CompletedNot Applicable

Clinical Evaluation of Biomedics Monthly Sphere and Avaira Vitality Sphere

Mexico44 participantsStarted 2024-04-03

Plain-language summary

The aim of this study is to compare the short-term clinical performance of two sphere contact lenses.

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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 the required time of the study.
✓. Is willing and able to follow instructions and maintain the appointment schedule.
✓. Has refractive astigmatism no higher than -0.75 DC.
✓. Can be fit with the available lens parameters (sphere +6.00 to -10.00D).
✓. Can achieve binocular distance vision of at least 20/30 Snellen (logMAR 0.18) with the study contact lenses.

✕. 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.

Lens Fit Acceptance Ratings

Timeframe: At the end of 15 Minutes of wear

NCT IDNCT06400914

SponsorCooperVision, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-05-11

Results submitted2025-05-27

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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 the required time of the study.
✓. Is willing and able to follow instructions and maintain the appointment schedule.
✓. Has refractive astigmatism no higher than -0.75 DC.
✓. Can be fit with the available lens parameters (sphere +6.00 to -10.00D).
✓. Can achieve binocular distance vision of at least 20/30 Snellen (logMAR 0.18) with the study contact lenses.

✕. 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.