Trial Outcomes & Findings for Subjective Wearing Experience of the Total30 for Astigmatism Lens Among Satisfied Biofinity Toric Lens Wearers (NCT NCT05938010)

Results Overview

Subjects will give a rating between 0 and 10 (with 0 indicating not satisfactory at all and 10 indicating extremely satisfactory) best describing their comfort.

Recruitment status

COMPLETED

Target enrollment

42 participants

Primary outcome timeframe

After 1 month of wear

Results posted on

2024-11-14

Participant Flow

Participant milestones

Participant milestones
Measure	Dailies Total1® Contact Lenses for Astigmatism (T30fA) Dailies Total1® contact lenses for astigmatism (T30fA) Dailies Total1® contact lenses for astigmatism (T30fA): Dailies Total1® contact lenses for astigmatism (T30fA)
Overall Study STARTED	42
Overall Study COMPLETED	40
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Dailies Total1® Contact Lenses for Astigmatism (T30fA) Dailies Total1® contact lenses for astigmatism (T30fA) Dailies Total1® contact lenses for astigmatism (T30fA): Dailies Total1® contact lenses for astigmatism (T30fA)
Overall Study Lost to Follow-up	2

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Dailies Total1® Contact Lenses for Astigmatism (T30fA) n=40 Participants Dailies Total1® contact lenses for astigmatism (T30fA) Dailies Total1® contact lenses for astigmatism (T30fA): Dailies Total1® contact lenses for astigmatism (T30fA)
Age, Continuous	29.2 years STANDARD_DEVIATION 5.6 • n=40 Participants
Sex: Female, Male Female	28 Participants n=40 Participants
Sex: Female, Male Male	12 Participants n=40 Participants

PRIMARY outcome

Timeframe: After 1 month of wear

Subjects will give a rating between 0 and 10 (with 0 indicating not satisfactory at all and 10 indicating extremely satisfactory) best describing their comfort.

Outcome measures

Outcome measures
Measure	Dailies Total1® Contact Lenses for Astigmatism (T30fA) n=40 Participants Dailies Total1® contact lenses for astigmatism (T30fA) Dailies Total1® contact lenses for astigmatism (T30fA): Dailies Total1® contact lenses for astigmatism (T30fA)
Satisfaction With Comfort of T30fA Lens	8 score on a scale Interval 7.0 to 9.0

OTHER_PRE_SPECIFIED outcome

Timeframe: After 1 month of wear

Subjects will give a rating between 0 and 10 (with 0 indicating not satisfactory at all and 10 indicating extremely satisfactory) best describing their comfort.

Outcome measures

Outcome measures
Measure	Dailies Total1® Contact Lenses for Astigmatism (T30fA) n=40 Participants Dailies Total1® contact lenses for astigmatism (T30fA) Dailies Total1® contact lenses for astigmatism (T30fA): Dailies Total1® contact lenses for astigmatism (T30fA)
Satisfaction With Visual Performance of T30fA Lens	8 score on a scale Interval 8.0 to 9.3

OTHER_PRE_SPECIFIED outcome

Timeframe: After 1 month of wear

Subjects will give a rating between 0 and 10 (with 0 indicating not satisfactory at all and 10 indicating extremely satisfactory) best describing their comfort.

Outcome measures

Outcome measures
Measure	Dailies Total1® Contact Lenses for Astigmatism (T30fA) n=40 Participants Dailies Total1® contact lenses for astigmatism (T30fA) Dailies Total1® contact lenses for astigmatism (T30fA): Dailies Total1® contact lenses for astigmatism (T30fA)
Satisfaction With End of Day Comfort of T30fA Lens	7 score on a scale Interval 4.7 to 8.0

OTHER_PRE_SPECIFIED outcome

Timeframe: After 1 month of wear

Subjects will give a rating between 0 and 10 (with 0 indicating not satisfactory at all and 10 indicating extremely satisfactory) best describing their comfort.

Outcome measures

Outcome measures
Measure	Dailies Total1® Contact Lenses for Astigmatism (T30fA) n=40 Participants Dailies Total1® contact lenses for astigmatism (T30fA) Dailies Total1® contact lenses for astigmatism (T30fA): Dailies Total1® contact lenses for astigmatism (T30fA)
Satisfaction With Ease of Handling of T30fA Lens	9 score on a scale Interval 8.0 to 10.0

OTHER_PRE_SPECIFIED outcome

Timeframe: After 1 month of wear

Subjects will give a rating between 0 and 10 (with 0 indicating not satisfactory at all and 10 indicating extremely satisfactory) best describing their comfort.

Outcome measures

Outcome measures
Measure	Dailies Total1® Contact Lenses for Astigmatism (T30fA) n=40 Participants Dailies Total1® contact lenses for astigmatism (T30fA) Dailies Total1® contact lenses for astigmatism (T30fA): Dailies Total1® contact lenses for astigmatism (T30fA)
Satisfaction Overall of Handling of T30fA Lens	8 score on a scale Interval 7.0 to 9.0

Adverse Events

Dailies Total1® Contact Lenses for Astigmatism (T30fA)

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

Dr Jay Mashouf

Scripps Optometric Group

Phone: 1-858-530-2800

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place