To Evaluate the Performance of Total 30 (Lehifilcon A) Contact Lenses in Patients Using Digital D… (NCT06317038) | Clinical Trial Compass
CompletedNot Applicable
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.
United States35 participantsStarted 2024-03-31
Plain-language 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.
Who can participate
Age range18 Years – 40 Years
SexALL
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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 …
What they're measuring
1
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).