Total30 for Astigmatism Contact Lenses

Astigmatism Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06052046
• Other study ID #: IRB-00006733
• Status: Recruiting
• Phase: N/A
• Start date: October 15, 2023
• Est. completion date: June 1, 2024

Study information

• Verified date: November 2023
• Source: Southern College of Optometry
• Contact: Randy Brafford, BS
• Phone: 901.252.3660
• Email: rbrafford[@]sco.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 48
• Est. completion date: June 1, 2024
• Est. primary completion date: May 11, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Astigmatism
• Contact Lens Complication
• Refractive Errors

Intervention

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

Locations

Country	Name	City	State
United States	Coldwater VIsion Center	Coldwater	Mississippi
United States	Kannarr Eye Care	Pittsburg	Kansas

Sponsors (2)

Lead Sponsor	Collaborator
Southern College of Optometry	Alcon Research

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual Analog Scale (VAS) Comfort Scores	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).	Change from baseline at 1 month