Eye Strain
Conditions
Keywords
Contact lenses, Digital Devices, Eye Comfort
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.
Interventions
DEVICETotal 30 Contact Lens
Patients will be give a contact lens for 1 month
Sponsors
Alcon Research
Tauber Eye Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Intervention model description
Open label Observation
Eligibility
Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
Countries
United States
Outcome results
None listed