Subjective Wearing Experience of the Total30 for Astigmatism Lens Among Satisfied Biofinity Toric Lens Wearers

NCT ID: NCT05938010

Last Updated: 2024-11-14

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 42 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-07-25
• Study Completion Date: 2023-09-26

Brief Summary

To subjectively evaluate wearing experience in the T30fA lens among subjects who were already satisfied with their Biofinity Toric lenses.

Detailed Description

This study is a single site, prospective, observational study of the subjective performance of T30fA 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

Dailies Total1® contact lenses for astigmatism (T30fA)

Dailies Total1® contact lenses for astigmatism (T30fA)

Dailies Total1® contact lenses for astigmatism (T30fA)

Intervention Type: DEVICE

Dailies Total1® contact lenses for astigmatism (T30fA)

Interventions

Dailies Total1® contact lenses for astigmatism (T30fA)

Dailies Total1® contact lenses for astigmatism (T30fA)

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

Subjects are eligible for the study if they meet the following criteria:

Note: Ocular criteria must be met in both eyes.

• Subjects who are currently wearing and can answer in the affirmative the following question: "I am satisfied with my current Biofinity toric monthly replacement lenses" prior to and after habitual lens optimization.
• Subjects between the ages of 18-45 who wear their Biofinity Toric lenses at least 5 days per week, at least 10 hours per day.
• Prescription with a sphere value between +4.00D and -6.00D inclusive, and a cylinder value between -0.75D and -2.25D.
• Vision Correctable to 20/20 (0.0 logMAR) or better in each eye at 6M with their Manifest refraction.
• Willing to attend all study visits.

Exclusion Criteria

• Ocular anterior segment infection, inflammation, abnormality, or active disease that would contraindicate contact lens wear.
• Use of systemic or ocular medications for which contact lens wear could be contraindicated as determined the investigator.
• Monocular (only 1 eye with functional vision) or fit with only 1 lens (and those patients that cannot be successfully fit with the T30fA lens design).
• Fitted with monovision.
• Prior ocular 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: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sengi

INDUSTRY

Sponsor Role: collaborator

Scripps Poway Eyecare and Optometry

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jay Mashouf, 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

JM-23-01

Identifier Type: -

Identifier Source: org_study_id