Total30 for Astigmatism Contact Lenses

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

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).

Study Overview

• Status: Recruiting
• Conditions: Refractive Errors; Astigmatism; Contact Lens Complication
• Intervention / Treatment: Device: TOTAL30 for Astigmatism Contact Lenses

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 Type: Interventional
• Enrollment (Estimated): 48
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Randy Brafford, BS; Phone Number: 901.252.3660; Email: rbrafford@sco.edu
• Study Contact Backup: Name: Quentin X Franklin, BS, BA; Phone Number: 6592064188; Email: QuentinFranklin@uab.edu

Study Locations

• United States
  • Kansas
    • Pittsburg, Kansas, United States, 66762
      • Recruiting
      • Kannarr Eye Care
  • Mississippi
    • Coldwater, Mississippi, United States, 38618
      • Recruiting
      • Coldwater VIsion Center
      • Contact: Kristopher May, OD; Phone Number: 662-224-8000

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Southern College of Optometry
• Collaborators: Alcon Research

Study record dates

Study Major Dates

• Study Start (Actual): October 15, 2023
• Primary Completion (Estimated): May 11, 2024
• Study Completion (Estimated): June 1, 2024

Study Registration Dates

• First Submitted: September 18, 2023
• First Submitted That Met QC Criteria: September 18, 2023
• First Posted (Actual): September 25, 2023

Study Record Updates

• Last Update Posted (Actual): November 22, 2023
• Last Update Submitted That Met QC Criteria: November 21, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Visual Analog Scale; Comfort; Contact Lens; Dryness; TOTAL30 for Astigmatism
• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Astigmatism
• Other Study ID Numbers: IRB-00006733

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Summary data will be published in a peer-reviewed manuscript.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes