The Clinical Evaluation of Two Daily Disposable Contact Lenses - Full Text View

Sponsors and Collaborators:	Vistakon Eurolens Research
Information provided by:	Vistakon
ClinicalTrials.gov Identifier:	NCT00762996

Purpose

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

Condition	Intervention
Myopia	Device: etafilcon A Device: omafilcon A

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Subject), Active Control, Crossover Assignment

Resource links provided by NLM:

MedlinePlus related topics: Eye Wear

Drug Information available for: Etafilcon A

Further study details as provided by Vistakon:

Primary Outcome Measures:

Distance Visual Acuity [ Time Frame: 1 week ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Enrollment:	65
Study Start Date:	August 2007
Study Completion Date:	October 2007
Primary Completion Date:	October 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
etafilcon A/etafilcon A: Active Comparator Period 1: etafilcon A, Period 2: etafilcon A	Device: etafilcon A contact lens
etafilcon A/omafilcon A: Active Comparator Period 1: etafilcon A, Period 2: omafilcon A	Device: etafilcon A contact lens Device: omafilcon A contact lens
omafilcon A/etafilcon A: Active Comparator Period 1: omafilcon A, Period 2: etafilcon A	Device: etafilcon A contact lens Device: omafilcon A contact lens
omafilcon A/omafilcon A: Active Comparator Period 1: omafilcon A, Period 2: omafilcon A	Device: omafilcon A contact lens

Eligibility

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00762996

Locations

United Kingdom
Eurolens Research
Manchester, United Kingdom, M60 1QD

Sponsors and Collaborators

Vistakon

Eurolens Research

More Information

No publications provided

Responsible Party:	Vistakon, Division of Johnson & Johnson Vision Care, Inc. ( Dr. Kurt Moody/Associate Director Clinical Research )
Study ID Numbers:	CR-0707, J07-418
Study First Received:	September 26, 2008
Results First Received:	October 24, 2008
Last Updated:	July 7, 2009
ClinicalTrials.gov Identifier:	NCT00762996 History of Changes
Health Authority:	United Kingdom: Research Ethics Committee

Study placed in the following topic categories:

Myopia

ClinicalTrials.gov processed this record on September 11, 2009