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

Astigmatism Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05938010
• Other study ID #: JM-23-01
• Status: Completed
• Start date: July 25, 2023
• Est. completion date: September 26, 2023

Study information

• Verified date: January 2024
• Source: Scripps Poway Eyecare and Optometry
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: September 26, 2023
• Est. primary completion date: September 26, 2023
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Astigmatism

Intervention

Device:
• Dailies Total1® contact lenses for astigmatism (T30fA)
Dailies Total1® contact lenses for astigmatism (T30fA)

Locations

Country	Name	City	State
United States	Scripps Poway Eyecare & Optometry	San Diego	California

Sponsors (2)

Lead Sponsor	Collaborator
Scripps Poway Eyecare and Optometry	Sengi

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	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
Other	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
Primary	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