Trial Outcomes & Findings for Clinical Comparison of 4 Daily Disposable Soft Contact Lenses (NCT NCT03349632)

Last Updated: 2019-02-22

Results Overview

Overall quality of vision was collected binocularly and rated on a 10-point scale with 1 = poor to 10 = excellent. Subjects were asked "Thinking back over the last week, please rate our study lenses. Rate eyes together." No formal hypotheses was conducted; hence no inferential testing was performed.

Recruitment status

COMPLETED

Study phase

Target enrollment

68 participants

Primary outcome timeframe

Day 8, each product

Results posted on

2019-02-22

Participant Flow

Subjects were recruited from 3 investigational sites located in the United States.

Of the 68 enrolled, 2 subjects exited as screen failures prior to randomization. This reporting group includes all randomized subjects (66).

Participant milestones

Participant milestones
Measure	DD T2/Oasys 1-Day (Sequence 1) Verofilcon A contact lenses worn in Period 1, followed by senofilcon A contact lenses worn in Period 2. Each product worn bilaterally (in both eyes) for 1 week on a daily wear basis, as randomized	Oasys 1-Day/DD T2 (Sequence 2) Senofilcon A contact lenses worn in Period 1, followed by verofilcon A contact lenses worn in Period 2. Each product worn bilaterally for 1 week on a daily wear basis, as randomized	DD T2/MyDay (Sequence 3) Verofilcon A contact lenses worn in Period 1, followed by stenfilcon A contact lenses worn in Period 2. Each product worn bilaterally for 1 week on a daily wear basis, as randomized	MyDay/DD T2 (Sequence 4) Stenfilcon A contact lenses worn in Period 1, followed by verofilcon A contact lenses worn in Period 2. Each product worn bilaterally for 1 week on a daily wear basis, as randomized	DD T2/Moist (Sequence 5) Verofilcon A contact lenses worn in Period 1, followed by etafilcon A contact lenses worn in Period 2. Each product worn bilaterally for 1 week on a daily wear basis, as randomized	Moist/DD T2 (Sequence 6) Etafilcon A contact lenses worn in Period 1, followed by verofilcon A contact lenses worn in Period 2. Each product worn bilaterally for 1 week on a daily wear basis, as randomized
Period 1, First Week of Wear STARTED	11	11	11	11	11	11
Period 1, First Week of Wear COMPLETED	11	11	11	11	11	11
Period 1, First Week of Wear NOT COMPLETED	0	0	0	0	0	0
Period 2, Second Week of Wear STARTED	11	11	11	11	11	11
Period 2, Second Week of Wear COMPLETED	11	11	11	11	11	11
Period 2, Second Week of Wear NOT COMPLETED	0	0	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Clinical Comparison of 4 Daily Disposable Soft Contact Lenses

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Overall n=66 Participants Verofilcon A contact lenses with corresponding control product (senofilcon A, stenfilcon A, or etafilcon) worn during Period 1 and Period 2 in a crossover assignment, as randomized.
Age, Continuous	32.9 years STANDARD_DEVIATION 9.1 • n=5 Participants
Sex: Female, Male Female	46 Participants n=5 Participants
Sex: Female, Male Male	20 Participants n=5 Participants
Race/Ethnicity, Customized White	56 Participants n=5 Participants
Race/Ethnicity, Customized Black or African American	6 Participants n=5 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	0 Participants n=5 Participants
Race/Ethnicity, Customized Asian	4 Participants n=5 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Day 8, each product

Population: Safety Analysis Set