Total30 for Astigmatism Contact Lenses

NCT ID: NCT06052046

Last Updated: 2025-02-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-15
• Study Completion Date: 2024-06-01

Brief Summary

Determine if Total30 for Astigmatism contact lenses (CLs) provide a comfortable wearing experience all day. CL discomfort affects most CL wearers with discomfort consistently topping the reasons why established CL wearers drop out of CLs. In fact, studies have consistently found that the frequency of CL dropout is around 20% with this dropout frequency staying relatively stable over the past 20 plus years. This static frequency of CL dropout is surprising since there have been a number of dramatic soft CL innovations during this time frame (e.g., widely available daily disposable CLs, silicone hydrogel CL materials with high oxygen transmissibility, new CL surface coatings).

Detailed Description

A common issues that contact lens (CL) wearers frequently face is that their discomfort symptoms increase towards the end of the wear day. This burdensome discomfort can unfortunately cause patients to remove their CLs before their desired wear time. While comfortable wear times vary from patient to patient, Terry et al. has suggested that patients should be able to comfortably wear their CLs for at least 12 hours per day for at least 6 days per week. Nevertheless, the literature currently lacks sufficient data to comment fully on the full day wear experience, which for many patients may be 16 or more hours per day, especially if they have demanding careers. One CL that has the potential to allow for all day comfort is the Total30 for Astigmatism CLs, which is a new water gradient, monthly CL aimed at delivering all day comfort and visual performance. Thus, the purpose of this study is to map comfort over the full wear day in established, asymptomatic, soft CL wearers who are refit in Total30 for Astigmatism CLs. These data are not only important for judging the performance of Total30 for Astigmatism CLs, but they will provide some of the first insights into the full day CL wearing experience over one month.

Conditions

Contact Lens Complication; Astigmatism; Refractive Errors

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Total30 for Astigmatism Contact Lenses

TOTAL30 for Astigmatism Monthly Replacement Contact Lenses

Group Type: EXPERIMENTAL

TOTAL30 for Astigmatism Contact Lenses

Intervention Type: DEVICE

Participants will be refit into TOTAL30 for Astigmatism Contact Lenses and followed for 1 month.

Interventions

TOTAL30 for Astigmatism Contact Lenses

Participants will be refit into TOTAL30 for Astigmatism Contact Lenses and followed for 1 month.

Intervention Type: DEVICE

Other Intervention Names

Lehfilcon A

Eligibility Criteria

Inclusion Criteria

• 18- to 45-year-old
• Visual acuity 20/20 or better
• Contact Lens Dry Eye Questionnaire [CLDEQ]-8 scores <10
• Willing to wear Total30 for Astigmatism CLs
• Have a smart phone with text messaging capabilities
• Astigmatism ranging from 0.75 D to 2.50 D in each eye
• Regularly worn 2 week or monthly CLs within the past 6 months
• Current CL wearer
• Glasses prescription that is less than 2 years old
• Willing to start wearing their CLs between 6:00 AM and 8:00 AM and wear their CLs until 11:00 PM each day text messaging data is collected

Exclusion Criteria

• Current or past hard CL wearers
• A known systemic health condition that is thought to alter tear film physiology
• A history of viral eye disease
• A history of ocular surgery
• A history of severe ocular trauma
• Have an active ocular infection or inflammation
• Currently using isotretinoin-derivatives or ocular medications
• Currently using rewetting drops or artificial tears
• Pregnant or breast feeding
• Willing to discontinue usage of current toric CLs one week prior to the initial visit

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Alcon Research

INDUSTRY

Sponsor Role: collaborator

Southern College of Optometry

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Kannarr Eye Care

Pittsburg, Kansas, United States

Coldwater VIsion Center

Coldwater, Mississippi, United States

Countries

United States

References

Lievens C, Perkins A, Rayborn E, Wang Y, Franklin Q, May K, Kannarr S, Bromley M, Pucker AD. Real-Time Changes in the Comfort of a Toric, Monthly, Soft Contact Lens Over a Long Day of Wear. Clin Optom (Auckl). 2024 Dec 17;16:317-325. doi: 10.2147/OPTO.S490934. eCollection 2024.

Reference Type: DERIVED

PMID: 39713278 (View on PubMed)

Other Identifiers

IRB-00006733

Identifier Type: -

Identifier Source: org_study_id