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Completed
NCT05656885
Clinical Evaluation of Two Frequent Replacement Soft Spherical Contact Lenses
Conditions: Myopia, Hyperopia
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: 1
Phase: NA
Enrollment: 40
Sponsor: Coopervision, Inc.
Location: Spain
Summary
The study objective was to compare short-term clinical performance data of two soft spherical contact lenses.
Eligibility Criteria
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.
Source: ClinicalTrials.gov (NCT05656885). StuddyBuddy aggregates publicly available trial information.
