Total30 Sphere Contact Lenses

Do Total 30 Sphere Contact Lenses Provide a Comfortable Wearing Experience All Day?

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 Sphere CLs.

Study Overview

• Status: Completed
• Conditions: Dry Eye; Contact Lens Complication
• Intervention / Treatment: Device: Total30 Sphere Contact Lenses

Detailed Description

Contact lens (CL) wearers frequently face eye discomfort symptoms, especially 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 Sphere 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 Sphere CLs. These data are not only important for judging the performance of Total30 Sphere CLs, but they will provide some of the first insights into the full day CL wearing experience over one month.

• Study Type: Interventional
• Enrollment (Actual): 48
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294
      • University of Alabama at Birmingham
    • Birmingham, Alabama, United States, 35213
      • University of Alabama at Birmingham

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Current contact lens wearers who have 20/20 visual acuity or better
• Minimally symptomatic as based upon Contact Lens Dry Eye Questionnaire scores (≤10)
• Astigmatism better than or equal to 0.50 D in each eye
• Must have regularly worn 2 week or monthly contact lenses within the past 6 months
• Must provide a glasses prescription that is is less than 3 years old
• Willing to start wearing their contact lenses between 6:00 AM and 8:00 AM and wear their contact lenses until 11:00 PM each day

Exclusion Criteria:

• Past or Current hard CL use
• Any known systemic health conditions that are thought to alter tear film physiology
• History of viral eye disease
• History of ocular surgery
• History of severe ocular trauma
• Active ocular infection or inflammation
• Currently using isotretinoin-derivatives
• Currently using ocular medications
• Currently using rewetting drops or artificial tear
• Pregnant or breast feeding

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 Sphere Contact Lenses; All qualified participants will be refit into Total30 Sphere contact lenses.	Device: Total30 Sphere Contact Lenses; Participants will be refit into Total30 Sphere 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) Ocular Comfort	A visual analog scale (VAS) was used to compare end of day ocular comfort at 16 hours of contact lens wear over the 1 month study (0 to 100 scale with 100 being best).	1 month

Collaborators and Investigators

• Sponsor: University of Alabama at Birmingham
• Collaborators: Alcon Research
• Investigators: Principal Investigator: Andrew D Pucker, OD, MS, PhD, University of Alabama at Birmingham

Study record dates

Study Major Dates

• Study Start (Actual): January 3, 2022
• Primary Completion (Actual): July 20, 2022
• Study Completion (Actual): July 20, 2022

Study Registration Dates

• First Submitted: December 20, 2021
• First Submitted That Met QC Criteria: December 20, 2021
• First Posted (Actual): January 10, 2022

Study Record Updates

• Last Update Posted (Actual): December 16, 2022
• Last Update Submitted That Met QC Criteria: November 19, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: Total30 Sphere Contact Lenses; Comfort; Dryness; Visual Analog Scale Scores
• Additional Relevant MeSH Terms: Eye Diseases; Lacrimal Apparatus Diseases; Dry Eye Syndromes
• Other Study ID Numbers: IRB-300008004

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

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