T30 for Astigmatism in Digital Device Users (NCT06266728) | Clinical Trial Compass
CompletedNot Applicable
T30 for Astigmatism in Digital Device Users
United States48 participantsStarted 2024-03-15
Plain-language summary
This study aims to determine if Total30 lenses for astigmatism can be successfully fit in participants who are heavy digital device users.
Who can participate
Age range18 Years – 40 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Adult (18- to 40-year-old)
* 0.00 LogMAR visual acuity or better in their habitual CLs or by manifest refraction in both eyes
* Smart phone with text messaging capabilities
* Existing wearers of soft, frequent replacement toric CLs within past 6 months
* Frequent digital device user (e.g., phone, iPad, computer, social media, video streaming, etc.) defined as at least 8 hours of usage per day
* Willing to follow the required wear schedule
* Astigmatism ranging from 0.75 D to 2.50 D in each eye
* Willing to wear their CLs at least 13 hours/day
Exclusion Criteria: Have known systemic health conditions that are thought to alter tear film physiology (e.g., Sjögren's syndrome).
* Have a known history of being diagnosed with dry eye disease
* Have a history of ocular surgery within the past 12 months
* Have a history of severe ocular trauma, active ocular infection or inflammation
* Have a history of viral eye disease
* Currently using isotretinoin-derivatives or ocular medications
* Currently using a dry eye treatment including but not limited to artificial tears
* Currently using rewetting drops daily or occasionally
* If they are pregnant or breast feeding
* Need for spectacle add power of any amount (presbyopic)
* Currently wearing T30fA CLs
* Have a history of wearing hard CLs
* Subjects who show excessive lens oscillation with the T30fA lenses during the fitting process yet show 0.0 logMAR acuity, will be excluded from the study.
* Patients who report…
What they're measuring
1
Visual Analog Scale (VAS) Comfort Scores
Timeframe: Baseline to 1 month of Contact lens wear