Performance of Dailies Total1® Contact Lenses for Astigmatism in Symptomatic Habitual Reusable Toric Lens Wearers

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05498649

Enrollment

Registered

2022-08-12

Start date

2022-08-02

Completion date

2022-12-16

Last updated

2024-09-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Astigmatism

Brief summary

To subjectively evaluate Dailies Total1® contact lenses for astigmatism (DT1fA) performance compared to other common weekly/monthly contact lenses in symptomatic patients.

Detailed description

This study is a single site, prospective, subject-masked, observational study of the subjective performance of DT1fA in symptomatic patients. Subjects will be assessed at a screening visit, and 2 follow-up visits. Clinical evaluations will include measurement of visual acuity, manifest refraction, and patient questionnaires.

Interventions

DEVICEDT1fA

DT1fA contact lenses

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 38 Years

Inclusion criteria

Subjects are eligible for the study if they meet the following criteria: Note: Ocular criteria must be met in both eyes. Inclusion Criteria: * Willing and able to provide informed consent * Adult (18-38 years of age) * Adapted and optimized current reusable soft toric lens wearer who has at least 3 months of wearing experience, and typically wears lenses every day, or at least 5 days per week, ≥10 hours per day * Prescription needs with sphere and cylinder values that can be appropriately fit with current available parameters in the Dailies Total1® Contact lenses for Astigmatism product line * Vision correctable to 20/25 Snellen (0.1 logMAR) or better in each eye at 6m * Willing to wear lenses every day or at least 5 days per week, 10 or more hours per day and attend all study visits and follow instructions * CLDEQ-8 minimum score of 12

Exclusion criteria

If any of the following

Design outcomes

Primary

Measure	Time frame	Description
Contact Lens Dry Eye Questionnaire (CLDEQ-8) Score	Two to four weeks after fit with optimized prescription (Habitual lens) or two weeks after refit (Delefilcon A)	A series of 8 questions that ask participants to rate eye discomfort, eye dryness, and blurry vision on a frequency scale (0 Never, 1 Rarely, 2 Sometimes, 3 Frequently, 4 Constantly) and an intensity scale (0 Never, 1 not intense to 5 Very Intense). Scores on individual questions are added together to determine a total score. Higher values indicate worse outcomes. The minimum score is 1 and the maximum score is 37.

Other

Measure	Time frame	Description
The Percentage of Participants That Reported Little to no Intensity of Eye Dryness at Baseline and 2 Weeks of DT1fA Wear for End of Day (EOD)	Two to four weeks after fit with optimized prescription (Habitual lens) or two weeks after refit (Delefilcon A)	Participants were asked to rate end of day dryness intensity (0 Never, 1 not intense to 5 Very Intense). Higher values indicate worse outcomes.
The Percentage of Participants That Reported Little to no Noticeable Change Between Clear to Blurry or Foggy Vision at Baseline and 2 Weeks of DT1fA Wear for End of Day (EOD)	Two to four weeks after fit with optimized prescription (Habitual lens) or two weeks after refit (Delefilcon A)	Participants were asked to rate noticeable change between clear to blurry or foggy vision (0 Never, 1 not intense to 5 Very Intense). Higher values indicate worse outcomes.
The Percentage of Participants That Reported Little to no Intensity of Eye Discomfort at Baseline and 2 Weeks of DT1fA Wear for End of Day (EOD)	Two to four weeks after fit with optimized prescription (Habitual lens) or two weeks after refit (Delefilcon A)	Participants were asked to rate end of day discomfort intensity (0 Never, 1 not intense to 5 Very Intense). Higher values indicate worse outcomes.
Vision Stability	Two to four weeks after fit with optimized prescription (Habitual lens) or two weeks after refit (Delefilcon A)	—
Binocular Contact Lens Corrected Visual Acuity at Distance (6m)	Two to four weeks after fit with optimized prescription (Habitual lens) or two weeks after refit (Delefilcon A)	—
Hours of Comfortable Wear	Two to four weeks after fit with optimized prescription (Habitual lens) or two weeks after refit (Delefilcon A)	—

Countries

United States

Participant flow

Participants by arm

Arm	Count
Bilateral Use of DT1fA Contact Lenses DT1fA contact lenses DT1fA: DT1fA contact lenses	85
Total	85

Withdrawals & dropouts

Period	Reason	FG000
Overall Study	Lost to Follow-up	1

Baseline characteristics

Characteristic	Bilateral Use of DT1fA Contact Lenses	—
Age, Continuous	28.5 years STANDARD_DEVIATION 5.9	—
Race and Ethnicity Not Collected	—	— Participants
Region of Enrollment United States	85 participants	—
Sex: Female, Male Female	58 Participants	—
Sex: Female, Male Male	27 Participants	—

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	0 / 85
other Total, other adverse events	0 / 85
serious Total, serious adverse events	0 / 85

Outcome results

Primary

Contact Lens Dry Eye Questionnaire (CLDEQ-8) Score

A series of 8 questions that ask participants to rate eye discomfort, eye dryness, and blurry vision on a frequency scale (0 Never, 1 Rarely, 2 Sometimes, 3 Frequently, 4 Constantly) and an intensity scale (0 Never, 1 not intense to 5 Very Intense). Scores on individual questions are added together to determine a total score. Higher values indicate worse outcomes. The minimum score is 1 and the maximum score is 37.