Clinical Performance of a Silicone Hydrogel Contact Lens Following Six Nights of Extended Wear

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-08-23

Study Completion Date

2018-09-11

Brief Summary

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The purpose of this clinical study is to evaluate the on-eye performance of an investigational soft contact lens compared to a commercially available soft contact lens following 1 week of extended wear.

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Detailed Description

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Subjects will be randomized to wear the investigational contact lens in 1 eye and the commercially available contact lens in the other eye. Subjects will be expected to attend 3 scheduled study visits: Day 1 Baseline/Dispense; Day 2 Follow-up; and Week 1 Follow-up/Exit. The expected duration of exposure to each of the study lenses for all randomized, completed subjects was approximately 7 days / 6 nights of wear.

Conditions

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Refractive Errors

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

In this contralateral study, subjects will be randomized to wear the investigational lens in 1 eye and the control lens in the other eye.

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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LID011121 (OD) / Biofinity (OS)

LID011121 contact lens worn in the right eye, with comfilcon A contact lens worn in the left eye, as randomized, for approximately 6 nights of extended (overnight) wear

Group Type OTHER

LID011121 contact lens

Intervention Type DEVICE

Investigational silicone hydrogel contact lens

Comfilcon A contact lens

Intervention Type DEVICE

Commercially available silicone hydrogel contact lens

Biofinity (OD) / LID011121 (OS)

Comfilcon A contact lens worn in the right eye, with LID011121 contact lens worn in the left eye, as randomized, for approximately 6 nights of extended (overnight) wear

Group Type OTHER

LID011121 contact lens

Intervention Type DEVICE

Investigational silicone hydrogel contact lens

Comfilcon A contact lens

Intervention Type DEVICE

Commercially available silicone hydrogel contact lens

Interventions

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LID011121 contact lens

Investigational silicone hydrogel contact lens

Intervention Type DEVICE

Comfilcon A contact lens

Commercially available silicone hydrogel contact lens

Intervention Type DEVICE

Other Intervention Names

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Biofinity

Eligibility Criteria

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Inclusion Criteria

* Able to understand and sign an Institutional Review Board/Ethics Committee-approved Informed Consent form.
* Successful wear of spherical soft contact lenses in both eyes during the past 3 months for a minimum of 5 days per week and in an extended wear modality a minimum of 1 night per week.
* Best Corrected Visual Acuity (BCVA) of 20/25 or better in each eye.

Exclusion Criteria

* Any condition, use of medications, or surgery that could contraindicate contact lens wear, as determined by the Investigator.
* Current Biofinity© lens wearer.
* Pregnant or breast-feeding.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No