Dailies Total 1 Sphere Contact Lenses

Dry Eye Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05239494
• Other study ID #: IRB-300008359
• Status: Completed
• Phase: N/A
• Start date: May 23, 2022
• Est. completion date: August 30, 2023

Study information

• Verified date: September 2023
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: August 30, 2023
• Est. primary completion date: August 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Contact Lens Complication
• Dry Eye
• Dry Eye Syndromes

Intervention

Device:
• DT1 Sphere Contact Lenses
Devices: Dailies Total 1 Sphere Contact Lenses

Locations

Country	Name	City	State
United States	University of Alabama at Birmingham	Birmingham	Alabama
United States	ProCare Vision Center	Granville	Ohio
United States	The Southern College of Optometry	Memphis	Tennessee
United States	Kannarr Eye Care	Pittsburg	Kansas

Sponsors (2)

Lead Sponsor	Collaborator
University of Alabama at Birmingham	Alcon Research

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	1 month