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.
Not Applicable
Completed
- Conditions
- Eye Strain
- Interventions
- Device: Total 30 Contact Lens
- Registration Number
- NCT06317038
- Lead Sponsor
- Tauber Eye Center
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 35
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Digital Device uses for 8 hours per day Total 30 Contact Lens Observational responses from patients using digital devices for 8 hours per day will be given a monthly Total 30 Contact lens.
- Primary Outcome Measures
Name Time Method 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). 1 month Likert Questionaire: Strongly Disagree, Disagree, Neither Agree nor Disagree, Agree, Strongly Agree
- Secondary Outcome Measures
Name Time Method Results of subjective ratings of patients using Total 30 lenses and heavy digital device usage with VAS diary questionnaire. 1 month VAS diary: scale 0-100 (0=No Discomfort 100= Maximal Comfort)
Report on total daily wear time and digital device usage. 1 month Survey: Total number of hours
Likert responses to insertion comfort and overall vision, and heavy digital device use on a typical day after 1 month of wear. 1 month Likert Questionaire: Strongly Disagree, Disagree, Neither Agree nor Disagree, Agree, Strongly Agree
Trial Locations
- Locations (1)
Tauber Eye Center
🇺🇸Kansas City, Missouri, United States