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

Completed

• Conditions: Astigmatism

• Registration Number: NCT05938010
• Lead Sponsor: Scripps Poway Eyecare and Optometry

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.

Study Timeline

• Study First Submitted: 2023-06-30
• Study First Submitted QC: 2023-06-30
• Study First Posted: 2023-07-10
• Study Start: 2023-07-25
• Primary Completion: 2023-09-26
• Study Completion: 2023-09-26
• Status Verified: 2024-08
• Results First Submitted: 2024-08-28
• Results First Submitted QC: 2024-08-28
• Last Update Submitted: 2024-08-28
• Results First Posted: 2024-11-14
• Last Update Posted: 2024-11-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Satisfaction With Comfort of T30fA Lens	After 1 month of wear	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.

Trial Locations

Locations (1)

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