Trial Outcomes & Findings for Success of Dailies Total1 for Astigmatism Contact Lenses in Patients That Have Previously Failed With Toric Contact Lenses (NCT NCT05886452)

Results Overview

A questionnaire will be administered. Subjects are asked to rate their satisfaction with comfort and vision on a scale of 0 to 100, with higher ratings indicating higher satisfaction with comfort and vision.

Recruitment status

COMPLETED

Target enrollment

65 participants

Primary outcome timeframe

After 30 days of DT1fA contact lens wear

Results posted on

2025-03-25

Participant Flow

Participant milestones

Participant milestones
Measure	DT1fA Contact Lenses Subjects fitted with DT1fA contact lenses DT1fA contact lenses: Subjects will be fitted with DT1fA contact lenses
Overall Study STARTED	65
Overall Study COMPLETED	65
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	DT1fA Contact Lenses n=65 Participants Subjects fitted with DT1fA contact lenses DT1fA contact lenses: Subjects will be fitted with DT1fA contact lenses
Age, Continuous	29.5 years STANDARD_DEVIATION 5 • n=65 Participants
Sex: Female, Male Female	50 Participants n=65 Participants
Sex: Female, Male Male	15 Participants n=65 Participants

PRIMARY outcome

Timeframe: After 30 days of DT1fA contact lens wear

A questionnaire will be administered. Subjects are asked to rate their satisfaction with comfort and vision on a scale of 0 to 100, with higher ratings indicating higher satisfaction with comfort and vision.

Outcome measures

Outcome measures
Measure	DT1fA Contact Lenses n=65 Participants Subjects fitted with DT1fA contact lenses DT1fA contact lenses: Subjects will be fitted with DT1fA contact lenses
Percentage of Patients With Positive Ratings (>50 Out of 100) for Satisfaction of Comfort and Vision.	57 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: After 30 days of DT1fA contact lens wear

A questionnaire will be administered. Subjects are asked to rate their satisfaction with end of day comfort and vision on a Likert scale (Strongly Disagree, Disagree, Neither Disagree nor Agree, Agree, Strongly Agree). Satisfaction was determined as subjects answering "Agree" or "Strongly Agree".

Outcome measures

Outcome measures
Measure	DT1fA Contact Lenses n=65 Participants Subjects fitted with DT1fA contact lenses DT1fA contact lenses: Subjects will be fitted with DT1fA contact lenses
Percentage of Patients Reporting Satisfaction of Overall and End of Day (EOD) Comfort and Vision; Comfort and Vision Under Real-world Conditions Related to Computer (or Tablet) Usage and Cellphone Usage.	36 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: After 30 days of DT1fA contact lens wear

A questionnaire will be administered. Subjects are asked to rate their desire to remain in DT1fA contact lenses a Likert scale (Strongly Disagree, Disagree, Neither Disagree nor Agree, Agree, Strongly Agree). Desire to remain was determined as subjects answering "Agree" or "Strongly Agree".

Outcome measures

Outcome measures
Measure	DT1fA Contact Lenses n=65 Participants Subjects fitted with DT1fA contact lenses DT1fA contact lenses: Subjects will be fitted with DT1fA contact lenses
Percentage of Patients Reporting a Desire to Remain in DT1fA Lenses After Study is Concluded.	38 Participants

Adverse Events

DT1fA Contact Lenses

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 Phillip Brunson

Mann Eye Institute

Phone: 17135802500

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place