The Role of Daily Disposable Contact Lenses in Ocular Allergy

This study has been completed.

Sponsor:

Collaborator:

National Pollen and Aerobiology Unit, Worcester

Information provided by:

Aston University

ClinicalTrials.gov Identifier:

NCT01125540

First received: May 17, 2010

Last updated: NA

Last verified: May 2010

History: No changes posted

Tracking Information
First Received Date ^ICMJE	May 17, 2010
Last Updated Date	May 17, 2010
Start Date ^ICMJE	June 2007
Primary Completion Date	January 2010 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: May 17, 2010)	Symptoms [ Time Frame: 4 hours ] [ Designated as safety issue: No ] Subjective rating of itchyness, dryness, burning, watering and discomfort Signs [ Time Frame: 4 hours ] [ Designated as safety issue: No ] Signs of bulbar, limbal and palpebtal hyperaemia and staining
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	No Changes Posted
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	The Role of Daily Disposable Contact Lenses in Ocular Allergy
Official Title ^ICMJE	The Role of Daily Disposable Contact Lenses in Ocular Allergy
Brief Summary	Patients with seasonal allergic conjunctivitis are normally advised to avoid contact lens wear when they are having symptoms. However, modern soft contact lenses which are disposed of daily offer the potential to protect and lubricate the ocular surface. This study examines this possible effect.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Not Provided
Study Design ^ICMJE	Allocation: Randomized Intervention Model: Single Group Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Prevention
Condition ^ICMJE	Grass Pollen Ocular Allergy
Intervention ^ICMJE	Device: Acuvue (Standard Daily Disposable Contact Lens) Other Name: Acuvue Device: CIBA Dailies Aquacomfort Plus (Contact Lens - enhance lubricating) Other Name: CIBA Dailies Aquacomfort Plus
Study Arm (s)	Not Provided
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	10
Completion Date	January 2010
Primary Completion Date	January 2010 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: contact lens wearer proven allergy to grass pollen Exclusion Criteria: eye disease ocular medication allergy medication asthma
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United Kingdom

Administrative Information
NCT Number ^ICMJE	NCT01125540
Other Study ID Numbers ^ICMJE	Allergy02
Has Data Monitoring Committee	No
Responsible Party	Prof James Wolffsohn, Aston University
Study Sponsor ^ICMJE	Aston University
Collaborators ^ICMJE	National Pollen and Aerobiology Unit, Worcester
Investigators ^ICMJE	Not Provided
Information Provided By	Aston University
Verification Date	May 2010
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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