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Trial Outcomes & Findings for Clinical Comparison of Two Daily Disposable Soft Contact Lenses (NCT NCT03518008)

NCT ID: NCT03518008

Last Updated: 2019-04-03

Results Overview

Overall quality of vision was measured as a subjective rating, collected binocularly on a scale of 1 (Poor) to 10 (Excellent). No inferences were made; therefore, no hypotheses were formulated.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

22 participants

Primary outcome timeframe

Day 8, each product

Results posted on

2019-04-03

Participant Flow

Subjects were recruited from 1 investigative site located in the United States.

A total of 22 subjects signed informed consent to participate in the study. This reporting group includes all randomized and exposed subjects (22).

Participant milestones

Participant milestones
Measure
DDT2, Then Clariti 1 Day
Verofilcon A contact lenses worn first, with somofilcon A contact lenses worn second. Each product will be worn bilaterally (in both eyes) for 1 week in a daily disposable modality.
Clariti 1 Day, Then DDT2
Somofilcon A contact lenses worn first, with verofilcon A contact lenses worn second. Each product will be worn bilaterally for 1 week in a daily disposable modality.
Period 1, First Week of Wear
STARTED
11
11
Period 1, First Week of Wear
COMPLETED
11
11
Period 1, First Week of Wear
NOT COMPLETED
0
0
Period 2, Second Week of Wear
STARTED
11
11
Period 2, Second Week of Wear
COMPLETED
11
10
Period 2, Second Week of Wear
NOT COMPLETED
0
1

Reasons for withdrawal

Reasons for withdrawal
Measure
DDT2, Then Clariti 1 Day
Verofilcon A contact lenses worn first, with somofilcon A contact lenses worn second. Each product will be worn bilaterally (in both eyes) for 1 week in a daily disposable modality.
Clariti 1 Day, Then DDT2
Somofilcon A contact lenses worn first, with verofilcon A contact lenses worn second. Each product will be worn bilaterally for 1 week in a daily disposable modality.
Period 2, Second Week of Wear
Family emergency
0
1

Baseline Characteristics

Clinical Comparison of Two Daily Disposable Soft Contact Lenses

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Overall
n=22 Participants
Verofilcon A and somofilcon A contact lenses worn during Period 1 and Period 2 in a crossover assignment, as randomized.
Age, Continuous
32.1 years
STANDARD_DEVIATION 6.4 • n=5 Participants
Sex: Female, Male
Female
14 Participants
n=5 Participants
Sex: Female, Male
Male
8 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
3 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
19 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
n=5 Participants
Race/Ethnicity, Customized
White
22 Participants
n=5 Participants
Race/Ethnicity, Customized
Black or African American
0 Participants
n=5 Participants
Race/Ethnicity, Customized
American Indian or Alaska Native
0 Participants
n=5 Participants
Race/Ethnicity, Customized
Asian
0 Participants
n=5 Participants
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
0 Participants
n=5 Participants
Race/Ethnicity, Customized
Other
0 Participants
n=5 Participants

PRIMARY outcome

Timeframe: Day 8, each product

Population: Safety Analysis Set

Overall quality of vision was measured as a subjective rating, collected binocularly on a scale of 1 (Poor) to 10 (Excellent). No inferences were made; therefore, no hypotheses were formulated.

Outcome measures

Outcome measures
Measure
DD T2
n=22 Participants
Verofilcon A contact lenses worn bilaterally (in both eyes) during Period 1 or Period 2 for 1 week in a daily disposable modality
Clariti 1 Day
n=22 Participants
Somofilcon A contact lenses worn bilaterally during Period 1 or Period 2 for 1 week in a daily disposable modality.
Overall Quality of Vision
9.2 units on a scale
Standard Deviation 1.0
8.6 units on a scale
Standard Deviation 1.5

Adverse Events

DD T2

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

Clariti 1 Day

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

Senior Clinical Project Lead, GCRA - Vision Care

Alcon Research

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