Clinical trial NCT06052046: Total30 for Astigmatism Contact Lenses
Official title: How Does Total30 for Astigmatism Perform During a Long Day of Wear?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Contact Lens Complication
Astigmatism
Refractive Errors
Keywords: TOTAL30 for Astigmatism
Comfort
Dryness
Visual Analog Scale
Contact Lens
Lead sponsor: Southern College of Optometry
Sponsor class: OTHER
Collaborators: name: Alcon Research
First posted: 2023-09-25
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This prospective, one-month, three-visit study will refit all participants into TOTAL30 for Astigmatism Contact Lenses.
Primary purpose: TREATMENT

Brief summary: Determine if Total30 for Astigmatism contact lenses (CLs) provide a comfortable wearing experience all day. CL discomfort affects most CL wearers with discomfort consistently topping the reasons why established CL wearers drop out of CLs. In fact, studies have consistently found that the frequency of CL dropout is around 20% with this dropout frequency staying relatively stable over the past 20 plus years. This static frequency of CL dropout is surprising since there have been a number of dramatic soft CL innovations during this time frame (e.g., widely available daily disposable CLs, silicone hydrogel CL materials with high oxygen transmissibility, new CL surface coatings).

Detailed description: A common issues that contact lens (CL) wearers frequently face is that their discomfort symptoms increase towards the end of the wear day. This burdensome discomfort can unfortunately cause patients to remove their CLs before their desired wear time. While comfortable wear times vary from patient to patient, Terry et al. has suggested that patients should be able to comfortably wear their CLs for at least 12 hours per day for at least 6 days per week. Nevertheless, the literature currently lacks sufficient data to comment fully on the full day wear experience, which for many patients may be 16 or more hours per day, especially if they have demanding careers. One CL that has the potential to allow for all day comfort is the Total30 for Astigmatism CLs, which is a new water gradient, monthly CL aimed at delivering all day comfort and visual performance. Thus, the purpose of this study is to map comfort over the full wear day in established, asymptomatic, soft CL wearers who are refit in Total30 for Astigmatism CLs. These data are not only important for judging the performance of Total30 for Astigmatism CLs, but they will provide some of the first insights into the full day CL wearing experience over one month.

Eligibility criteria: Inclusion Criteria:

* 18- to 45-year-old
* Visual acuity 20/20 or better
* Contact Lens Dry Eye Questionnaire \[CLDEQ\]-8 scores \<10
* Willing to wear Total30 for Astigmatism CLs
* Have a smart phone with text messaging capabilities
* Astigmatism ranging from 0.75 D to 2.50 D in each eye
* Regularly worn 2 week or monthly CLs within the past 6 months
* Current CL wearer
* Glasses prescription that is less than 2 years old
* Willing to start wearing their CLs between 6:00 AM and 8:00 AM and wear their CLs until 11:00 PM each day text messaging data is collected

Exclusion Criteria:

* Current or past hard CL wearers
* A known systemic health condition that is thought to alter tear film physiology
* A history of viral eye disease
* A history of ocular surgery
* A history of severe ocular trauma
* Have an active ocular infection or inflammation
* Currently using isotretinoin-derivatives or ocular medications
* Currently using rewetting drops or artificial tears
* Pregnant or breast feeding
* Willing to discontinue usage of current toric CLs one week prior to the initial visit

Primary outcomes:
measure: Visual Analog Scale (VAS) Comfort Scores
timeFrame: Change from baseline at 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Pittsburg
country: United States
facility: Kannarr Eye Care
state: Kansas
city: Coldwater
country: United States
facility: Coldwater VIsion Center
state: Mississippi
Study officials:
References: