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Effect of Contact Lenses on Tear Osmolarity in a Controlled Low Humidity Chamber

NCT ID: NCT01482312

Last Updated: 2012-07-27

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

29 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-12-31

Study Completion Date

2011-02-28

Brief Summary

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The purpose of this study is to evaluate two different types of contact lenses and their effect on dry eyes when compared to wearing glasses in a controlled, low humidity chamber.

Detailed Description

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Conditions

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Myopia Dry Eye

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Lotrafilcon A / Comfilcon A / Glasses

Lotrafilcon A contact lenses worn first, followed by comfilcon A contact lenses, followed by habitual glasses. Each product worn for 90 minutes in a controlled, low-humidity environment (LHE) chamber. Each period separated by a washout of approximately 7 days.

Group Type ACTIVE_COMPARATOR

lotrafilcon A contact lenses

Intervention Type DEVICE

Commercially marketed, silicone hydrogel, single-vision, soft contact lenses FDA-approved for daily and extended (overnight) wear for up to 30 nights of continuous wear.

comfilcon A contact lenses

Intervention Type DEVICE

Commercially marketed, silicone hydrogel, single-vision, soft contact lenses FDA-approved for daily and extended (overnight) wear for up to 30 nights of continuous wear.

Glasses

Intervention Type OTHER

Glasses per habitual prescription

comfilcon A / glasses / lotrafilcon A

Comfilcon A contact lenses worn first, followed by glasses, followed by lotrafilcon A contact lenses. Each product worn for 90 minutes in a controlled, low-humidity environment (LHE) chamber. Each period separated by a washout of approximately 7 days.

Group Type ACTIVE_COMPARATOR

lotrafilcon A contact lenses

Intervention Type DEVICE

Commercially marketed, silicone hydrogel, single-vision, soft contact lenses FDA-approved for daily and extended (overnight) wear for up to 30 nights of continuous wear.

comfilcon A contact lenses

Intervention Type DEVICE

Commercially marketed, silicone hydrogel, single-vision, soft contact lenses FDA-approved for daily and extended (overnight) wear for up to 30 nights of continuous wear.

Glasses

Intervention Type OTHER

Glasses per habitual prescription

glasses / lotrafilcon A / comfilcon A

Glasses worn first, followed by lotrafilcon A contact lenses, followed by comfilcon A contact lenses. Each product worn for 90 minutes in a controlled, low-humidity environment (LHE) chamber. Each period separated by a washout of approximately 7 days.

Group Type ACTIVE_COMPARATOR

lotrafilcon A contact lenses

Intervention Type DEVICE

Commercially marketed, silicone hydrogel, single-vision, soft contact lenses FDA-approved for daily and extended (overnight) wear for up to 30 nights of continuous wear.

comfilcon A contact lenses

Intervention Type DEVICE

Commercially marketed, silicone hydrogel, single-vision, soft contact lenses FDA-approved for daily and extended (overnight) wear for up to 30 nights of continuous wear.

Glasses

Intervention Type OTHER

Glasses per habitual prescription

Interventions

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lotrafilcon A contact lenses

Commercially marketed, silicone hydrogel, single-vision, soft contact lenses FDA-approved for daily and extended (overnight) wear for up to 30 nights of continuous wear.

Intervention Type DEVICE

comfilcon A contact lenses

Commercially marketed, silicone hydrogel, single-vision, soft contact lenses FDA-approved for daily and extended (overnight) wear for up to 30 nights of continuous wear.

Intervention Type DEVICE

Glasses

Glasses per habitual prescription

Intervention Type OTHER

Other Intervention Names

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Air Optix Night and Day AQUA Biofinity

Eligibility Criteria

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Inclusion Criteria

* Age 18 to 70.
* History of end-of-day or low-humidity dryness with contact lenses.
* Healthy eyes.
* Best-corrected visual acuity of 20/50 or better for each eye.
* Usable pair of eye glasses.
* Willing and able to attend required study visits.
* Sign informed consent.

Exclusion Criteria

* Ocular or systemic allergies or diseases which might interfere with contact lens wear.
* Clinically significant ocular findings which would contraindicate contact lens wear.
* Unable to abstain from artificial tears or other ophthalmic drops for at least 7 days.
* Participation in another clinical study currently or within 30 days of study entry.
* Spectacle astigmatism of \>1.00 diopter.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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CIBA VISION

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Deepen Patel, MD, CCFP

Role: PRINCIPAL_INVESTIGATOR

Cetero Research, San Antonio

Locations

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Cetero Research

Mississauga, Ontario, Canada

Site Status

Countries

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Canada

Other Identifiers

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P-373-C-900

Identifier Type: -

Identifier Source: org_study_id