Clinical trial NCT06317038: To Evaluate the Performance of Total 30 (Lehifilcon A) Contact Lenses in Patients Using Digital Devices for Greater Than 8 Hours Per Day 5 Days Per Week Based on Subjective Reported Data.
Official title: Performance of TOTAL30 (Lehfilcon A) Contact Lenses in Patients Using Digital Devices and 89814415
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Eye Strain
Keywords: Contact lenses
Digital Devices
Eye Comfort
Lead sponsor: Tauber Eye Center
Sponsor class: OTHER
Collaborators: name: Alcon Research
First posted: 2024-03-19
Enrollment: 35
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: Open label Observation
Primary purpose: OTHER

Brief summary: To evaluate the performance of Total 30® (lehfilcon A) contact lenses in patients using digital devices for greater than 8 hours per day 5 days per week based on subjective reported data.


Eligibility criteria: Inclusion Criteria:

* Adult patients aged 18-40 of any sex and any race.
* Reports habitually using digital device usage (phone, Ipad, computer, social media, video streaming) for 8 hours or more per day 5 days per week with plans to continue the habit throughout the study.
* Wearing contact lenses for at least 13 hours daily 5 days per week.
* Spherical refractive error between -11.00 D and +6.00D with \< -0.75 D of astigmatism.
* Willing to comply with the protocol instructions.
* Has read (or has had read to), understood, and signed an Informed Consent.
* Willing to not use any artificial tears, rewetting drops or dry eye treatments during the study.

Exclusion Criteria:

* Active ocular infection or ocular inflammatory disease.
* Presbyopic or pre-presbyopic that have a measured add power for reading.
* Current Total 30 contact lens wearer.
* Anterior basement membrane dystrophy or history of recurrent erosion syndrome or topographical abnormalities that might indicate ectasia or other corneal degenerative conditions.
* Current or previous diagnosis of dry eye disease; currently using a dry eye treatment including but not limited to artificial tears, rewetting drops or prescription treatments.
* History of severe / serious ocular pathology or other medical conditions that could result in an inability to safely complete the study.
* Participation by the patient in any other investigational study within the past 30 days.
* Unlikely to comply with protocol instructions for any reason (confusion, substance abuse, etc.). The Principal Investigator or the Medical Monitor reserves the right to declare a patient ineligible based on medical evidence that indicates the patient is unsuitable for the study.
* Inability to utilize Clear Care Cleaning solution.
* Pregnancy

Primary outcomes:
measure: Likert question about comfort satisfaction while wearing Total 30 contact lenses on a typical day (> 13 hours of daily wear) after 1 month of wear and heavy digital device usage (>8 hours daily wear).
timeFrame: 1 month
Secondary outcomes:
measure: Likert responses to insertion comfort and overall vision, and heavy digital device use on a typical day after 1 month of wear.
timeFrame: 1 month
measure: Results of subjective ratings of patients using Total 30 lenses and heavy digital device usage with VAS diary questionnaire.
timeFrame: 1 month
measure: Report on total daily wear time and digital device usage.
timeFrame: 1 month
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: Tauber Eye Center
state: Missouri
Study officials:
References: