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Trial Outcomes & Findings for Clinical Assessment of a Daily Disposable Soft Silicone Hydrogel Contact Lens (NCT NCT06044948)

NCT ID: NCT06044948

Last Updated: 2024-11-20

Results Overview

Visual acuity (VA) was measured for each eye individually with study lenses on eye using letter charts. VA was recorded in Snellen where 20/20 represents normal distance eyesight and 20/15 represents better than normal eyesight. No hypothesis testing was prespecified for this endpoint.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

97 participants

Primary outcome timeframe

Week 1

Results posted on

2024-11-20

Participant Flow

Participants were recruited from 6 investigative sites located in 1 country (US).

Of the 97 enrolled, 1 subject was exited as a screen failure prior to being exposed to the product. This reporting group includes all participants who were exposed to the product (96).

Unit of analysis: eyes

Participant milestones

Participant milestones
Measure
DAILIES TOTAL1
Delefilcon A contact lenses (daily disposable, silicone hydrogel spherical contact lenses) worn in both eyes for the typical number of hours the subject wears his/her habitual contact lenses. The lenses were worn in a daily disposable manner.
Overall Study
STARTED
96 192
Overall Study
COMPLETED
96 192
Overall Study
NOT COMPLETED
0 0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Clinical Assessment of a Daily Disposable Soft Silicone Hydrogel Contact Lens

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
DAILIES TOTAL1
n=96 Participants
Delefilcon A contact lenses (daily disposable, silicone hydrogel spherical contact lenses) worn in both eyes for the typical number of hours the subject wears his/her habitual contact lenses. The lenses were worn in a daily disposable manner.
Age, Continuous
35.9 years
STANDARD_DEVIATION 8.7 • n=5 Participants
Sex: Female, Male
Female
65 Participants
n=5 Participants
Sex: Female, Male
Male
31 Participants
n=5 Participants
Race/Ethnicity, Customized
White
83 Participants
n=5 Participants
Race/Ethnicity, Customized
Black or African American
9 Participants
n=5 Participants
Race/Ethnicity, Customized
American Indian or Alaska Native
0 Participants
n=5 Participants
Race/Ethnicity, Customized
Asian
1 Participants
n=5 Participants
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
0 Participants
n=5 Participants
Race/Ethnicity, Customized
Other
2 Participants
n=5 Participants
Race/Ethnicity, Customized
Multi-racial
1 Participants
n=5 Participants
Race/Ethnicity, Customized
Hispanic or Latino
3 Participants
n=5 Participants
Race/Ethnicity, Customized
Not Hispanic or Latino
93 Participants
n=5 Participants

PRIMARY outcome

Timeframe: Week 1

Population: The safety analysis set included all subjects/eyes exposed to DAILIES TOTAL1 lenses evaluated in this study.

Visual acuity (VA) was measured for each eye individually with study lenses on eye using letter charts. VA was recorded in Snellen where 20/20 represents normal distance eyesight and 20/15 represents better than normal eyesight. No hypothesis testing was prespecified for this endpoint.

Outcome measures

Outcome measures
Measure
DAILIES TOTAL1
n=96 Participants
Delefilcon A contact lenses (daily disposable, silicone hydrogel spherical contact lenses) worn in both eyes for the typical number of hours the subject wears his/her habitual contact lenses. The lenses were worn in a daily disposable manner.
Distance VA With Study Lenses at Week 1
20/15
95 eyes
Distance VA With Study Lenses at Week 1
20/20
92 eyes
Distance VA With Study Lenses at Week 1
20/25
5 eyes

Adverse Events

Pretreatment

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

DAILIES TOTAL1 Ocular

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

DAILIES TOTAL1 Nonocular

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

Sr. Clinical Project Lead, Vision Care

Alcon Research, LLC

Phone: 8884513937

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