Dailies Total 1 Sphere Contact Lenses

NCT05239494 | Completed Results FDA Device

• 1 other identifier: IRB-300008359
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 4

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.

Conditions

Dry Eye; Contact Lens Complication

Keywords

Contact Lens; Dailies Total1; Dry Eye; Comfort

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Likert Questionnaire

  One Month

Study Arms (1)

Dailies Total1

EXPERIMENTAL

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

Device: DT1 Sphere Contact Lenses

Interventions

DT1 Sphere Contact Lenses DEVICE

Devices: Dailies Total 1 Sphere Contact Lenses

Dailies Total1

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Alabama at Birmingham: lead
• Alcon Research: collaborator

Study Sites (4)

University of Alabama at Birmingham

Birmingham, Alabama, 35213, United States

Location

Kannarr Eye Care

Pittsburg, Kansas, 66762, United States

Location

ProCare Vision Center

Granville, Ohio, 43023, United States

Location

The Southern College of Optometry

Memphis, Tennessee, 38104, United States

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Results Point of Contact

• Title: Andrew Pucker, OD, PhD
• Organization: University of Alabama at Birmingham

andrewpucker@hotmail.com

920-579-2900

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 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.

Study Record Dates

• First Submitted: February 4, 2022
• First Posted: February 15, 2022
• Study Start: May 23, 2022
• Primary Completion: August 30, 2023
• Study Completion: August 30, 2023
• Last Updated: October 1, 2024
• Results First Posted: September 19, 2024

Record last verified: 2024-09

Locations

US (4)