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

Astigmatism Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05498649
• Other study ID #: KW-22-001
• Status: Completed
• Start date: August 2, 2022
• Est. completion date: December 16, 2022

Study information

• Verified date: February 2023
• Source: Scripps Poway Eyecare and Optometry
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 86
• Est. completion date: December 16, 2022
• Est. primary completion date: December 16, 2022
• Gender: All
• Age group: 18 Years to 38 Years

Eligibility

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.

Related Conditions & MeSH terms

• Astigmatism

Intervention

Device:
• DT1fA
DT1fA contact lenses

Locations

Country	Name	City	State
United States	Scripps Poway Eyecare & Optometry	San Diego	California

Sponsors (2)

Lead Sponsor	Collaborator
Keith Wan	Sengi

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Differences between baseline and 2 weeks of DT1fA wear for end of day (EOD) discomfort score		two weeks after refit
Other	EOD dryness score		two weeks after refit
Other	EOD vision score		two weeks after refit
Other	Hours of comfortable wear		two weeks after refit
Other	Vision stability		two weeks after refit
Other	Binocular contact lens corrected visual acuity at distance (6m)		two weeks after refit
Primary	CLDEQ-8 Questionnaire Score		two weeks after refit