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Total30 for Astigmatism Contact Lenses

Primary Purpose

Contact Lens Complication, Astigmatism, Refractive Errors

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
TOTAL30 for Astigmatism Contact Lenses
Sponsored by
Southern College of Optometry
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Contact Lens Complication focused on measuring TOTAL30 for Astigmatism, Comfort, Dryness, Visual Analog Scale, Contact Lens

Eligibility Criteria

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

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

Sites / Locations

  • Kannarr Eye Care
  • Coldwater VIsion Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Total30 for Astigmatism Contact Lenses

Arm Description

TOTAL30 for Astigmatism Monthly Replacement Contact Lenses

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Full Information

First Posted
September 18, 2023
Last Updated
September 18, 2023
Sponsor
Southern College of Optometry
Collaborators
Alcon Research
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1. Study Identification

Unique Protocol Identification Number
NCT06052046
Brief Title
Total30 for Astigmatism Contact Lenses
Official Title
How Does Total30 for Astigmatism Perform During a Long Day of Wear?
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 20, 2023 (Anticipated)
Primary Completion Date
May 11, 2024 (Anticipated)
Study Completion Date
June 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Southern College of Optometry
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
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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Contact Lens Complication, Astigmatism, Refractive Errors
Keywords
TOTAL30 for Astigmatism, Comfort, Dryness, Visual Analog Scale, Contact Lens

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 for Astigmatism Contact Lenses.
Masking
None (Open Label)
Allocation
N/A
Enrollment
48 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Total30 for Astigmatism Contact Lenses
Arm Type
Experimental
Arm Description
TOTAL30 for Astigmatism Monthly Replacement Contact Lenses
Intervention Type
Device
Intervention Name(s)
TOTAL30 for Astigmatism Contact Lenses
Other Intervention Name(s)
Lehfilcon A
Intervention Description
Participants will be refit into TOTAL30 for Astigmatism Contact Lenses and followed for 1 month.
Primary Outcome Measure Information:
Title
Visual Analog Scale (VAS) Comfort Scores
Description
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).
Time Frame
Change from baseline at 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: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Randy Brafford, BS
Phone
901.252.3660
Email
rbrafford@sco.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Quentin X Franklin, BS, BA
Phone
6592064188
Email
QuentinFranklin@uab.edu
Facility Information:
Facility Name
Kannarr Eye Care
City
Pittsburg
State/Province
Kansas
ZIP/Postal Code
66762
Country
United States
Facility Name
Coldwater VIsion Center
City
Coldwater
State/Province
Mississippi
ZIP/Postal Code
38618
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kristopher May, OD
Phone
662-224-8000

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Summary data will be published in a peer-reviewed manuscript.

Learn more about this trial

Total30 for Astigmatism Contact Lenses

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