Trial Outcomes & Findings for Dailies Total 1 Sphere Contact Lenses (NCT NCT05239494)

Last Updated: 2024-10-01

Results Overview

The median visual analog scale (VAS) scores at the 1-month visit (-50 to +50 scale with scores greater than 0 being comfortable).

Recruitment status

COMPLETED

Study phase

Target enrollment

60 participants

Primary outcome timeframe

1 month

Results posted on

2024-10-01

Participant Flow

Participant milestones

Participant milestones
Measure	Dailies Total1 All participants will be asked to wear Dailies Total1 for the duration of this study. DT1 Sphere Contact Lenses: Devices: Dailies Total 1 Sphere Contact Lenses
Overall Study STARTED	60
Overall Study COMPLETED	59
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Dailies Total1 All participants will be asked to wear Dailies Total1 for the duration of this study. DT1 Sphere Contact Lenses: Devices: Dailies Total 1 Sphere Contact Lenses
Overall Study Lost to Follow-up	1

Baseline Characteristics

Dailies Total 1 Sphere Contact Lenses

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Dailies Total1 n=60 Participants All participants will be asked to wear Dailies Total1 for the duration of this study. DT1 Sphere Contact Lenses: Devices: Dailies Total 1 Sphere Contact Lenses
Age, Categorical <=18 years	0 Participants n=99 Participants
Age, Categorical Between 18 and 65 years	60 Participants n=99 Participants
Age, Categorical >=65 years	0 Participants n=99 Participants
Age, Continuous	24 years n=99 Participants
Sex: Female, Male Female	42 Participants n=99 Participants
Sex: Female, Male Male	18 Participants n=99 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=99 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	59 Participants n=99 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=99 Participants
Race (NIH/OMB) Asian	6 Participants n=99 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants
Race (NIH/OMB) Black or African American	2 Participants n=99 Participants
Race (NIH/OMB) White	51 Participants n=99 Participants
Race (NIH/OMB) More than one race	0 Participants n=99 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=99 Participants
Region of Enrollment United States	60 participants n=99 Participants

PRIMARY outcome

Timeframe: 1 month

Population: Subjects were recruited via clinic records, email and fliers, and they were pre-screened with an Institutional Review Board (IRB)- approved qualification questionnaire over the telephone. Adult, 18- to 40-year-old (inclusive), past CL wearers who had a Logarithm of the Minimum Angle of Resolution (logMAR) best-corrected visual acuity of 0.00 or better were recruited. Subjects were required to have worn CLs for at least 1year in the past.

The median visual analog scale (VAS) scores at the 1-month visit (-50 to +50 scale with scores greater than 0 being comfortable).

Outcome measures

Outcome measures
Measure	Dailies Total1 n=60 Participants All participants will be asked to wear Dailies Total1 for the duration of this study. DT1 Sphere Contact Lenses: Devices: Dailies Total 1 Sphere Contact Lenses
Visual Analog Scale (VAS) Contact Lenses Comfort Scores	44 Score on a scale Interval 40.0 to 48.0

SECONDARY outcome

Timeframe: One Month

Population: All subjects who completed the 1 month visit.

Number of participants who were likely to refer the study contact lens to a friend.

Outcome measures

Outcome measures
Measure	Dailies Total1 n=60 Participants All participants will be asked to wear Dailies Total1 for the duration of this study. DT1 Sphere Contact Lenses: Devices: Dailies Total 1 Sphere Contact Lenses
Likert Questionnaire	59 Participants

Adverse Events

Dailies Total1

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

Andrew Pucker, OD, PhD

University of Alabama at Birmingham

Phone: 920-579-2900

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place