A Comparison of Two Daily Disposable Contact Lenses. - Full Text View

Sponsors and Collaborators:	Vistakon Visioncare Research Ltd.
Information provided by:	Vistakon
ClinicalTrials.gov Identifier:	NCT00721500

Purpose

This study seeks to evaluate the clinical fitting performance of a new CE marked daily disposable contact lens to an existing daily disposable contact lens.

Condition	Intervention
Refractive Error Myopia	Device: etafilcon A Device: narafilcon A

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Crossover Assignment

Resource links provided by NLM:

MedlinePlus related topics: Eye Wear Refractive Errors

Drug Information available for: Etafilcon A

U.S. FDA Resources

Further study details as provided by Vistakon:

Primary Outcome Measures:

Fit characteristics [ Time Frame: after 30 minutes of wear ] [ Designated as safety issue: No ]

Enrollment:	25
Study Start Date:	June 2008
Study Completion Date:	July 2008
Primary Completion Date:	July 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator contact lens	Device: etafilcon A contact lens
2: Experimental contact lens	Device: narafilcon A contact lens

Eligibility

Ages Eligible for Study:	18 Years to 60 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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 with 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 successfully worn 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 oedema, corneal vascularisation, 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 have taken part in any other clinical trial or research, within two weeks prior to starting this study.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00721500

Locations

United Kingdom, Surrey
Visioncare Research Ltd
Farnham, Surrey, United Kingdom, GU9 7EN

Sponsors and Collaborators

Vistakon

Visioncare Research Ltd.

More Information

No publications provided

Responsible Party:	Vistakon ( Kurt Moody, OD, FAOO / Associate Director, Clinical Research )
Study ID Numbers:	CR-0812, PROD-502
Study First Received:	July 22, 2008
Last Updated:	August 14, 2008
ClinicalTrials.gov Identifier:	NCT00721500 History of Changes
Health Authority:	United Kingdom: Research Ethics Committee

Study placed in the following topic categories:

Eye Diseases
Myopia
Refractive Errors

Additional relevant MeSH terms:

Eye Diseases
Refractive Errors

ClinicalTrials.gov processed this record on September 09, 2009