Trial Outcomes & Findings for Performance of Dailies Total1® Contact Lenses for Astigmatism in Symptomatic Habitual Reusable Toric Lens Wearers (NCT NCT05498649)

NCT ID: NCT05498649

Last Updated: 2024-09-19

Results Overview

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.

Recruitment status

COMPLETED

Target enrollment

86 participants

Primary outcome timeframe

Two to four weeks after fit with optimized prescription (Habitual lens) or two weeks after refit (Delefilcon A)

Results posted on

2024-09-19

Participant Flow

Participant milestones

Participant milestones
Measure	Bilateral Use of DT1fA Contact Lenses DT1fA contact lenses DT1fA: DT1fA contact lenses
Overall Study STARTED	86
Overall Study COMPLETED	85
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Bilateral Use of DT1fA Contact Lenses DT1fA contact lenses DT1fA: DT1fA contact lenses
Overall Study Lost to Follow-up	1

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Bilateral Use of DT1fA Contact Lenses n=85 Participants DT1fA contact lenses DT1fA: DT1fA contact lenses
Age, Continuous	28.5 years STANDARD_DEVIATION 5.9 • n=85 Participants
Sex: Female, Male Female	58 Participants n=85 Participants
Sex: Female, Male Male	27 Participants n=85 Participants
Region of Enrollment United States	85 participants n=85 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Habitual Lens n=85 Participants New habitual toric lenses with an optimized prescription	Delefilcon A n=85 Participants Refit with delefilcon A for astigmatism
Contact Lens Dry Eye Questionnaire (CLDEQ-8) Score	16.8 score on a scale Standard Deviation 8.1	12.4 score on a scale Standard Deviation 7.5

OTHER_PRE_SPECIFIED outcome

Timeframe: Two to four weeks after fit with optimized prescription (Habitual lens) or two weeks after refit (Delefilcon A)

Population: Percentage that reported little to no intensity of eye discomfort (responding 0, 1, or 2).

Participants were asked to rate end of day discomfort intensity (0 Never, 1 not intense to 5 Very Intense). Higher values indicate worse outcomes.

Outcome measures

Outcome measures
Measure	Habitual Lens n=85 Participants New habitual toric lenses with an optimized prescription	Delefilcon A n=85 Participants Refit with delefilcon A for astigmatism
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)	67 Participants	44 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Two to four weeks after fit with optimized prescription (Habitual lens) or two weeks after refit (Delefilcon A)

Population: Percentage that reported little to no intensity of dryness (responding 0, 1, or 2).

Participants were asked to rate end of day dryness intensity (0 Never, 1 not intense to 5 Very Intense). Higher values indicate worse outcomes.

Outcome measures

Outcome measures
Measure	Habitual Lens n=85 Participants New habitual toric lenses with an optimized prescription	Delefilcon A n=85 Participants Refit with delefilcon A for astigmatism
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)	66 Participants	43 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Two to four weeks after fit with optimized prescription (Habitual lens) or two weeks after refit (Delefilcon A)

Population: Percentage that reported little to no noticeable change between clear to blurry or foggy vision (responding 0, 1, or 2).

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.

Outcome measures

Outcome measures
Measure	Habitual Lens n=85 Participants New habitual toric lenses with an optimized prescription	Delefilcon A n=85 Participants Refit with delefilcon A for astigmatism
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)	55 Participants	46 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Two to four weeks after fit with optimized prescription (Habitual lens) or two weeks after refit (Delefilcon A)

Outcome measures

Outcome measures
Measure	Habitual Lens n=85 Participants New habitual toric lenses with an optimized prescription	Delefilcon A n=85 Participants Refit with delefilcon A for astigmatism
Hours of Comfortable Wear	9.0 hours Standard Deviation 4.8	8.0 hours Standard Deviation 4.1

OTHER_PRE_SPECIFIED outcome

Timeframe: Two to four weeks after fit with optimized prescription (Habitual lens) or two weeks after refit (Delefilcon A)

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Two to four weeks after fit with optimized prescription (Habitual lens) or two weeks after refit (Delefilcon A)

Outcome measures

Outcome measures
Measure	Habitual Lens n=85 Participants New habitual toric lenses with an optimized prescription	Delefilcon A n=85 Participants Refit with delefilcon A for astigmatism
Binocular Contact Lens Corrected Visual Acuity at Distance (6m)	0.00 logMAR Standard Deviation 0.09	0.05 logMAR Standard Deviation 0.12

Adverse Events

Bilateral Use of 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 Keith Wan

Scripps Optometric Group

Phone: 858-530-2800

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place