A Clinical Comparison of Two Soft Contact Lenses

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

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-11-24

Study Completion Date

2022-12-05

Brief Summary

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The study objective was to gather short-term clinical performance data for two soft contact lenses.

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Detailed Description

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The aim of this subject-masked, non-randomized, controlled non-dispensing study was to evaluate the short-term clinical performance of a monthly sphere contact lens when compared to a daily disposable contact lens after 15 minutes of daily wear each.

Conditions

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Myopia Hyperopia

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

All participants received Lens 1 and then Lens 2 in fixed-sequence order.

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Lens 1

All participants wore Lens 1 for 15 minutes (Period 1)

Group Type EXPERIMENTAL

Lens 1 (monthly replacement)

Intervention Type DEVICE

Monthly replacement spherical silicone hydrogel contact lens for 15 minutes

Lens 2

All participants wore Lens 2 for 15 minutes (Period 2)

Group Type EXPERIMENTAL

Lens 2 (daily disposable)

Intervention Type DEVICE

Daily disposable spherical silicone hydrogel contact lens for 15 minutes

Interventions

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Lens 1 (monthly replacement)

Monthly replacement spherical silicone hydrogel contact lens for 15 minutes

Intervention Type DEVICE

Lens 2 (daily disposable)

Daily disposable spherical silicone hydrogel contact lens for 15 minutes

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* They are of legal age (18) and capacity to volunteer.
* They understand their rights as a research subject and are willing and able to sign a Statement of Informed Consent.
* They are willing and able to follow the protocol.
* They currently wear soft contact lenses, or have done so within the past two years.
* They are expected to be able to be fitted with the study lenses within the power range available.

Exclusion Criteria

* They have an ocular disorder which would normally contra-indicate contact lens wear.
* They have a systemic disorder which would normally contra-indicate contact lens wear.
* They are using any topical medication such as eye drops or ointment.
* They are aphakic.
* They have had corneal refractive surgery.
* They have any corneal distortion resulting from previous hard or rigid lens wear or have keratoconus.
* They are pregnant or lactating.
* They have an eye or health condition including an immunosuppressive or infectious disease which would, in the opinion of the investigator, contraindicate contact lens wear or pose a risk to study personnel; or a history of anaphylaxis or severe allergic reaction.
* They have taken part in any contact lens or care system clinical research within two weeks prior to starting this study.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No