Evaluation of the Performance of AIR OPTIX® COLORS

NCT ID: NCT01338402

Last Updated: 2014-02-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

47 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-04-30

Study Completion Date

2012-03-31

Brief Summary

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The purpose of this study was to assess the ocular response to and performance of the cosmetically printed silicone hydrogel contact lens AIR OPTIX® COLORS compared to FRESHLOOK® COLORBLENDS.

Detailed Description

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The study was conducted in two phases. Phase 1 was an adaptation phase where participants wore AIR OPTIX® AQUA contact lenses bilaterally (same product in both eyes) on a daily wear basis for 1 week. In Phase 2, participants wore AIR OPTIX® COLORS and FRESHLOOK® COLORBLENDS contact lenses contralaterally (different product in each eye) on a daily wear basis for 4 weeks.

Conditions

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Myopia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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AIR OPTIX® AQUA

Lotrafilcon B contact lenses worn in both eyes on a daily wear basis for one week in Phase 1.

Group Type OTHER

Lotrafilcon B contact lens

Intervention Type DEVICE

Silicone hydrogel contact lens

AIR OPTIX® COLORS

Lotrafilcon B contact lens with color randomly assigned to one eye, with phemfilcon A contact lens with color in the fellow eye for contralateral wear. Both products worn on a daily wear basis for 4 weeks in Phase 2. A replacement phemfilcon A lens was dispensed at the Week 2 visit.

Group Type EXPERIMENTAL

Lotrafilcon B contact lens with color

Intervention Type DEVICE

Silicone hydrogel contact lens with color

FRESHLOOK® COLORBLENDS

Phemfilcon A contact lens with color randomly assigned to one eye, with lotrafilcon B contact lens with color in the fellow eye for contralateral wear. Both products worn on a daily wear basis for 4 weeks in Phase 2. A replacement phemfilcon A lens was dispensed at the Week 2 visit.

Group Type ACTIVE_COMPARATOR

Phemfilcon A contact lens with color

Intervention Type DEVICE

Hydrogel contact lens with color

Interventions

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Lotrafilcon B contact lens

Silicone hydrogel contact lens

Intervention Type DEVICE

Lotrafilcon B contact lens with color

Silicone hydrogel contact lens with color

Intervention Type DEVICE

Phemfilcon A contact lens with color

Hydrogel contact lens with color

Intervention Type DEVICE

Other Intervention Names

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AIR OPTIX® AQUA AIR OPTIX® COLORS FRESHLOOK® COLORBLENDS

Eligibility Criteria

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Inclusion Criteria

* Full legal capacity to volunteer;
* Read and sign information and consent letter;
* Willing and able to follow instructions and maintain the appointment schedule;
* Ocular examination in the last two years;
* Currently wears soft contact lenses on a daily wear basis;
* Contact lens prescription between -1.50 diopters and -5.00 diopters;

Exclusion Criteria

* Any ocular disease;
* Any systemic condition that may affect a study outcome variable;
* Any systemic or topical medications that may affect ocular health;
* Known sensitivity to the diagnostic pharmaceuticals used in the study;
* Unable to achieve an acceptable fit with the study lenses;
* Anisometropia \>1.00 diopter or astigmatism \>0.75 diopter;
* Use of lubricating/rewetting eye drops.
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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Desmond Fonn, MOptom, FAAO

Role: PRINCIPAL_INVESTIGATOR

University of Waterloo Centre for Contact Lens Research

Lyndon Jones, PhD, FCOptom, FAAO

Role: PRINCIPAL_INVESTIGATOR

University of Waterloo Centre for Contact Lens Research

Locations

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Centre for Contact Lens Research, University of Waterloo

Waterloo, Ontario, Canada

Site Status

Countries

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Canada

Other Identifiers

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P/363/10/C

Identifier Type: OTHER

Identifier Source: secondary_id

P-368-C-108

Identifier Type: -

Identifier Source: org_study_id

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