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OpenTrials
Completed

NCT Number: NCT05938010

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.

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Key information

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Scripps Poway Eyecare & Optometry

San Diego, California, 92131, United States

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Dailies Total1® contact lenses for astigmatism (T30fA)

Device

Dailies Total1® contact lenses for astigmatism (T30fA)

Primary outcomes

  1. Satisfaction With Comfort of T30fA Lens

    Time frame: 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.

Other outcomes

  1. Satisfaction With Visual Performance of T30fA Lens

    Time frame: 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.

  2. Satisfaction With End of Day Comfort of T30fA Lens

    Time frame: 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.

  3. Satisfaction With Ease of Handling of T30fA Lens

    Time frame: 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.

  4. Satisfaction Overall of Handling of T30fA Lens

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Scripps Poway Eyecare and Optometry

Other

Collaborators

  • Sengi

Registry information

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Jul 10, 2023
Registry last updated
Nov 14, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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