Three Month Clinical Evaluation of the Contamac 74% Silicone Hydrogel Contact Lens

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

57 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-08-31

Study Completion Date

2009-02-28

Brief Summary

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The purpose of this study is to compare the clinical performance of the contamac silicone hydrogel contact lens with a predicate device (Cooper Vision Biofinity).

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Detailed Description

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The purpose of this study is to evaluate the clinical performance of the Contamac lens in comparison with a currently marketed silicone hydrogel: Biofinity® (CooperVision). This is a 3-month, open-label, bilateral, parallel group, randomised, daily wear study. Approx. two-thirds of the subjects will wear the Contamac Silicone Hydrogel lens in both eyes while the other third will wear control lenses.

Conditions

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Vision Correction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Contamac 74% silicone hydrogel contact lens

Definitive Contact Lens

Group Type ACTIVE_COMPARATOR

Definitive Contact Lens

Intervention Type DEVICE

Daily wear contact lens

Cooper Vision Biofinity

Biofinity Contact Lens

Group Type PLACEBO_COMPARATOR

Biofinity

Intervention Type DEVICE

Daily wear contact lens

Interventions

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Definitive Contact Lens

Daily wear contact lens

Intervention Type DEVICE

Biofinity

Daily wear contact lens

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* existing contact lens wearer
* read and signed statement of informed consent
* has clear central cornea
* requires spherical distance correction

Exclusion Criteria

* has worn RGP contact lenses within the last 30 days
* is using any ocular medication
* has had refractive surgery
* has an infectious disease
* is pregnant or lactating
* is participating in another clinical research study

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes