Total30 For Contact Lens Dropouts (NCT06967298) | Clinical Trial Compass
CompletedNot Applicable
Total30 For Contact Lens Dropouts
United States60 participantsStarted 2024-04-23
Plain-language summary
Contact lens (CL) discomfort is a complex phenomenon that has been defined by the Tear Film and Ocular Surface Society (TFOS) in their seminal report on CL discomfort as a condition that results in "episodic or persistent adverse ocular sensation related to lens wear, either with or without visual disturbance resulting from reduced compatibility between the CL and the environment, which can lead to decreased wearing time and discontinuation of CL wear."
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:
* Adults, 18- to 40-year-old, past CL wearers who have best corrected 20/20 visual acuity or better
* Participants will be required to have worn reusable CLs for at least one year in the past.
* Participants over the age of 40 years will be excluded to avoid presbyopia-related vision issues.
* Participants must have dropped out of reusable CLs within the past two years because of discomfort or dryness.
This determination will be made by listing Young et al.'s list of reasons for dropping out of CLs and asking the participants to indicate their top reason for dropping out of CLs:
a. Discomfort or Dryness b. General Poor Vision, c. Poor Reading Vision, d. Difficulty with Handling, e. Advised by Practitioner, f. Inconvenient, g. Eyes were Red, h. Lost Interest, i. Too Costly, j. Reaction to Care Products, k. Lost Lenses, l. Other.
* . Participants will be considered a CL dropout if they have not worn CLs in the past 3 months. Participants will be required to have scores of ≤3 on the SPEED questionaries' (no significant dry eye symptoms).
* Participants will be required to be able to wear T30 sphere CLs (astigmatism ≤ 0.75 D OD/OS).
* Participants will be required to provide a prescription for glasses that is less than 3 years old.
Exclusion Criteria:
* if they are past rigid CL wearers,
* have worn reusable CLs within the past two years,
* have a history of being diagnosed with dry eye or ocular allergies,
* have known systemic health conditions that ar…
What they're measuring
1
Likelihood of continuing to wear T30 CLs at 1 month and 6 months
Timeframe: 1 month and 6 months
2
Overall satisfaction while wearing T30 CLs at 1 month and 6 months.