Comparison of Contact Lens Maintenance Systems for Silicone Hydrogel Lenses

NCT ID: NCT00363623

Last Updated: 2008-03-21

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

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-08-31

Study Completion Date

2006-12-31

Brief Summary

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The primary purpose of this study is to investigate the performance of contact lens maintenance systems when used with silicone hydrogel contact lenses during daily wear over a period of 1 month.

Detailed Description

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Conditions

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Myopia Hyperopia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Interventions

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Silicone hydrogel contact lens

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Is correctable to at least 20/40 distance visual acuity in each eye with spherical contact lenses.
* Is an experienced soft contact lens wearer for at least 1 month.
* Has no clinically significant anterior eye findings.
* Has no other active ocular disease.

Exclusion Criteria

* Requires concurrent ocular medication.
* Eye surgery or injury within 12 weeks prior to enrolment.
* Has any systemic disease or ocular abnormality that might interfere with contact lens wear
* Has any pre-existing ocular irritation that would preclude contact lens fitting.
* PMMA lens wear previous 6 months.
* EW or CW in previous 1 month.
* Hydrogen peroxide users
* Latex sensitivity
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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CIBA VISION

INDUSTRY

Sponsor Role collaborator

University of Melbourne

OTHER

Sponsor Role lead

Principal Investigators

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Carol Lakkis, BScOptom, PhD

Role: PRINCIPAL_INVESTIGATOR

Clinical Vision Research Australia, University of Melbourne

Locations

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Clinical Vision Research Australia

Carlton, Victoria, Australia

Site Status

Countries

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Australia

Other Identifiers

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H06 009

Identifier Type: -

Identifier Source: org_study_id