Clinical Evaluation of Biomedics Monthly Sphere and Avaira Vitality Sphere

CooperVision International Limited (CVIL)

Status: Completed

Conditions: Ametropia

Treatments: Device: Lens A (ocufilcon D); Device: Lens B (fanfilcon A)

Study type: Interventional

Funder types: Industry

Identifiers

NCT06400914

EX-MKTG-156

Details and patient eligibility

About

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

Full description

The aim of this study is to evaluate the short-term clinical performance of two different sphere contact lenses after 15 minutes of daily wear each.

Enrollment: 40 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Is at least 18 years of age and has full legal capacity to volunteer.
2. Has read and signed an information consent letter.
3. Self-reports having a full eye examination in the previous two years.
4. Anticipates being able to wear the study lenses for the required time of the study.
5. Is willing and able to follow instructions and maintain the appointment schedule.
6. Has refractive astigmatism no higher than -0.75 DC.
7. Can be fit with the available lens parameters (sphere +6.00 to -10.00D).
8. Can achieve binocular distance vision of at least 20/30 Snellen (logMAR 0.18) with the study contact lenses.

Exclusion criteria

1. Is participating in any concurrent clinical or research study.
2. Has any known active ocular disease and/or infection that contraindicates contact lens wear.
3. Has a systemic condition that in the opinion of the investigator may affect a study outcome variable.
4. Is using any systemic or topical medications that in the opinion of the investigator may affect contact lens wear or a study outcome variable.
5. Has known sensitivity to the diagnostic sodium fluorescein used in the study.
6. Self-reports as pregnant, lactating or planning a pregnancy at the time of enrolment.
7. Has undergone refractive error surgery or intraocular surgery.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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40 participants in 2 patient groups

Lens A (ocufilcon D)

Experimental group

Description:

All participants will wear lens A for 15 minutes (Period 1).

Treatment:

Device: Lens A (ocufilcon D)

Lens B (fanfilcon A)

Experimental group

Description:

All participants will wear lens B for 15 minutes (Period 2).

Treatment:

Device: Lens B (fanfilcon A)