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

NCT05938010 | Completed Results FDA Device

• 1 other identifier: JM-23-01
• Study Type: observational
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Astigmatism

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Satisfaction With Visual Performance of T30fA Lens

  After 1 month of wear

• Satisfaction With End of Day Comfort of T30fA Lens

  After 1 month of wear

• Satisfaction With Ease of Handling of T30fA Lens

  After 1 month of wear

Study Arms (1)

Dailies Total1® contact lenses for astigmatism (T30fA)

Dailies Total1® contact lenses for astigmatism (T30fA)

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

Interventions

Dailies Total1® contact lenses for astigmatism (T30fA) DEVICE

Dailies Total1® contact lenses for astigmatism (T30fA)

Dailies Total1® contact lenses for astigmatism (T30fA)

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Scripps Poway Eyecare and Optometry: lead
• Sengi: collaborator

Study Sites (1)

Scripps Poway Eyecare & Optometry

San Diego, California, 92131, United States

Location

MeSH Terms

Conditions

Astigmatism

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Results Point of Contact

• Title: Dr Jay Mashouf
• Organization: Scripps Optometric Group

jaymashouf@gmail.com

1-858-530-2800

Study Officials

• Jay Mashouf, OD

  Scripps Poway Eyecare & Optometry

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 30, 2023
• First Posted: July 10, 2023
• Study Start: July 25, 2023
• Primary Completion: September 26, 2023
• Study Completion: September 26, 2023
• Last Updated: November 14, 2024
• Results First Posted: November 14, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)