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Total30 Sphere Contact Lenses

Primary Purpose

Contact Lens Complication, Dry Eye

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Total30 Sphere Contact Lenses
Sponsored by
University of Alabama at Birmingham
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Contact Lens Complication focused on measuring Total30 Sphere Contact Lenses; Comfort; Dryness; Visual Analog Scale Scores

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of Alabama at Birmingham
  • University of Alabama at Birmingham

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Total30 Sphere Contact Lenses

Arm Description

All qualified participants will be refit into Total30 Sphere contact lenses.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Full Information

First Posted
December 20, 2021
Last Updated
November 19, 2022
Sponsor
University of Alabama at Birmingham
Collaborators
Alcon Research
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1. Study Identification

Unique Protocol Identification Number
NCT05183022
Brief Title
Total30 Sphere Contact Lenses
Official Title
Do Total 30 Sphere Contact Lenses Provide a Comfortable Wearing Experience All Day?
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
January 3, 2022 (Actual)
Primary Completion Date
July 20, 2022 (Actual)
Study Completion Date
July 20, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alabama at Birmingham
Collaborators
Alcon Research

4. Oversight

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

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Contact Lens Complication, Dry Eye
Keywords
Total30 Sphere Contact Lenses; Comfort; Dryness; Visual Analog Scale Scores

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
This prospective, one-month, three-visit study will refit all participants into Total30 Sphere contact lenses.
Masking
None (Open Label)
Allocation
N/A
Enrollment
48 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Total30 Sphere Contact Lenses
Arm Type
Experimental
Arm Description
All qualified participants will be refit into Total30 Sphere contact lenses.
Intervention Type
Device
Intervention Name(s)
Total30 Sphere Contact Lenses
Other Intervention Name(s)
Lehfilcon A
Intervention Description
Participants will be refit into Total30 Sphere contact lenses and followed for 1 month.
Primary Outcome Measure Information:
Title
Visual Analog Scale (VAS) Ocular Comfort
Description
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).
Time Frame
1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrew D Pucker, OD, MS, PhD
Organizational Affiliation
University of Alabama at Birmingham
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35213
Country
United States
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Total30 Sphere Contact Lenses

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