Clinical Evaluation of Two Frequent Replacement Soft Spherical Contact Lenses (NCT05656885) | Clinical Trial Compass
CompletedNot Applicable
Clinical Evaluation of Two Frequent Replacement Soft Spherical Contact Lenses
Spain40 participantsStarted 2022-09-27
Plain-language summary
This was a single-blind (participant masked), interventional, prospective, direct refit, bilateral wear short-term fitting study.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Is at least 18 years of age and has full legal capacity to volunteer.
* Has read and signed an information consent letter.
* Self-reports having a full eye examination in the previous two years.
* Anticipates being able to wear the study lenses for at least 8 hours a day, 5 days a week.
* Is willing and able to follow instructions and maintain the appointment schedule.
* Habitual soft contact lens wearers who currently wear sphere contact lenses, or use spectacles for all distances vision correction, for the past 3 months minimum.
* Has refractive astigmatism no higher than -0.75DC.
* Can be fit and achieve binocular distance vision of at least 20/30 Snellen (or +0.20 logMAR) which participants also deem to be 'acceptable', with the available study lens parameters (powers +8.00 to -12.00DS)
Exclusion Criteria:
* Is participating in any concurrent clinical or research study.
* Has any known active ocular disease and/or infection that contraindicates contact lens wear.
* Has a systemic condition that in the opinion of the investigator may affect a study outcome variable.
* Is using any systemic or topical medications that in the opinion of the investigator may affect contact lens wear or a study outcome variable.
* Has known sensitivity to the diagnostic sodium fluorescein used in the study.
* Self-reports as pregnant, lactating or planning a pregnancy at the time of enrolment.
* Has undergone refractive error surgery or intraocular surgery.