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Dailies Total 1 Sphere Contact Lenses

Primary Purpose

Dry Eye, Contact Lens Complication

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
DT1 Sphere Contact Lenses
Sponsored by
University of Alabama at Birmingham
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Dry Eye focused on measuring Contact Lens, Dailies Total1, Dry Eye, Comfort

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Adults 18-40
  • Past contact lens wearers who have best corrected 20/20 visual acuity or better
  • Participants will have had to have worn contact lenses for at least 1 year in the past
  • Dropped out of contact lenses in the past 2 years do to discomfort or dryness
  • Scores of 3 or less on the SPEED questionnaire
  • Be able to be refit into Dailies Total1 Sphere contact lenses
  • Provide a glasses prescription that is less than 3-years-old

Exclusion Criteria:

  • Past rigid contact lens wearers
  • A past history of being diagnosed with dry eye or ocular allergies
  • Known systemic health conditions that are known to alter tear film physiology
  • History of viral eye disease
  • History of ocular surgery
  • History of severe ocular trauma
  • History of corneal dystrophies or degeneration
  • Having active ocular infection or inflammation
  • Currently using isotretinoin-derivatives or ocular medication
  • Pregnant or breast feeding

Sites / Locations

  • University of Alabama at Birmingham
  • Kannarr Eye Care
  • ProCare Vision Center
  • The Southern College of Optometry

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Dailies Total1

Arm Description

All participants will be asked to wear Dailies Total1 for the duration of this study.

Outcomes

Primary Outcome Measures

Visual Analog Scale (VAS) Contact Lenses Comfort Scores
The frequency of participants who have comfortable (positive) visual analog scale (VAS) scores at both the 1-month (-50 to +50 scale with scores greater than 0 being comfortable).

Secondary Outcome Measures

Full Information

First Posted
February 4, 2022
Last Updated
September 7, 2023
Sponsor
University of Alabama at Birmingham
Collaborators
Alcon Research
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1. Study Identification

Unique Protocol Identification Number
NCT05239494
Brief Title
Dailies Total 1 Sphere Contact Lenses
Official Title
How Does DT1 Sphere Perform in Those Who Previously Dropped Out of Contact Lenses Due to Comfort or Dryness?
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
May 23, 2022 (Actual)
Primary Completion Date
August 30, 2023 (Actual)
Study Completion Date
August 30, 2023 (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
Data Monitoring Committee
No

5. Study Description

Brief Summary
CL discomfort is a complex phenomenon that has been defined by the Tear Film and Ocular Surface Society in their seminal report on contact lens (CL) discomfort as a condition that results in "episodic or persistent adverse ocular sensation related to lens wear, either with or without visual disturbance resulting from reduced compatibility between the CL and the environment, which can lead to decreased wearing time and discontinuation of CL wear." A recent review by Pucker and Tichenor found that CL discomfort was the top reason for established CL wears to cease wearing CLs. This same review alarmingly found that the frequency of CL dropout was about 20% across the many studies aimed at evaluating this condition, which is surprising given the introduction of better soft CL materials and daily disposable CLs over the past 20 plus years. Dailies Total1 (DT1), which is a relatively new daily disposable CL, is a commonly used trouble shooting CL for patients who have failed with other CLs because DT1 utilizes advanced material technology that is specifically aimed at improving CL comfort. While DT1 is commonly used in these struggling patients, the literature currently lacks a targeted study aimed at understanding the frequency of successfully refitting CL dropouts into this advanced CL. Thus, the purpose of this study is to determine the frequency that past CL wearers who failed because of dryness or CL discomfort who can comfortable wear DT1.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Eye, Contact Lens Complication
Keywords
Contact Lens, Dailies Total1, Dry Eye, Comfort

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
All participants will be assigned to wear Dailies Total 1 Sphere contact lenses. They will report to 3 in person visits over the course of one month.
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dailies Total1
Arm Type
Experimental
Arm Description
All participants will be asked to wear Dailies Total1 for the duration of this study.
Intervention Type
Device
Intervention Name(s)
DT1 Sphere Contact Lenses
Intervention Description
Devices: Dailies Total 1 Sphere Contact Lenses
Primary Outcome Measure Information:
Title
Visual Analog Scale (VAS) Contact Lenses Comfort Scores
Description
The frequency of participants who have comfortable (positive) visual analog scale (VAS) scores at both the 1-month (-50 to +50 scale with scores greater than 0 being comfortable).
Time Frame
1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Adults 18-40 Past contact lens wearers who have best corrected 20/20 visual acuity or better Participants will have had to have worn contact lenses for at least 1 year in the past Dropped out of contact lenses in the past 2 years do to discomfort or dryness Scores of 3 or less on the SPEED questionnaire Be able to be refit into Dailies Total1 Sphere contact lenses Provide a glasses prescription that is less than 3-years-old Exclusion Criteria: Past rigid contact lens wearers A past history of being diagnosed with dry eye or ocular allergies Known systemic health conditions that are known to alter tear film physiology History of viral eye disease History of ocular surgery History of severe ocular trauma History of corneal dystrophies or degeneration Having active ocular infection or inflammation Currently using isotretinoin-derivatives or ocular medication Pregnant or breast feeding
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35213
Country
United States
Facility Name
Kannarr Eye Care
City
Pittsburg
State/Province
Kansas
ZIP/Postal Code
66762
Country
United States
Facility Name
ProCare Vision Center
City
Granville
State/Province
Ohio
ZIP/Postal Code
43023
Country
United States
Facility Name
The Southern College of Optometry
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38104
Country
United States

12. IPD Sharing Statement

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Dailies Total 1 Sphere Contact Lenses

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