Clinical trial NCT05498649: Performance of Dailies Total1® Contact Lenses for Astigmatism in Symptomatic Habitual Reusable Toric Lens Wearers
Official title: Performance of Dailies Total1® Contact Lenses for Astigmatism in Symptomatic Habitual Reusable 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: 2022-08-12
Enrollment: 86
Sex: ALL
Minimum age (years): 18
Maximum age (years): 38
Standard ages: ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Eligible participants will be 18-38 years of age who are current and appropriate candidates for contact lens wear.

Brief summary: To subjectively evaluate Dailies Total1® contact lenses for astigmatism (DT1fA) performance compared to other common weekly/monthly contact lenses in symptomatic patients.

Detailed description: This study is a single site, prospective, subject-masked, observational study of the subjective performance of DT1fA 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: Subjects are eligible for the study if they meet the following criteria:

Note: Ocular criteria must be met in both eyes.

Inclusion Criteria:

* Willing and able to provide informed consent
* Adult (18-38 years of age)
* Adapted and optimized current reusable soft toric lens wearer who has at least 3 months of wearing experience, and typically wears lenses every day, or at least 5 days per week, ≥10 hours per day
* Prescription needs with sphere and cylinder values that can be appropriately fit with current available parameters in the Dailies Total1® Contact lenses for Astigmatism product line
* Vision correctable to 20/25 Snellen (0.1 logMAR) or better in each eye at 6m
* Willing to wear lenses every day or at least 5 days per week, 10 or more hours per day and attend all study visits and follow instructions
* CLDEQ-8 minimum score of 12

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 including diagnosed dry eye, that would contraindicate contact lens wear
* Use of systemic or ocular medications for which contact lens wear could be contraindicated as determined by the Investigator
* Monocular (only 1 eye with functional vision) or fit with only 1 lens
* Fitted with monovision
* Prior Refractive 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: Contact Lens Dry Eye Questionnaire (CLDEQ-8) Score
timeFrame: Two to four weeks after fit with optimized prescription (Habitual lens) or two weeks after refit (Delefilcon A)
Secondary outcomes:
Other outcomes:
measure: The Percentage of Participants That Reported Little to no Intensity of Eye Discomfort at Baseline and 2 Weeks of DT1fA Wear for End of Day (EOD)
timeFrame: Two to four weeks after fit with optimized prescription (Habitual lens) or two weeks after refit (Delefilcon A)
measure: The Percentage of Participants That Reported Little to no Intensity of Eye Dryness at Baseline and 2 Weeks of DT1fA Wear for End of Day (EOD)
timeFrame: Two to four weeks after fit with optimized prescription (Habitual lens) or two weeks after refit (Delefilcon A)
measure: The Percentage of Participants That Reported Little to no Noticeable Change Between Clear to Blurry or Foggy Vision at Baseline and 2 Weeks of DT1fA Wear for End of Day (EOD)
timeFrame: Two to four weeks after fit with optimized prescription (Habitual lens) or two weeks after refit (Delefilcon A)
measure: Hours of Comfortable Wear
timeFrame: Two to four weeks after fit with optimized prescription (Habitual lens) or two weeks after refit (Delefilcon A)
measure: Vision Stability
timeFrame: Two to four weeks after fit with optimized prescription (Habitual lens) or two weeks after refit (Delefilcon A)
measure: Binocular Contact Lens Corrected Visual Acuity at Distance (6m)
timeFrame: Two to four weeks after fit with optimized prescription (Habitual lens) or two weeks after refit (Delefilcon A)
Locations:
city: San Diego
country: United States
facility: Scripps Poway Eyecare & Optometry
state: California
Study officials:
affiliation: Scripps Poway Eyecare & Optometry
name: Keith Wan, OD
role: PRINCIPAL_INVESTIGATOR
References: