The Clinical Evaluation of Two Daily Disposable Contact Lenses

NCT ID: NCT00762996

Last Updated: 2018-06-19

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

65 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-08-31

Study Completion Date

2007-10-31

Brief Summary

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The objective of this study is to evaluate the clinical performance of two daily disposable contact lenses.

Detailed Description

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Conditions

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Myopia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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etafilcon A/etafilcon A

Period 1: etafilcon A, Period 2: etafilcon A

Group Type ACTIVE_COMPARATOR

etafilcon A

Intervention Type DEVICE

contact lens

etafilcon A/omafilcon A

Period 1: etafilcon A, Period 2: omafilcon A

Group Type ACTIVE_COMPARATOR

etafilcon A

Intervention Type DEVICE

contact lens

omafilcon A

Intervention Type DEVICE

contact lens

omafilcon A/etafilcon A

Period 1: omafilcon A, Period 2: etafilcon A

Group Type ACTIVE_COMPARATOR

etafilcon A

Intervention Type DEVICE

contact lens

omafilcon A

Intervention Type DEVICE

contact lens

omafilcon A/omafilcon A

Period 1: omafilcon A, Period 2: omafilcon A

Group Type ACTIVE_COMPARATOR

omafilcon A

Intervention Type DEVICE

contact lens

Interventions

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etafilcon A

contact lens

Intervention Type DEVICE

omafilcon A

contact lens

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* They are of legal age (18 years) and capacity to volunteer.
* They understand their rights as a research subject and are willing to sign a Statement of Informed Consent.
* They are willing and able to follow the protocol.
* They would be expected to attain at least 6.9 (20/30) in each eye with the study lenses.
* They are able to wear contact lenses which have a back vertex power of -1.00 to -6.00DS.
* They have a maximum of 1.00D of refractive astigmatism (i.e. \< 1.00 DC).
* They have worn soft contact lenses within six months of starting the study.

Exclusion Criteria

* They have an ocular disorder which would normally contra-indicate contact lens wear.
* They have a systemic disorder which would normally contra-indicate contact lens wear.
* They are using any topical medication such as eye drops or ointment.
* They are aphakic.
* They have had corneal refractive surgery.
* They have any corneal distortion resulting from previous hard or rigid lens wear or has keratoconus.
* They are pregnant or lactating.
* They have grade 2 or greater of any of the following ocular surface signs: corneal edema, corneal vascularization, corneal staining, tarsal conjunctival changes or any other abnormality which would normally contraindicate contact lens wear.
* They have any infectious disease (e.g., hepatitis) or any immunosuppressive disease (e.g., HIV).
* They have diabetes.
* They are currently taking part in any other clinical study or research.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Eurolens Research

INDUSTRY

Sponsor Role collaborator

Johnson & Johnson Vision Care, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Eurolens Research

Manchester, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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CR-0707

Identifier Type: -

Identifier Source: org_study_id

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