Clinical Evaluation of Biomedics Monthly Sphere and Avaira Vitality Sphere

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-04-03

Study Completion Date

2024-05-11

Brief Summary

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

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Detailed Description

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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.

Conditions

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Ametropia

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Lens A (ocufilcon D)

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

Group Type EXPERIMENTAL

Lens A (ocufilcon D)

Intervention Type DEVICE

15 minutes of daily wear.

Lens B (fanfilcon A)

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

Group Type EXPERIMENTAL

Lens B (fanfilcon A)

Intervention Type DEVICE

15 minutes of daily wear.

Interventions

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Lens A (ocufilcon D)

15 minutes of daily wear.

Intervention Type DEVICE

Lens B (fanfilcon A)

15 minutes of daily wear.

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No