A Clinical Comparison of Marketed Lens Care Solutions With Avaira Lens Brand

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

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-08-31

Study Completion Date

2010-09-30

Brief Summary

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This study is a clinical comparison of the biocompatibility of several multipurpose solutions, Renu Fresh, Optifree Replenish, and ClearCare, and saline as a control solution among adapted hydrogel contact lens wearers wearing Avaira (enfilcon A) contact lenses at one research site.

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Detailed Description

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Conditions

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Corneal Staining

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Multipurpose Solution #1

B\&L Renu Fresh Multipurpose Solution

Group Type EXPERIMENTAL

Multipurpose Solution #1

Intervention Type OTHER

B\&L Renu Fresh Multipurpose Solution

Multipurpose Solution #2

Intervention Type OTHER

Optifree Replenish Multipurpose Solution

Mutlipurpose Solution #3

Intervention Type OTHER

Ciba ClearCare Multipurpose Solution

Multipurpose Solution #4

Intervention Type OTHER

Saline Solution

Multipurpose Solution #2

OptiFree Replenish Multipurpose Solution

Group Type EXPERIMENTAL

Multipurpose Solution #1

Intervention Type OTHER

B\&L Renu Fresh Multipurpose Solution

Multipurpose Solution #2

Intervention Type OTHER

Optifree Replenish Multipurpose Solution

Mutlipurpose Solution #3

Intervention Type OTHER

Ciba ClearCare Multipurpose Solution

Multipurpose Solution #4

Intervention Type OTHER

Saline Solution

Multipurpose Solution #3

Ciba ClearCare Multipurpose Solution

Group Type EXPERIMENTAL

Multipurpose Solution #1

Intervention Type OTHER

B\&L Renu Fresh Multipurpose Solution

Multipurpose Solution #2

Intervention Type OTHER

Optifree Replenish Multipurpose Solution

Mutlipurpose Solution #3

Intervention Type OTHER

Ciba ClearCare Multipurpose Solution

Multipurpose Solution #4

Intervention Type OTHER

Saline Solution

Multipurpose Solution #4

Saline Solution

Group Type ACTIVE_COMPARATOR

Multipurpose Solution #1

Intervention Type OTHER

B\&L Renu Fresh Multipurpose Solution

Multipurpose Solution #2

Intervention Type OTHER

Optifree Replenish Multipurpose Solution

Mutlipurpose Solution #3

Intervention Type OTHER

Ciba ClearCare Multipurpose Solution

Multipurpose Solution #4

Intervention Type OTHER

Saline Solution

Interventions

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Multipurpose Solution #1

B\&L Renu Fresh Multipurpose Solution

Intervention Type OTHER

Multipurpose Solution #2

Optifree Replenish Multipurpose Solution

Intervention Type OTHER

Mutlipurpose Solution #3

Ciba ClearCare Multipurpose Solution

Intervention Type OTHER

Multipurpose Solution #4

Saline Solution

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Informed Consent and HIPAA document read, signed, and dated.
* Visual acuity correctable to 20/30 (Snellen) or better in each eye at distance with hydrogel or silicone hydrogel contact lenses.
* Successfully wearing hydrogel or silicone hydrogel contact lenses on a daily wear basis for at least two weeks prior to the study.

Exclusion Criteria

* History of hypersensitivity
* Evidence or history of epithelial herpes simplex keratitis (dendritic keratitis; vaccinia, active or recent varicella, viral disease of the cornea and/or conjunctiva and/or eyelids; bacterial infection of the eye; and/or fungal disease of the eye
* One functional eye or a monofit eye
* Ocular conditions such as active acute blepharitis, conjunctival infections, and iritis
* Type 2 (macropunctate) or greater corneal staining in any region in either eye as observed by slit-lamp at Visit 1 of each study period
* Sum of the type of corneal staining greater than or equal to 4 across entire cornea in either eye as observed by slit-lamp at Visit 1 of each study period
* Conjunctival staining covering greater than or equal to 20% in 2 or more corneal regions in either eye as observed by slit-lamp at Visit 1 of each study period
* Conjunctival injection greater than Grade 2 (moderate-diffuse redness) in either eye as observed by slit-lamp at Visit 1 of each study period
* Abnormal lenticular opacity in the visual axis of the lens in either eye
* Use of concomitant topical Rx or over-the-counter (OTC) ocular medications
* History of seasonal allergies with significant ocular side effects which may have an adverse impact on contact lens wear
* Pregnant or lactating females

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes