Evaluation of Silicone Hydrogel Lens Wettability With Marketed Lens Care Solutions

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

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-11-30

Study Completion Date

2011-02-28

Brief Summary

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The purpose of this study is to assess ex vivo wettability of a commonly prescribed silicone hydrogel (SiH) contact lens with three marketed contact lens care solutions.

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Detailed Description

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Conditions

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Contact Lens Wear

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Synergi, then Biotrue, then OTE

Three lens care systems randomly assigned. Contact lenses were pre-soaked overnight prior to insertion, then worn for 8 hours, with a minimum two-day washout between each wear period.

Group Type OTHER

Biotrue multipurpose solution

Intervention Type DEVICE

Contact lens care solution

Sauflon Synergi multipurpose solution

Intervention Type DEVICE

Contact lens care solution

OTE Elements multipurpose solution

Intervention Type DEVICE

Contact lens care solution

Silicone hydrogel contact lenses (Acuvue Advance)

Intervention Type DEVICE

Commercially marketed contact lenses

Synergi, then OTE, then Biotrue

Three lens care systems randomly assigned. Contact lenses were pre-soaked overnight prior to insertion, then worn for 8 hours, with a minimum two-day washout between each wear period.

Group Type OTHER

Biotrue multipurpose solution

Intervention Type DEVICE

Contact lens care solution

Sauflon Synergi multipurpose solution

Intervention Type DEVICE

Contact lens care solution

OTE Elements multipurpose solution

Intervention Type DEVICE

Contact lens care solution

Silicone hydrogel contact lenses (Acuvue Advance)

Intervention Type DEVICE

Commercially marketed contact lenses

Biotrue, then OTE, then Synergi

Three lens care systems randomly assigned. Contact lenses were pre-soaked overnight prior to insertion, then worn for 8 hours, with a minimum two-day washout between each wear period.

Group Type OTHER

Biotrue multipurpose solution

Intervention Type DEVICE

Contact lens care solution

Sauflon Synergi multipurpose solution

Intervention Type DEVICE

Contact lens care solution

OTE Elements multipurpose solution

Intervention Type DEVICE

Contact lens care solution

Silicone hydrogel contact lenses (Acuvue Advance)

Intervention Type DEVICE

Commercially marketed contact lenses

Biotrue, then Synergi, then OTE

Three lens care systems randomly assigned. Contact lenses were pre-soaked overnight prior to insertion, then worn for 8 hours, with a minimum two-day washout between each wear period.

Group Type OTHER

Biotrue multipurpose solution

Intervention Type DEVICE

Contact lens care solution

Sauflon Synergi multipurpose solution

Intervention Type DEVICE

Contact lens care solution

OTE Elements multipurpose solution

Intervention Type DEVICE

Contact lens care solution

Silicone hydrogel contact lenses (Acuvue Advance)

Intervention Type DEVICE

Commercially marketed contact lenses

OTE, then Biotrue, then Synergi

Three lens care systems randomly assigned. Contact lenses were pre-soaked overnight prior to insertion, then worn for 8 hours, with a minimum two-day washout between each wear period.

Group Type OTHER

Biotrue multipurpose solution

Intervention Type DEVICE

Contact lens care solution

Sauflon Synergi multipurpose solution

Intervention Type DEVICE

Contact lens care solution

OTE Elements multipurpose solution

Intervention Type DEVICE

Contact lens care solution

Silicone hydrogel contact lenses (Acuvue Advance)

Intervention Type DEVICE

Commercially marketed contact lenses

OTE, then Synergi, then Biotrue

Three lens care systems randomly assigned. Contact lenses were pre-soaked overnight prior to insertion, then worn for 8 hours, with a minimum two-day washout between each wear period.

Group Type OTHER

Biotrue multipurpose solution

Intervention Type DEVICE

Contact lens care solution

Sauflon Synergi multipurpose solution

Intervention Type DEVICE

Contact lens care solution

OTE Elements multipurpose solution

Intervention Type DEVICE

Contact lens care solution

Silicone hydrogel contact lenses (Acuvue Advance)

Intervention Type DEVICE

Commercially marketed contact lenses

Interventions

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Biotrue multipurpose solution

Contact lens care solution

Intervention Type DEVICE

Sauflon Synergi multipurpose solution

Contact lens care solution

Intervention Type DEVICE

OTE Elements multipurpose solution

Contact lens care solution

Intervention Type DEVICE

Silicone hydrogel contact lenses (Acuvue Advance)

Commercially marketed contact lenses

Intervention Type DEVICE

Other Intervention Names

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Acuvue® Advance™

Eligibility Criteria

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Inclusion Criteria

* 18 years of age
* Soft contact lens wear on a daily wear basis
* Able to wear lenses at least 8 hours
* Generally healthy with normal ocular health

Exclusion Criteria

* Use of additional lens cleaners
* Known sensitivities to any ingredient in any of the study products
* History of ocular surgery/trauma within the last 6 months

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No