A Clinical Comparison of Two Daily Disposable Contact Lenses.

NCT ID: NCT00775021

Last Updated: 2018-06-19

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

123 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-08-31

Study Completion Date

2009-01-31

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/nelfilcon A

etafilcon A contact lens worn first and nelfilcon A contact lens worn second

Group Type ACTIVE_COMPARATOR

etafilcon A

Intervention Type DEVICE

Contact Lens

nelfilcon A

Intervention Type DEVICE

Contact Lens

nelfilcon A/etafilcon A

nelfilcon A contact lens worn first and etafilcon A contact lens second.

Group Type ACTIVE_COMPARATOR

etafilcon A

Intervention Type DEVICE

Contact Lens

nelfilcon A

Intervention Type DEVICE

Contact Lens

Interventions

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etafilcon A

Contact Lens

Intervention Type DEVICE

nelfilcon A

Contact Lens

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Age: 18 years to 45 years
* Current daily soft contact lens as habitual optical correction:
* Refraction:

* Best sphere (corrected for back vertex distance) -1.00 to -6.00D
* Cylinder 0.00 to - 0.75D
* Best spectacle corrected visual acuity of 6/9 or better in each eye
* Willingness to adhere to the instructions set in the clinical protocol
* Signature of the subject on the informed consent form

Exclusion Criteria

* Systemic or ocular allergies which might interfere with contact lens wear
* Systemic disease which might interfere with contact lens wear
* Ocular disease which might interfere with contact lens wear (e.g. hypoesthesia, insufficient lacrimal secretion)
* Use of medication which might interfere with contact lens wear
* Active ocular infection
* Use of ocular medication
* Significant ocular anomaly
* Presence of two or more corneal scars in either eye
* Pregnancy or lactation
* Any medical condition that might be prejudicial to the study
* Participated in any other clinical studies in the past month
* Currently wears monovision
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Johnson & Johnson Vision Care, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Otometry Technology Group, Ltd.

London, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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ID08-34

Identifier Type: -

Identifier Source: secondary_id

CR-0814

Identifier Type: -

Identifier Source: org_study_id

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