Clinical Performance of a Monthly Replacement Silicone Hydrogel Lens

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

88 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-08-01

Study Completion Date

2018-09-27

Brief Summary

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The purpose of this study is to assess the clinical performance of an investigational, coated silicone hydrogel contact lens over approximately 30 days of daily wear.

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Detailed Description

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Conditions

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Refractive Errors

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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LID014341

LID014341 contact lenses worn bilaterally (in both eyes) for 30 days on a daily wear basis

Group Type EXPERIMENTAL

LID014341 contact lenses

Intervention Type DEVICE

Investigational monthly replacement silicone hydrogel contact lenses with water gradient coating

Biofinity

Comfilcon A contact lenses worn bilaterally for 30 days on a daily wear basis

Group Type ACTIVE_COMPARATOR

Comfilcon A contact lenses

Intervention Type DEVICE

Silicone hydrogel contact lenses

Interventions

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LID014341 contact lenses

Investigational monthly replacement silicone hydrogel contact lenses with water gradient coating

Intervention Type DEVICE

Comfilcon A contact lenses

Silicone hydrogel contact lenses

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 informed consent form approved by an Institutional review board (IRB);
* Successful wear of spherical monthly replacement soft contact lenses in both eyes for a minimum of 5 days per week and 8 hours per day during the past 3 months;
* Best-corrected visual acuity (BCVA) 20/25 or better in each eye;
* Willing to stop wearing habitual contact lenses for the duration of study participation.

Exclusion Criteria

* Any conditions or use of medications that could contraindicate contact lens wear;
* History of or plan to have refractive surgery in either eye;
* Irregular cornea in either eye;
* Ocular or intraocular surgery (excluding placement of punctal plugs) within the previous 12 months or planned during the study;
* Current or history of intolerance, hypersensitivity or allergy to any component of the study products;
* Wearing habitual contact lenses in an extended wear modality (routinely sleeping in lenses for at least 1 night per week) over the last 3 months prior to enrollment;
* Use of topical ocular medications and artificial tear or rewetting drops requiring instillation during contact lens wear;
* Habitual Biofinity contact lens wearers.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No