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Feasibility of a New Silicone Hydrogel Lens

NCT ID: NCT01131130

Last Updated: 2014-04-30

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

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-05-31

Study Completion Date

2010-06-30

Brief Summary

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The objective of this study is to determine the product feasibility of the investigational contact lens (Test) when compared to the currently marketed Acuvue Oasys contact lens (Control) and the Air Optix Aqua contact lens (Control) when worn by adapted wearers of soft contact lenses.

Detailed Description

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Conditions

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Myopia

Keywords

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Contact lens

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Blinding Strategy

SINGLE

Participants

Study Groups

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Investigational contact lens

Bausch \& Lomb

Group Type EXPERIMENTAL

Investigational contact lens

Intervention Type DEVICE

After one week of wearing the first lens type, the participants will crossover to the second lens type for one week, and then crossover to the third lens type.

Acuvue Oasys Contact Lens

Johnson \& Johnson Lens

Group Type ACTIVE_COMPARATOR

Acuvue Oasys Contact Lens

Intervention Type DEVICE

After one week of wearing the first lens type, the participants will crossover to the second lens type for one week, and then crossover to the third lens type.

Air Optix Aqua

Ciba Vision

Group Type ACTIVE_COMPARATOR

Air Optix Aqua

Intervention Type DEVICE

After one week of wearing the first lens type, the participants will crossover to the second lens type for one week, and then crossover to the third lens type.

Interventions

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Investigational contact lens

After one week of wearing the first lens type, the participants will crossover to the second lens type for one week, and then crossover to the third lens type.

Intervention Type DEVICE

Acuvue Oasys Contact Lens

After one week of wearing the first lens type, the participants will crossover to the second lens type for one week, and then crossover to the third lens type.

Intervention Type DEVICE

Air Optix Aqua

After one week of wearing the first lens type, the participants will crossover to the second lens type for one week, and then crossover to the third lens type.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Participants must have clear central corneas and be free of any anterior segment disorders.
* Participants must be adapted wearers of soft contact lenses, wear a lens in each eye, and each lens must be of the same manufacture and brand.
* Participants must be myopic and require lens correction from -0.75 D to - 4.75D in each eye.

Exclusion Criteria

* Participants who have worn gas permeable (GP) contact lenses within the last 30 days or who have worn polymethylmethacrylate (PMMA) lenses within the last three months.
* Participants with any systemic disease affecting ocular health.
* Participants using any systemic or topical medications that will, in the Investigator's opinion, affect ocular physiology or lens performance.
* Participants with an active ocular disease or are using any ocular medication.
* Participants who have had any corneal surgery (eg, refractive surgery).
* Participants who are allergic to any component in the study care products.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bausch & Lomb Incorporated

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Gerard Carains, MCOptom, PhD

Role: STUDY_DIRECTOR

Bausch & Lomb Incorporated

Locations

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Bausch & Lomb

Rochester, New York, United States

Site Status

Countries

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United States

Other Identifiers

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655

Identifier Type: -

Identifier Source: org_study_id