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

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

Study Overview

• Status: Completed
• Conditions: Astigmatism
• Intervention / Treatment: Device: DT1fA

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 Type: Observational
• Enrollment (Actual): 86

Contacts and Locations

Study Locations

• United States
  • California
    • San Diego, California, United States, 92131
      • Scripps Poway Eyecare & Optometry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 38 years (ADULT)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Eligible participants will be 18-38 years of age who are current and appropriate candidates for contact lens wear.

Description

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 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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Bilateral use of DT1fA contact lenses; DT1fA contact lenses	Device: DT1fA; DT1fA contact lenses

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
CLDEQ-8 Questionnaire Score	two weeks after refit

Other Outcome Measures

Outcome Measure	Time Frame
Differences between baseline and 2 weeks of DT1fA wear for end of day (EOD) discomfort score	two weeks after refit
EOD dryness score	two weeks after refit
EOD vision score	two weeks after refit
Hours of comfortable wear	two weeks after refit
Vision stability	two weeks after refit
Binocular contact lens corrected visual acuity at distance (6m)	two weeks after refit

Collaborators and Investigators

• Sponsor: Keith Wan
• Collaborators: Sengi

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 2, 2022
• Primary Completion (ACTUAL): December 16, 2022
• Study Completion (ACTUAL): December 16, 2022

Study Registration Dates

• First Submitted: August 10, 2022
• First Submitted That Met QC Criteria: August 10, 2022
• First Posted (ACTUAL): August 12, 2022

Study Record Updates

• Last Update Posted (ACTUAL): February 10, 2023
• Last Update Submitted That Met QC Criteria: February 9, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Astigmatism
• Other Study ID Numbers: KW-22-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes