Dailies Total 1 Sphere Contact Lenses

How Does DT1 Sphere Perform in Those Who Previously Dropped Out of Contact Lenses Due to Comfort or Dryness?

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.

Study Overview

• Status: Completed
• Conditions: Dry Eye; Contact Lens Complication
• Intervention / Treatment: Device: DT1 Sphere Contact Lenses

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35213
      • University of Alabama at Birmingham
  • Kansas
    • Pittsburg, Kansas, United States, 66762
      • Kannarr Eye Care
  • Ohio
    • Granville, Ohio, United States, 43023
      • ProCare Vision Center
  • Tennessee
    • Memphis, Tennessee, United States, 38104
      • The Southern College of Optometry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• 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: Dailies Total1; All participants will be asked to wear Dailies Total1 for the duration of this study.	Device: DT1 Sphere Contact Lenses; Devices: Dailies Total 1 Sphere Contact Lenses

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Analog Scale (VAS) Contact Lenses Comfort Scores	The median visual analog scale (VAS) scores at the 1-month visit (-50 to +50 scale with scores greater than 0 being comfortable).	1 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Likert Questionnaire	Number of participants who were likely to refer the study contact lens to a friend.	One Month

Collaborators and Investigators

• Sponsor: University of Alabama at Birmingham
• Collaborators: Alcon Research

Study record dates

Study Major Dates

• Study Start (Actual): May 23, 2022
• Primary Completion (Actual): August 30, 2023
• Study Completion (Actual): August 30, 2023

Study Registration Dates

• First Submitted: February 4, 2022
• First Submitted That Met QC Criteria: February 12, 2022
• First Posted (Actual): February 15, 2022

Study Record Updates

• Last Update Posted (Actual): October 1, 2024
• Last Update Submitted That Met QC Criteria: September 10, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Keywords: Dry Eye; Comfort; Contact Lens; Dailies Total1
• Additional Relevant MeSH Terms: Eye Diseases; Lacrimal Apparatus Diseases; Dry Eye Syndromes
• Other Study ID Numbers: IRB-300008359

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