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

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

Study Overview

• Status: Completed
• Conditions: Astigmatism
• Intervention / Treatment: Device: Dailies Total1® contact lenses for astigmatism (T30fA)

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.

• Study Type: Observational
• Enrollment (Actual): 42

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: Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

Eligible participants will be 18-45 years of age who are current Biofinity Toric wearers and appropriate candidates for contact lens wear.

Description

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:

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 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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Dailies Total1® contact lenses for astigmatism (T30fA)	Device: Dailies Total1® contact lenses for astigmatism (T30fA); Dailies Total1® contact lenses for astigmatism (T30fA)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Satisfaction with comfort of T30fA lens	Subjects will give a rating between 0 and 10 (with 0 indicating not satisfactory at all and 10 indicating extremely satisfactory) best describing their comfort.	After 1 month of wear

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Satisfaction with visual performance of T30fA lens	Subjects will give a rating between 0 and 10 (with 0 indicating not satisfactory at all and 10 indicating extremely satisfactory) best describing their comfort.	After 1 month of wear
Satisfaction with end of day comfort of T30fA lens	Subjects will give a rating between 0 and 10 (with 0 indicating not satisfactory at all and 10 indicating extremely satisfactory) best describing their comfort.	After 1 month of wear
Satisfaction with ease of handling of T30fA lens	Subjects will give a rating between 0 and 10 (with 0 indicating not satisfactory at all and 10 indicating extremely satisfactory) best describing their comfort.	After 1 month of wear
Satisfaction overall of handling of T30fA lens	Subjects will give a rating between 0 and 10 (with 0 indicating not satisfactory at all and 10 indicating extremely satisfactory) best describing their comfort.	After 1 month of wear

Collaborators and Investigators

• Sponsor: Scripps Poway Eyecare and Optometry
• Collaborators: Sengi
• Investigators: Principal Investigator: Jay Mashouf, OD, Scripps Poway Eyecare & Optometry

Study record dates

Study Major Dates

• Study Start (Actual): July 25, 2023
• Primary Completion (Actual): September 26, 2023
• Study Completion (Actual): September 26, 2023

Study Registration Dates

• First Submitted: June 30, 2023
• First Submitted That Met QC Criteria: June 30, 2023
• First Posted (Actual): July 10, 2023

Study Record Updates

• Last Update Posted (Actual): January 5, 2024
• Last Update Submitted That Met QC Criteria: January 3, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Astigmatism
• Other Study ID Numbers: JM-23-01

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
• product manufactured in and exported from the U.S.: Yes