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

NCT ID: NCT05498649

Last Updated: 2024-09-19

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 86 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-08-02
• Study Completion Date: 2022-12-16

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.

Conditions

Astigmatism

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Bilateral use of DT1fA contact lenses

DT1fA contact lenses

DT1fA

Intervention Type: DEVICE

DT1fA contact lenses

Interventions

DT1fA

DT1fA contact lenses

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

Note: Ocular criteria must be met in both eyes.

• 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

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 38 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sengi

INDUSTRY

Sponsor Role: collaborator

Keith Wan

OTHER

Sponsor Role: lead

Responsible Party

Keith Wan

Optometrist

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Keith Wan, OD

Role: PRINCIPAL_INVESTIGATOR

Scripps Poway Eyecare & Optometry

Locations

Scripps Poway Eyecare & Optometry

San Diego, California, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

KW-22-001

Identifier Type: -

Identifier Source: org_study_id