The Role of Daily Disposable Contact Lenses in Ocular Allergy
Primary Purpose
Grass Pollen Ocular Allergy
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Acuvue (Standard Daily Disposable Contact Lens)
CIBA Dailies Aquacomfort Plus (Contact Lens - enhance lubricating)
Sponsored by
About this trial
This is an interventional prevention trial for Grass Pollen Ocular Allergy focused on measuring Allergic conjunctivitis
Eligibility Criteria
Inclusion Criteria:
- contact lens wearer
- proven allergy to grass pollen
Exclusion Criteria:
- eye disease
- ocular medication
- allergy medication
- asthma
Sites / Locations
- Aston University
Outcomes
Primary Outcome Measures
Symptoms
Subjective rating of itchyness, dryness, burning, watering and discomfort
Signs
Signs of bulbar, limbal and palpebtal hyperaemia and staining
Secondary Outcome Measures
Full Information
NCT ID
NCT01125540
First Posted
May 17, 2010
Last Updated
May 17, 2010
Sponsor
Aston University
Collaborators
National Pollen and Aerobiology Unit, Worcester
1. Study Identification
Unique Protocol Identification Number
NCT01125540
Brief Title
The Role of Daily Disposable Contact Lenses in Ocular Allergy
Official Title
The Role of Daily Disposable Contact Lenses in Ocular Allergy
Study Type
Interventional
2. Study Status
Record Verification Date
May 2010
Overall Recruitment Status
Completed
Study Start Date
June 2007 (undefined)
Primary Completion Date
January 2010 (Actual)
Study Completion Date
January 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Aston University
Collaborators
National Pollen and Aerobiology Unit, Worcester
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Grass Pollen Ocular Allergy
Keywords
Allergic conjunctivitis
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
Acuvue (Standard Daily Disposable Contact Lens)
Other Intervention Name(s)
Acuvue
Intervention Type
Device
Intervention Name(s)
CIBA Dailies Aquacomfort Plus (Contact Lens - enhance lubricating)
Other Intervention Name(s)
CIBA Dailies Aquacomfort Plus
Primary Outcome Measure Information:
Title
Symptoms
Description
Subjective rating of itchyness, dryness, burning, watering and discomfort
Time Frame
4 hours
Title
Signs
Description
Signs of bulbar, limbal and palpebtal hyperaemia and staining
Time Frame
4 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
contact lens wearer
proven allergy to grass pollen
Exclusion Criteria:
eye disease
ocular medication
allergy medication
asthma
Facility Information:
Facility Name
Aston University
City
Birmingham
State/Province
West Midlands
ZIP/Postal Code
B4 7ET
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
21530362
Citation
Wolffsohn JS, Emberlin JC. Role of contact lenses in relieving ocular allergy. Cont Lens Anterior Eye. 2011 Aug;34(4):169-72. doi: 10.1016/j.clae.2011.03.004. Epub 2011 May 6.
Results Reference
derived
Learn more about this trial
The Role of Daily Disposable Contact Lenses in Ocular Allergy
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