Trial Outcomes & Findings for Clinical Evaluation of DAILIES TOTAL 1® Performance in a Japanese Population (NCT NCT02710292)

NCT ID: NCT02710292

Last Updated: 2018-07-02

Results Overview

Lens centration was assessed by the investigator on a 5-point scale, where 0=Optimal and 4=Severe decentration (with corneal exposure). Both eyes contributed to the analysis.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 104 participants
• Primary outcome timeframe: Day 10, each product
• Results posted on: 2018-07-02

Participant Flow

Subjects were recruited from 6 study sites located in Japan.

Of the 104 subjects, 5 were exited as screen failures prior to being enrolled. This reporting group includes all enrolled subjects (99).

Participant milestones

Measure	DT1, Then TE Delefilcon A contact lenses worn first, followed by narafilcon A contact lenses. Each product will be worn bilaterally (in both eyes) for at least 7 days in a daily disposable modality.	TE, Then DT1 Narafilcon A contact lenses worn first, followed by delefilcon A contact lenses. Each product will be worn bilaterally (in both eyes) for at least 7 days in a daily disposable modality.
Period 1, First 10 Days of Wear STARTED	47	52
Period 1, First 10 Days of Wear COMPLETED	46	49
Period 1, First 10 Days of Wear NOT COMPLETED	1	3
Period 2, Second 10 Days of Wear STARTED	46	49
Period 2, Second 10 Days of Wear COMPLETED	46	49
Period 2, Second 10 Days of Wear NOT COMPLETED	0	0

Reasons for withdrawal

Measure	DT1, Then TE Delefilcon A contact lenses worn first, followed by narafilcon A contact lenses. Each product will be worn bilaterally (in both eyes) for at least 7 days in a daily disposable modality.	TE, Then DT1 Narafilcon A contact lenses worn first, followed by delefilcon A contact lenses. Each product will be worn bilaterally (in both eyes) for at least 7 days in a daily disposable modality.
Period 1, First 10 Days of Wear Adverse Event	0	1
Period 1, First 10 Days of Wear Withdrawal by Subject	1	2

Baseline Characteristics

Clinical Evaluation of DAILIES TOTAL 1® Performance in a Japanese Population

Baseline characteristics by cohort

Measure	Overall n=99 Participants Delefilcon A and narafilcon A contact lenses worn during Period 1 and Period 2 in a crossover assignment.
Age, Continuous	39.9 years STANDARD_DEVIATION 9.7 • n=5 Participants
Sex: Female, Male Female	72 Participants n=5 Participants
Sex: Female, Male Male	27 Participants n=5 Participants

PRIMARY outcome

Timeframe: Day 10, each product

Population: This analysis population includes all subjects who used the study device and in whom data after the use of the study device were available (Full Analysis Set).

Lens centration was assessed by the investigator on a 5-point scale, where 0=Optimal and 4=Severe decentration (with corneal exposure). Both eyes contributed to the analysis.

Outcome measures

Measure	Dailies Total1 n=95 Participants Delefilcon A contact lenses worn bilaterally during Period 1 or Period 2 for for at least 7 days in a daily disposable modality.	TruEye n=97 Participants Narafilcon A contact lenses worn bilaterally during Period 1 or Period 2 for at least 7 days in a daily disposable modality.
Percentage of Subjects With Investigator-rated Lens Centration of "Optimal" After 10 Days of Wear	89.5 percentage of subjects	47.4 percentage of subjects

Adverse Events

Pretreatment

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Dailies Total1

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

TruEye

Serious events: 0 serious events

Other events: 23 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Pretreatment n=104 participants at risk All subjects who consented to participate in the study prior to initiation of study treatment	Dailies Total1 n=96 participants at risk All subjects exposed to delefilcon A contact lenses	TruEye n=98 participants at risk All subjects exposed to narafilcon A contact lenses
Eye disorders Dry Eye	0.00% 0/104 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 26 days). AEs are reported as pretreatment and treatment-emergent. AEs were 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 investigational medical device (test article). AE's were obtained as volunteered and elicited comments from the subjects and as observations by the Investigator.	5.2% 5/96 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 26 days). AEs are reported as pretreatment and treatment-emergent. AEs were 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 investigational medical device (test article). AE's were obtained as volunteered and elicited comments from the subjects and as observations by the Investigator.	5.1% 5/98 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 26 days). AEs are reported as pretreatment and treatment-emergent. AEs were 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 investigational medical device (test article). AE's were obtained as volunteered and elicited comments from the subjects and as observations by the Investigator.
Eye disorders Punctate keratitis	0.00% 0/104 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 26 days). AEs are reported as pretreatment and treatment-emergent. AEs were 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 investigational medical device (test article). AE's were obtained as volunteered and elicited comments from the subjects and as observations by the Investigator.	2.1% 2/96 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 26 days). AEs are reported as pretreatment and treatment-emergent. AEs were 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 investigational medical device (test article). AE's were obtained as volunteered and elicited comments from the subjects and as observations by the Investigator.	19.4% 19/98 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 26 days). AEs are reported as pretreatment and treatment-emergent. AEs were 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 investigational medical device (test article). AE's were obtained as volunteered and elicited comments from the subjects and as observations by the Investigator.

Additional Information

Clinical Manager

Alcon Japan Ltd.

Phone: 1-888-451-3937

Email: alcon.medinfo@alcon.com

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