Performance of Dailies Total1® Contact Lenses for Astigmatism in Symptomatic Habitual Reusable Toric Lens Wearers

NCT05498649 | Completed Results FDA Device

• 1 other identifier: KW-22-001
• Study Type: observational
• Target: 86
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Astigmatism

Outcome Measures

Primary Outcomes (1)

• Contact Lens Dry Eye Questionnaire (CLDEQ-8) Score

  A series of 8 questions that ask participants to rate eye discomfort, eye dryness, and blurry vision on a frequency scale (0 Never, 1 Rarely, 2 Sometimes, 3 Frequently, 4 Constantly) and an intensity scale (0 Never, 1 not intense to 5 Very Intense). Scores on individual questions are added together to determine a total score. Higher values indicate worse outcomes. The minimum score is 1 and the maximum score is 37.

  Two to four weeks after fit with optimized prescription (Habitual lens) or two weeks after refit (Delefilcon A)

Other Outcomes (6)

• 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)

  Two to four weeks after fit with optimized prescription (Habitual lens) or two weeks after refit (Delefilcon A)

• 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)

  Two to four weeks after fit with optimized prescription (Habitual lens) or two weeks after refit (Delefilcon A)

• 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)

  Two to four weeks after fit with optimized prescription (Habitual lens) or two weeks after refit (Delefilcon A)

Study Arms (1)

Bilateral use of DT1fA contact lenses

DT1fA contact lenses

Device: DT1fA

Interventions

DT1fA DEVICE

DT1fA contact lenses

Bilateral use of DT1fA contact lenses

Eligibility Criteria

• Age: 18 Years - 38 Years
• Sex: all
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Keith Wan: 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 Keith Wan
• Organization: Scripps Optometric Group

keithmwan@gmail.com

858-530-2800

Study Officials

• Keith Wan, 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 INVESTIGATOR
• PI Title: Optometrist

Study Record Dates

• First Submitted: August 10, 2022
• First Posted: August 12, 2022
• Study Start: August 2, 2022
• Primary Completion: December 16, 2022
• Study Completion: December 16, 2022
• Last Updated: September 19, 2024
• Results First Posted: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)