Lens Wear Schedules and End-of-Day Comfort

NCT ID: NCT01433549

Last Updated: 2013-05-06

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-08-31

Study Completion Date

2012-03-31

Brief Summary

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The purpose of this study was to assess the impact of lens-free (recovery) intervals of varying lengths on end-of-day comfort and tear film changes with daily contact lens wear.

Detailed Description

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This study was conducted in a cross-over design with two phases. Each phase consisted of four cycles approximately 12 hours in length. During each cycle, contact lenses were worn for 2-hour intervals, separated by lens-free (recovery) intervals of either 0, 30, 60, or 80 minutes. A new pair of contact lenses was dispensed for each 2-hour interval of lens wear. A 12-hour lens-free wear period preceded each phase.

Conditions

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Myopia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

Study Groups

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Lotrafilcon B / Senofilcon A

Lotrafilcon B worn first, with senofilcon A worn second, as randomized. Each product was worn bilaterally in 2-hour intervals, separated by lens-free (recovery) intervals of either 0, 30, 60, or 80 minutes, over the course of a 12-hour day, for a total of 4 cycles (days).

Group Type OTHER

Lotrafilcon B

Intervention Type DEVICE

Commercially marketed, silicone hydrogel, single-vision contact lens FDA-approved for daily wear and extended (overnight) wear up to 6 nights.

Senofilcon A

Intervention Type DEVICE

Commercially marketed, silicone hydrogel, single-vision contact lens FDA-approved for daily wear and extended (overnight) wear up to 6 nights.

Senofilcon A / Lotrafilcon B

Senofilcon A worn first, with lotrafilcon B worn second, as randomized. Each product was worn bilaterally in 2-hour intervals, separated by lens-free (recovery) intervals of either 0, 30, 60, or 80 minutes, over the course of a 12-hour day, for a total of 4 cycles (days).

Group Type OTHER

Lotrafilcon B

Intervention Type DEVICE

Commercially marketed, silicone hydrogel, single-vision contact lens FDA-approved for daily wear and extended (overnight) wear up to 6 nights.

Senofilcon A

Intervention Type DEVICE

Commercially marketed, silicone hydrogel, single-vision contact lens FDA-approved for daily wear and extended (overnight) wear up to 6 nights.

Interventions

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Lotrafilcon B

Commercially marketed, silicone hydrogel, single-vision contact lens FDA-approved for daily wear and extended (overnight) wear up to 6 nights.

Intervention Type DEVICE

Senofilcon A

Commercially marketed, silicone hydrogel, single-vision contact lens FDA-approved for daily wear and extended (overnight) wear up to 6 nights.

Intervention Type DEVICE

Other Intervention Names

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AIR OPTIX® AQUA ACUVUE® OASYS®

Eligibility Criteria

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Inclusion Criteria

* Is at least 17 years of age and has full legal capacity to volunteer.
* Is willing and able to follow instructions and maintain the appointment schedule.
* Has had an ocular examination in the last two years.
* Is an adapted soft contact lens wearer.
* Experiences a decrease in ocular comfort through a lens-wearing day.
* Has a current pair of spectacles.
* Has a distance contact lens prescription of +6.00 diopters to -10.00 diopters and an acceptable fit with the study lenses.
* Has astigmatism less than or equal to -1.00 DC.
* Achieves visual acuity of 6/9 or better with the study lenses and with habitual spectacles.

Exclusion Criteria

* Has any ocular disease.
* Has a systemic condition that may affect a study outcome variable.
* Is using any systemic or topical medications that may affect ocular health.
* Has known sensitivity to the diagnostic pharmaceuticals to be used in the study.
Minimum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Waterloo

OTHER

Sponsor Role collaborator

CIBA VISION

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Lyndon Jones, PhD FCOptom FAAO, Director

Role: PRINCIPAL_INVESTIGATOR

Centre for Contact Lens Research, School of Optometry, University of Waterloo

Locations

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University of Waterloo Centre for Contact Lens Research

Waterloo, Ontario, Canada

Site Status

Countries

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Canada

References

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Stahl U, Keir NJ, Landers A, Jones LW. Effect of Short Recovery Periods on Ocular Comfort During Daily Lens Wear. Optom Vis Sci. 2016 Aug;93(8):861-71. doi: 10.1097/OPX.0000000000000912.

Reference Type DERIVED
PMID: 27362613 (View on PubMed)

Other Identifiers

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P-373-C-104

Identifier Type: -

Identifier Source: org_study_id

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