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Trial Outcomes & Findings for Initial Performance of a Modified Daily Disposable Contact Lens (NCT NCT02694835)

NCT ID: NCT02694835

Last Updated: 2019-03-13

Results Overview

An AE was defined as any untoward medical occurrence in a subject who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. Reported in units of eyes.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

81 participants

Primary outcome timeframe

Day 1 at Hour 9 ± 3 hours

Results posted on

2019-03-13

Participant Flow

Subjects were recruited from 5 investigational sites located in the United States.

Of the 81 enrolled, 1 subject exited as a screen failure prior to randomization. This reporting group includes all randomized subjects (80).

Participant milestones

Participant milestones
Measure
DT1 UV
Delefilcon A contact lenses with Ultraviolet (UV) Absorber worn bilaterally (in both eyes) for 9 hours
Dailies Total1 (DT1)
Delefilcon A contact lenses worn bilaterally for 9 hours
Overall Study
STARTED
41
39
Overall Study
COMPLETED
41
39
Overall Study
NOT COMPLETED
0
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Initial Performance of a Modified Daily Disposable Contact Lens

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
DT1 UV
n=41 Participants
Delefilcon A contact lenses with Ultraviolet (UV) Absorber worn bilaterally (in both eyes) for 9 hours
Dailies Total1 (DT1)
n=39 Participants
Delefilcon A contact lenses worn bilaterally for 9 hours
Total
n=80 Participants
Total of all reporting groups
Age, Continuous
36.2 years
STANDARD_DEVIATION 8.5 • n=99 Participants
35.3 years
STANDARD_DEVIATION 9.9 • n=107 Participants
35.8 years
STANDARD_DEVIATION 9.2 • n=206 Participants
Sex: Female, Male
Female
34 Participants
n=99 Participants
23 Participants
n=107 Participants
57 Participants
n=206 Participants
Sex: Female, Male
Male
7 Participants
n=99 Participants
16 Participants
n=107 Participants
23 Participants
n=206 Participants
Race/Ethnicity, Customized
White
36 Participants
n=99 Participants
35 Participants
n=107 Participants
71 Participants
n=206 Participants
Race/Ethnicity, Customized
Black or African American
2 Participants
n=99 Participants
0 Participants
n=107 Participants
2 Participants
n=206 Participants
Race/Ethnicity, Customized
American Indian or Alaska Native
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
Race/Ethnicity, Customized
Asian
3 Participants
n=99 Participants
2 Participants
n=107 Participants
5 Participants
n=206 Participants
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Island
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
Race/Ethnicity, Customized
Multi-Racial
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
Race/Ethnicity, Customized
Other
0 Participants
n=99 Participants
2 Participants
n=107 Participants
2 Participants
n=206 Participants

PRIMARY outcome

Timeframe: Day 1 at Hour 9 ± 3 hours

Population: Full Analysis Set

An AE was defined as any untoward medical occurrence in a subject who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. Reported in units of eyes.

Outcome measures

Outcome measures
Measure
DT1 UV
n=41 Participants
Delefilcon A contact lenses with Ultraviolet (UV) Absorber worn bilaterally (in both eyes) for 9 hours
Dailies Total1 (DT1)
n=78 Eyes
Delefilcon A contact lenses worn bilaterally for 9 hours
Incidence (Number) of Ocular Discomfort Device-related Adverse Events (AEs)
0 Eyes
0 Eyes

Adverse Events

DT1 UV

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

Dailies Total1 (DT1)

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

Clinical Project Lead, Vision Care

Alcon, A Novartis Division

Phone: 1-888-451-3937

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