and 1DAVTE) from time of product dispense (safety analysis set), based on treatment-specific exposure. One subject in the MyDay/1DAVTE arm wore habitual lenses during Period 1 and was not exposed to MyDay (discontinued at Period 1). An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the medical device. Ocular AEs are presented on the subject level, but reported by eye.	0.00% 0/61 • Adverse events (AEs) were collected from time of informed consent throughout the duration of a subject's participation in the study (up to 30 days). This analysis population includes all randomized participants exposed to investigational product (habitual, MyDay, and 1DAVTE) from time of product dispense (safety analysis set), based on treatment-specific exposure. One subject in the MyDay/1DAVTE arm wore habitual lenses during Period 1 and was not exposed to MyDay (discontinued at Period 1). An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the medical device. Ocular AEs are presented on the subject level, but reported by eye.
Renal and urinary disorders Renal vein thrombosis	0.00% 0/66 • Adverse events (AEs) were collected from time of informed consent throughout the duration of a subject's participation in the study (up to 30 days). This analysis population includes all randomized participants exposed to investigational product (habitual, MyDay, and 1DAVTE) from time of product dispense (safety analysis set), based on treatment-specific exposure. One subject in the MyDay/1DAVTE arm wore habitual lenses during Period 1 and was not exposed to MyDay (discontinued at Period 1). An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the medical device. Ocular AEs are presented on the subject level, but reported by eye.	0.00% 0/32 • Adverse events (AEs) were collected from time of informed consent throughout the duration of a subject's participation in the study (up to 30 days). This analysis population includes all randomized participants exposed to investigational product (habitual, MyDay, and 1DAVTE) from time of product dispense (safety analysis set), based on treatment-specific exposure. One subject in the MyDay/1DAVTE arm wore habitual lenses during Period 1 and was not exposed to MyDay (discontinued at Period 1). An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the medical device. Ocular AEs are presented on the subject level, but reported by eye.	0.00% 0/32 • Adverse events (AEs) were collected from time of informed consent throughout the duration of a subject's participation in the study (up to 30 days). This analysis population includes all randomized participants exposed to investigational product (habitual, MyDay, and 1DAVTE) from time of product dispense (safety analysis set), based on treatment-specific exposure. One subject in the MyDay/1DAVTE arm wore habitual lenses during Period 1 and was not exposed to MyDay (discontinued at Period 1). An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the medical device. Ocular AEs are presented on the subject level, but reported by eye.	0.00% 0/60 • Adverse events (AEs) were collected from time of informed consent throughout the duration of a subject's participation in the study (up to 30 days). This analysis population includes all randomized participants exposed to investigational product (habitual, MyDay, and 1DAVTE) from time of product dispense (safety analysis set), based on treatment-specific exposure. One subject in the MyDay/1DAVTE arm wore habitual lenses during Period 1 and was not exposed to MyDay (discontinued at Period 1). An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the medical device. Ocular AEs are presented on the subject level, but reported by eye.	1.6% 1/61 • Adverse events (AEs) were collected from time of informed consent throughout the duration of a subject's participation in the study (up to 30 days). This analysis population includes all randomized participants exposed to investigational product (habitual, MyDay, and 1DAVTE) from time of product dispense (safety analysis set), based on treatment-specific exposure. One subject in the MyDay/1DAVTE arm wore habitual lenses during Period 1 and was not exposed to MyDay (discontinued at Period 1). An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the medical device. Ocular AEs are presented on the subject level, but reported by eye.

Other adverse events

Other adverse events
Measure	Pretreatment n=66 participants at risk All subjects who consented to participate in the study prior to the initiation of study treatment	Dailies Total 1 n=32 participants at risk Delefilcon A contact lenses per subject's habitual prescription worn for 10 days prior to Period 1	Clariti 1-Day n=32 participants at risk Somofilcon A contact lenses per subject's habitual prescription worn for 10 days prior to Period 1	MyDay n=60 participants at risk Stenfilcon A contact lenses worn for 10 days during Period 1 or 2 as randomized	1DAVTE n=61 participants at risk Narafilcon A contact lenses worn for 10 days during Period 1 or 2 as randomized
Infections and infestations Nasopharyngitis	0.00% 0/66 • Adverse events (AEs) were collected from time of informed consent throughout the duration of a subject's participation in the study (up to 30 days). This analysis population includes all randomized participants exposed to investigational product (habitual, MyDay, and 1DAVTE) from time of product dispense (safety analysis set), based on treatment-specific exposure. One subject in the MyDay/1DAVTE arm wore habitual lenses during Period 1 and was not exposed to MyDay (discontinued at Period 1). An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the medical device. Ocular AEs are presented on the subject level, but reported by eye.	6.2% 2/32 • Adverse events (AEs) were collected from time of informed consent throughout the duration of a subject's participation in the study (up to 30 days). This analysis population includes all randomized participants exposed to investigational product (habitual, MyDay, and 1DAVTE) from time of product dispense (safety analysis set), based on treatment-specific exposure. One subject in the MyDay/1DAVTE arm wore habitual lenses during Period 1 and was not exposed to MyDay (discontinued at Period 1). An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the medical device. Ocular AEs are presented on the subject level, but reported by eye.	0.00% 0/32 • Adverse events (AEs) were collected from time of informed consent throughout the duration of a subject's participation in the study (up to 30 days). This analysis population includes all randomized participants exposed to investigational product (habitual, MyDay, and 1DAVTE) from time of product dispense (safety analysis set), based on treatment-specific exposure. One subject in the MyDay/1DAVTE arm wore habitual lenses during Period 1 and was not exposed to MyDay (discontinued at Period 1). An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the medical device. Ocular AEs are presented on the subject level, but reported by eye.	0.00% 0/60 • Adverse events (AEs) were collected from time of informed consent throughout the duration of a subject's participation in the study (up to 30 days). This analysis population includes all randomized participants exposed to investigational product (habitual, MyDay, and 1DAVTE) from time of product dispense (safety analysis set), based on treatment-specific exposure. One subject in the MyDay/1DAVTE arm wore habitual lenses during Period 1 and was not exposed to MyDay (discontinued at Period 1). An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the medical device. Ocular AEs are presented on the subject level, but reported by eye.	0.00% 0/61 • Adverse events (AEs) were collected from time of informed consent throughout the duration of a subject's participation in the study (up to 30 days). This analysis population includes all randomized participants exposed to investigational product (habitual, MyDay, and 1DAVTE) from time of product dispense (safety analysis set), based on treatment-specific exposure. One subject in the MyDay/1DAVTE arm wore habitual lenses during Period 1 and was not exposed to MyDay (discontinued at Period 1). An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the medical device. Ocular AEs are presented on the subject level, but reported by eye.
Infections and infestations Hordeolum	0.00% 0/66 • Adverse events (AEs) were collected from time of informed consent throughout the duration of a subject's participation in the study (up to 30 days). This analysis population includes all randomized participants exposed to investigational product (habitual, MyDay, and 1DAVTE) from time of product dispense (safety analysis set), based on treatment-specific exposure. One subject in the MyDay/1DAVTE arm wore habitual lenses during Period 1 and was not exposed to MyDay (discontinued at Period 1). An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the medical device. Ocular AEs are presented on the subject level, but reported by eye.	6.2% 2/32 • Adverse events (AEs) were collected from time of informed consent throughout the duration of a subject's participation in the study (up to 30 days). This analysis population includes all randomized participants exposed to investigational product (habitual, MyDay, and 1DAVTE) from time of product dispense (safety analysis set), based on treatment-specific exposure. One subject in the MyDay/1DAVTE arm wore habitual lenses during Period 1 and was not exposed to MyDay (discontinued at Period 1). An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the medical device. Ocular AEs are presented on the subject level, but reported by eye.	0.00% 0/32 • Adverse events (AEs) were collected from time of informed consent throughout the duration of a subject's participation in the study (up to 30 days). This analysis population includes all randomized participants exposed to investigational product (habitual, MyDay, and 1DAVTE) from time of product dispense (safety analysis set), based on treatment-specific exposure. One subject in the MyDay/1DAVTE arm wore habitual lenses during Period 1 and was not exposed to MyDay (discontinued at Period 1). An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the medical device. Ocular AEs are presented on the subject level, but reported by eye.	0.00% 0/60 • Adverse events (AEs) were collected from time of informed consent throughout the duration of a subject's participation in the study (up to 30 days). This analysis population includes all randomized participants exposed to investigational product (habitual, MyDay, and 1DAVTE) from time of product dispense (safety analysis set), based on treatment-specific exposure. One subject in the MyDay/1DAVTE arm wore habitual lenses during Period 1 and was not exposed to MyDay (discontinued at Period 1). An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the medical device. Ocular AEs are presented on the subject level, but reported by eye.	0.00% 0/61 • Adverse events (AEs) were collected from time of informed consent throughout the duration of a subject's participation in the study (up to 30 days). This analysis population includes all randomized participants exposed to investigational product (habitual, MyDay, and 1DAVTE) from time of product dispense (safety analysis set), based on treatment-specific exposure. One subject in the MyDay/1DAVTE arm wore habitual lenses during Period 1 and was not exposed to MyDay (discontinued at Period 1). An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the medical device. Ocular AEs are presented on the subject level, but reported by eye.
Injury, poisoning and procedural complications Foreign body in eye	0.00% 0/66 • Adverse events (AEs) were collected from time of informed consent throughout the duration of a subject's participation in the study (up to 30 days). This analysis population includes all randomized participants exposed to investigational product (habitual, MyDay, and 1DAVTE) from time of product dispense (safety analysis set), based on treatment-specific exposure. One subject in the MyDay/1DAVTE arm wore habitual lenses during Period 1 and was not exposed to MyDay (discontinued at Period 1). An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the medical device. Ocular AEs are presented on the subject level, but reported by eye.	6.2% 2/32 • Adverse events (AEs) were collected from time of informed consent throughout the duration of a subject's participation in the study (up to 30 days). This analysis population includes all randomized participants exposed to investigational product (habitual, MyDay, and 1DAVTE) from time of product dispense (safety analysis set), based on treatment-specific exposure. One subject in the MyDay/1DAVTE arm wore habitual lenses during Period 1 and was not exposed to MyDay (discontinued at Period 1). An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the medical device. Ocular AEs are presented on the subject level, but reported by eye.	0.00% 0/32 • Adverse events (AEs) were collected from time of informed consent throughout the duration of a subject's participation in the study (up to 30 days). This analysis population includes all randomized participants exposed to investigational product (habitual, MyDay, and 1DAVTE) from time of product dispense (safety analysis set), based on treatment-specific exposure. One subject in the MyDay/1DAVTE arm wore habitual lenses during Period 1 and was not exposed to MyDay (discontinued at Period 1). An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the medical device. Ocular AEs are presented on the subject level, but reported by eye.	0.00% 0/60 • Adverse events (AEs) were collected from time of informed consent throughout the duration of a subject's participation in the study (up to 30 days). This analysis population includes all randomized participants exposed to investigational product (habitual, MyDay, and 1DAVTE) from time of product dispense (safety analysis set), based on treatment-specific exposure. One subject in the MyDay/1DAVTE arm wore habitual lenses during Period 1 and was not exposed to MyDay (discontinued at Period 1). An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the medical device. Ocular AEs are presented on the subject level, but reported by eye.	0.00% 0/61 • Adverse events (AEs) were collected from time of informed consent throughout the duration of a subject's participation in the study (up to 30 days). This analysis population includes all randomized participants exposed to investigational product (habitual, MyDay, and 1DAVTE) from time of product dispense (safety analysis set), based on treatment-specific exposure. One subject in the MyDay/1DAVTE arm wore habitual lenses during Period 1 and was not exposed to MyDay (discontinued at Period 1). An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the medical device. Ocular AEs are presented on the subject level, but reported by eye.

Additional Information

GMA Franchise Head - Vision Care, GCRA

Alcon, A Novartis Division

Phone: 1-888-451-3937

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Sponsor reserves the right of prior review of any publication or presentation of information related to the study.
Publication restrictions are in place

Restriction type: OTHER