Clinical trial NCT05239494: 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
Overall status: COMPLETED
Phase: NA
Conditions: Dry Eye
Contact Lens Complication
Keywords: Contact Lens
Dailies Total1
Dry Eye
Comfort
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
Collaborators: name: Alcon Research
First posted: 2022-02-15
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention 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.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


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

Primary outcomes:
measure: Visual Analog Scale (VAS) Contact Lenses Comfort Scores
timeFrame: 1 month
Secondary outcomes:
measure: Likert Questionnaire
timeFrame: One Month
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Pittsburg
country: United States
facility: Kannarr Eye Care
state: Kansas
city: Granville
country: United States
facility: ProCare Vision Center
state: Ohio
city: Memphis
country: United States
facility: The Southern College of Optometry
state: Tennessee
Study officials:
References: