CompletedNot Applicable

Total30 for Astigmatism Contact Lenses

United States48 participantsStarted 2023-10-15

Plain-language summary

Determine if Total30 for Astigmatism contact lenses (CLs) provide a comfortable wearing experience all day. CL discomfort affects most CL wearers with discomfort consistently topping the reasons why established CL wearers drop out of CLs. In fact, studies have consistently found that the frequency of CL dropout is around 20% with this dropout frequency staying relatively stable over the past 20 plus years. This static frequency of CL dropout is surprising since there have been a number of dramatic soft CL innovations during this time frame (e.g., widely available daily disposable CLs, silicone hydrogel CL materials with high oxygen transmissibility, new CL surface coatings).

Who can participate

Age range18 Years – 45 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: * 18- to 45-year-old * Visual acuity 20/20 or better * Contact Lens Dry Eye Questionnaire \[CLDEQ\]-8 scores \<10 * Willing to wear Total30 for Astigmatism CLs * Have a smart phone with text messaging capabilities * Astigmatism ranging from 0.75 D to 2.50 D in each eye * Regularly worn 2 week or monthly CLs within the past 6 months * Current CL wearer * Glasses prescription that is less than 2 years old * Willing to start wearing their CLs between 6:00 AM and 8:00 AM and wear their CLs until 11:00 PM each day text messaging data is collected Exclusion Criteria: * Current or past hard CL wearers * A known systemic health condition that is thought to alter tear film physiology * A history of viral eye disease * A history of ocular surgery * A history of severe ocular trauma * Have an active ocular infection or inflammation * Currently using isotretinoin-derivatives or ocular medications * Currently using rewetting drops or artificial tears * Pregnant or breast feeding * Willing to discontinue usage of current toric CLs one week prior to the initial visit

What they're measuring

Visual Analog Scale (VAS) Comfort Scores

Timeframe: Change from baseline at 1 month

Trial details

NCT IDNCT06052046

SponsorSouthern College of Optometry

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-05-11