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

Completed

• Conditions: Astigmatism
• Interventions: Device: DT1fA

• Registration Number: NCT05498649
• Lead Sponsor: Keith Wan

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.

Study Timeline

• Study Start: 2022-08-02
• Study First Submitted: 2022-08-10
• Study First Submitted QC: 2022-08-10
• Study First Posted: 2022-08-12
• Primary Completion: 2022-12-16
• Study Completion: 2022-12-16
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-09
• Last Update Posted: 2023-02-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 86

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 exclusion criteria are applicable to the subject or either eye, the subject should not be enrolled in the study.

• Ocular anterior segment infection, inflammation, abnormality, or active disease including diagnosed dry eye, that would contraindicate contact lens wear
• Use of systemic or ocular medications for which contact lens wear could be contraindicated as determined by the Investigator
• Monocular (only 1 eye with functional vision) or fit with only 1 lens
• Fitted with monovision
• Prior Refractive Surgery
• History of herpetic keratitis, ocular surgery, or irregular cornea
• Pregnant or lactating

The principal investigator reserves the right to declare a patient ineligible or non-evaluable based on medical evidence that indicates they are unsuitable for the trial.

Pregnancy has a known effect on the stability of refractions and visual acuity. As such, subjects who become pregnant during the study will not be discontinued but their data may be excluded from analyses of effectiveness.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Bilateral use of DT1fA contact lenses	DT1fA	DT1fA contact lenses

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Scripps Poway Eyecare & Optometry; 🇺🇸 San Diego, California, United States