Trial Outcomes & Findings for Comparison of Two Daily Disposable Contact Lenses Over 1-week of Wear (NCT NCT01669629)

Results Overview

Measured on a 5 point-scale of excellence (excellent, very good, good, fair and poor) per a participant. Outcome is reported as aggregate number of subjects who reported Excellent/Very Good at their 1-week visit.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

183 participants

Primary outcome timeframe

6-10 Days

Results posted on

2018-06-19

Participant Flow

There were 183 subjects enrolled with 183 subjects randomized.

Participant milestones

Participant milestones
Measure	Delefilcon A \ Etafilcon A 6-10 days of delefilcon A soft contact lens wear first then 6-10 days of etafilcon A soft contact lens wear delefilcon A: Daily wear soft contact lens for bilateral distance vision correction use. etafilcon A: Daily wear soft contact lens for bilateral distance vision correction use.	Etafilcon A \ Delefilcon A 6-10 days of etafilcon A soft contact lens wear first then 6-10 days of delefilcon A soft contact lens wear delefilcon A: Daily wear soft contact lens for bilateral distance vision correction use. etafilcon A: Daily wear soft contact lens for bilateral distance vision correction use.
Period 1 STARTED	92	91
Period 1 COMPLETED	91	89
Period 1 NOT COMPLETED	1	2
Period 2 STARTED	91	89
Period 2 COMPLETED	91	89
Period 2 NOT COMPLETED	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Delefilcon A \ Etafilcon A 6-10 days of delefilcon A soft contact lens wear first then 6-10 days of etafilcon A soft contact lens wear delefilcon A: Daily wear soft contact lens for bilateral distance vision correction use. etafilcon A: Daily wear soft contact lens for bilateral distance vision correction use.	Etafilcon A \ Delefilcon A 6-10 days of etafilcon A soft contact lens wear first then 6-10 days of delefilcon A soft contact lens wear delefilcon A: Daily wear soft contact lens for bilateral distance vision correction use. etafilcon A: Daily wear soft contact lens for bilateral distance vision correction use.
Period 1 protocol deviation	1	2

Baseline Characteristics

Comparison of Two Daily Disposable Contact Lenses Over 1-week of Wear

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Subjects n=183 Participants All subjects who were enrolled in the study.
Age, Continuous	31.61 years STANDARD_DEVIATION 7.061 • n=5 Participants
Sex: Female, Male Female	125 Participants n=5 Participants
Sex: Female, Male Male	58 Participants n=5 Participants
Region of Enrollment United States	183 participants n=5 Participants

PRIMARY outcome

Timeframe: 6-10 Days

Population: Subjects analyzed were those who enrolled, randomized, and completed the study per protocol.

Measured on a 5 point-scale of excellence (excellent, very good, good, fair and poor) per a participant. Outcome is reported as aggregate number of subjects who reported Excellent/Very Good at their 1-week visit.

Outcome measures

Outcome measures
Measure	Delefilcon A n=180 Participants Subjects that received the delefilcon A lens in either the first or second period of the study.	Etafilcon A n=180 Participants Subjects that received the etafilcon A lens in either the first or second period of the study.
Subject Reported Ease of Removal	47.2 percentage of participants	75.6 percentage of participants

SECONDARY outcome

Timeframe: 6-10 Days

Measured on a 5 point-scale of excellence (excellent, very good, good, fair and poor) per a participant. Summary is reported as an aggregate of Excellent/Very Good at their 1-week visit.

Outcome measures

Outcome measures
Measure	Delefilcon A n=180 Participants Subjects that received the delefilcon A lens in either the first or second period of the study.	Etafilcon A n=180 Participants Subjects that received the etafilcon A lens in either the first or second period of the study.
Subject Reported Overall Comfort	71.1 percentage of participants	61.1 percentage of participants

SECONDARY outcome

Timeframe: 6-10 Days

Measured on a 5 point-scale of excellence (excellent, very good, good, fair and poor) per a participant using an aggregate summary of excellent/very good at their 1-week visit.

Outcome measures

Outcome measures
Measure	Delefilcon A n=180 Participants Subjects that received the delefilcon A lens in either the first or second period of the study.	Etafilcon A n=180 Participants Subjects that received the etafilcon A lens in either the first or second period of the study.
Subject Reported Overall Vision	76.1 percentage of participants	72.2 percentage of participants

SECONDARY outcome

Timeframe: 6-10 Days

Population: Subjects are those who were enrolled, randomized, and completed the study per protocol. Number of subjects is total in sample due to stratification by device and binocular measurement setting only.

Snellen visual acuity percentage of eyes with a visual acuity of eyesight testing at a 20/20 level or better by eye.

Outcome measures

Outcome measures
Measure	Delefilcon A n=360 Eyes Subjects that received the delefilcon A lens in either the first or second period of the study.	Etafilcon A n=360 Eyes Subjects that received the etafilcon A lens in either the first or second period of the study.
Binocular Snellen Visual Acuity	95.0 percentage of eyes	94.7 percentage of eyes

SECONDARY outcome

Timeframe: 6-10 Days

Population: Subjects are those who were enrolled, randomized, and completed the study per protocol. Percentage of eyes.

Proportion of subjects that have corneal staining on the 0-4 the NEI/Industry Workshop guidelines scale, measured by eye. Grade 1 or higher is reported as a percentage of total eyes.

Outcome measures

Outcome measures
Measure	Delefilcon A n=360 eyes Subjects that received the delefilcon A lens in either the first or second period of the study.	Etafilcon A n=360 eyes Subjects that received the etafilcon A lens in either the first or second period of the study.
Overall Corneal Staining	19.4 percentage of eyes	11.9 percentage of eyes

Adverse Events

Delefilcon A

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Etafilcon A

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Kathy Osborn, OD, MS, FAAO, FBCLA Senior Principal Research Optometrist

Vistakon

Phone: 904 443-1032

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60