Clinical trial NCT06967298: Total30 For Contact Lens Dropouts
Official title: How Does Total 30 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
Contact Lenses
Lead sponsor: Southern College of Optometry
Sponsor class: OTHER
Collaborators: name: Alcon Research
First posted: 2025-05-13
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: This prospective 6 month 4 visit survey will refit individuals who have previously dropped out of contact lenses that is stopped wearing them due to discomfort into T30 contact lenses to determine if they are comfortable.
Primary purpose: TREATMENT

Brief summary: Contact lens (CL) discomfort is a complex phenomenon that has been defined by the Tear Film and Ocular Surface Society (TFOS) in their seminal report on 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."

Detailed description: Contact lens (CL) discomfort is a complex phenomenon that has been defined by the Tear Film and Ocular Surface Society (TFOS) in their seminal report on 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."1 While CL dropout occurs in about 20% of wearers annually the majority of CL wearers who cease wearing their CLs have a desire to continue wearing their CL if given the opportunity.3 A recent review by Pucker and Tichenor found that CL discomfort was the top reason for established CL wears to cease wearing CLs Therefore, providing CL dropouts with an alternative material, which may be more comfortable than their past CLs, could be a means for curbing CL dropout.

Our recent work found that when 60 participants who had previously dropped out of CLs were given the opportunity to be refit into Dailies TOTAL1® CLs that 100% of them were still wearing Dailies TOTAL1® at 1 month and 98% of them were still wearing their CLs at 6 months. When these participants were asked at the 1-month visit, 98.3%, 86.5%, and 93.2% of them responded that they were very satisfied or satisfied with their vision, their end-of-day CL comfort, and overall CL comfort, respectively. These same participants responded at 6 months that they were very likely or likely to continue to wear the study CLs (80.7%) and to recommend the study CLs to a friend (93.2%). While these data suggest that CL dropout can thrive when being refit into a daily disposable CLs, the literature currently lacks a targeted study aimed at understanding how CL dropouts will respond to being refit into a monthly replacement CL. One good potential monthly CL option is the TOTAL30® (T30) CL. T30 is a relatively new frequent replacement CL, with a biocompatible design. Thus, the purpose of this study is to determine the frequency that CL dropouts who dropped out of CLs because of dryness or discomfort can be comfortably refit into T30 CLs at 1 month.

Eligibility criteria: Inclusion Criteria:

* Adults, 18- to 40-year-old, past CL wearers who have best corrected 20/20 visual acuity or better
* Participants will be required to have worn reusable CLs for at least one year in the past.
* Participants over the age of 40 years will be excluded to avoid presbyopia-related vision issues.
* Participants must have dropped out of reusable CLs within the past two years because of discomfort or dryness.

This determination will be made by listing Young et al.'s list of reasons for dropping out of CLs and asking the participants to indicate their top reason for dropping out of CLs:

a. Discomfort or Dryness b. General Poor Vision, c. Poor Reading Vision, d. Difficulty with Handling, e. Advised by Practitioner, f. Inconvenient, g. Eyes were Red, h. Lost Interest, i. Too Costly, j. Reaction to Care Products, k. Lost Lenses, l. Other.

* . Participants will be considered a CL dropout if they have not worn CLs in the past 3 months. Participants will be required to have scores of ≤3 on the SPEED questionaries' (no significant dry eye symptoms).
* Participants will be required to be able to wear T30 sphere CLs (astigmatism ≤ 0.75 D OD/OS).
* Participants will be required to provide a prescription for glasses that is less than 3 years old.

Exclusion Criteria:

* if they are past rigid CL wearers,
* have worn reusable CLs within the past two years,
* have a history of being diagnosed with dry eye or ocular allergies,
* have known systemic health conditions that are thought to alter tear film physiology,
* have a history of viral eye disease,
* have a history of ocular surgery,
* have a history of severe ocular trauma,
* have a history of corneal dystrophies or degenerations,
* have active ocular infection or inflammation,
* are currently using isotretinoin-derivatives or ocular medications, or
* if they are pregnant or breast feeding.

Primary outcomes:
measure: Likelihood of continuing to wear T30 CLs at 1 month and 6 months
timeFrame: 1 month and 6 months
measure: Overall satisfaction while wearing T30 CLs at 1 month and 6 months.
timeFrame: 1-6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Memphis
country: United States
facility: The Southern College of Optometry
state: Tennessee
Study officials:
References: