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Comparison of Two Marketed Silicone Hydrogel Lenses

NCT ID: NCT02495948

Last Updated: 2016-12-28

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

168 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-07-31

Study Completion Date

2015-10-31

Brief Summary

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The purpose of this study is to evaluate cholesterol sorption by AIR OPTIX® AQUA lenses compared to ULTRA lenses after 30 days of wear.

Detailed Description

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Conditions

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Refractive Error

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Blinding Strategy

SINGLE

Participants

Study Groups

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AOA then ULTRA

Lotrafilcon B contact lenses worn first, followed by samfilcon A contact lenses. Each product worn bilaterally (in both eyes) for a minimum of 5 days/week, 8 hours/day for 30 days in a daily wear modality.

Group Type OTHER

Lotrafilcon B contact lenses

Intervention Type DEVICE

Samfilcon A contact lenses

Intervention Type DEVICE

Hydrogen peroxide solution

Intervention Type DEVICE

Used as a cleaning, disinfection, and storage solution for silicone hydrogel and soft contact lenses

Saline solution

Intervention Type DEVICE

Used for rinsing contact lenses, as needed

ULTRA then AOA

Samfilcon A contact lenses worn first, followed by lotrafilcon B contact lenses. Each product worn bilaterally for a minimum of 5 days/week, 8 hours/day for 30 days in a daily wear modality.

Group Type OTHER

Lotrafilcon B contact lenses

Intervention Type DEVICE

Samfilcon A contact lenses

Intervention Type DEVICE

Hydrogen peroxide solution

Intervention Type DEVICE

Used as a cleaning, disinfection, and storage solution for silicone hydrogel and soft contact lenses

Saline solution

Intervention Type DEVICE

Used for rinsing contact lenses, as needed

Interventions

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Lotrafilcon B contact lenses

Intervention Type DEVICE

Samfilcon A contact lenses

Intervention Type DEVICE

Hydrogen peroxide solution

Used as a cleaning, disinfection, and storage solution for silicone hydrogel and soft contact lenses

Intervention Type DEVICE

Saline solution

Used for rinsing contact lenses, as needed

Intervention Type DEVICE

Other Intervention Names

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AIR OPTIX® AQUA Bausch + Lomb ULTRA CLEAR CARE® SENSITIVE EYES® PLUS

Eligibility Criteria

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Inclusion Criteria

* Sign informed consent document;
* Vision correctable to 20/40 Snellen (feet) or better in each eye at distance with both study contact lenses;
* Willing to wear study lenses on a daily basis (minimum 5 days/week, 8 hours/day) and attend all study visits;
* Successful wear of single-vision spherical, 2-week/ monthly replacement silicone hydrogel contact lenses in both eyes daily wear during the past 2 months for a minimum of 5 days/week, 8 hours/day. (Note: Monovision is included);

Exclusion Criteria

* Any anterior segment infection, inflammation, disease or abnormality that contraindicates contact lens wear (within 7 days of enrollment, or current);
* History of herpetic keratitis, corneal surgery or irregular cornea;
* Any use of systemic or ocular medications within the past 30 days for which contact lens wear could be contraindicated as determined by the investigator;
* Monocular (only 1 eye with functional vision) or fit with only one lens;
* Current or past AIR OPTIX® AQUA or ULTRA lens wearers;
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Alcon Research

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Trial Manager, Vision Care, GCRA

Role: STUDY_DIRECTOR

Alcon, A Novartis Division

Countries

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United States

Other Identifiers

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CLA560-P001

Identifier Type: -

Identifier Source: org_study_id