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OpenTrials
Completed

NCT Number: NCT05239494

Dailies Total 1 Sphere Contact Lenses

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.

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Key information

Conditions

Dry Eye Contact Lens Complication Dry Eye Syndromes Eye Diseases Lacrimal Apparatus Diseases

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Alabama at Birmingham, Birmingham, Alabama, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

DT1 Sphere Contact Lenses

Device

Devices: Dailies Total 1 Sphere Contact Lenses

Primary outcomes

  1. Visual Analog Scale (VAS) Contact Lenses Comfort Scores

    Time frame: 1 month

    The median visual analog scale (VAS) scores at the 1-month visit (-50 to +50 scale with scores greater than 0 being comfortable).

Secondary outcomes

  1. Likert Questionnaire

    Time frame: One Month

    Number of participants who were likely to refer the study contact lens to a friend.

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Collaborators

  • Alcon Research

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Feb 15, 2022
Registry last updated
Oct 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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