Clinical trial NCT05938010: Subjective Wearing Experience of the Total30 for Astigmatism Lens Among Satisfied Biofinity Toric Lens Wearers
Official title: Subjective Wearing Experience of the Total30 for Astigmatism Lens Among Satisfied Biofinity Toric Lens Wearers
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Astigmatism
Lead sponsor: Scripps Poway Eyecare and Optometry
Sponsor class: OTHER
Collaborators: name: Sengi
First posted: 2023-07-10
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Satisfaction With Comfort of T30fA Lens
timeFrame: After 1 month of wear
Secondary outcomes:
Other outcomes:
measure: Satisfaction With Visual Performance of T30fA Lens
timeFrame: After 1 month of wear
measure: Satisfaction With End of Day Comfort of T30fA Lens
timeFrame: After 1 month of wear
measure: Satisfaction With Ease of Handling of T30fA Lens
timeFrame: After 1 month of wear
measure: Satisfaction Overall of Handling of T30fA Lens
timeFrame: After 1 month of wear
Locations:
city: San Diego
country: United States
facility: Scripps Poway Eyecare & Optometry
state: California
Study officials:
affiliation: Scripps Poway Eyecare & Optometry
name: Jay Mashouf, OD
role: PRINCIPAL_INVESTIGATOR
References: