Total30 for Astigmatism Contact Lenses

Sponsor

Southern College of Optometry (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06052046

Collaborator

Alcon Research (Industry)

Enrollment

Locations

Arm

8.4

Anticipated Duration (Months)

Patients Per Site

2.9

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Contact Lens Complication Astigmatism Refractive Errors	Device: TOTAL30 for Astigmatism Contact Lenses	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

48 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

This prospective, one-month, three-visit study will refit all participants into TOTAL30 for Astigmatism Contact Lenses.This prospective, one-month, three-visit study will refit all participants into TOTAL30 for Astigmatism Contact Lenses.

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

How Does Total30 for Astigmatism Perform During a Long Day of Wear?

Anticipated Study Start Date :

Sep 20, 2023

Anticipated Primary Completion Date :

May 11, 2024

Anticipated Study Completion Date :

Jun 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Total30 for Astigmatism Contact Lenses TOTAL30 for Astigmatism Monthly Replacement Contact Lenses	Device: TOTAL30 for Astigmatism Contact Lenses Participants will be refit into TOTAL30 for Astigmatism Contact Lenses and followed for 1 month. Other Names: Lehfilcon A

Arm

Intervention/Treatment

Experimental: Total30 for Astigmatism Contact Lenses

TOTAL30 for Astigmatism Monthly Replacement Contact Lenses

Device: TOTAL30 for Astigmatism Contact Lenses

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

Other Names:

Lehfilcon A

Outcome Measures

Primary Outcome Measures

Visual Analog Scale (VAS) Comfort Scores [Change from baseline at 1 month]
A VAS will be used to compare end of day ocular comfort at about 16 hours of contact lens wear (± 50 scale with +50 being best possible comfort and -50 being worst possible comfort).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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