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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
Aston University
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Grass Pollen Ocular Allergy focused on measuring Allergic conjunctivitis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

First Posted
May 17, 2010
Last Updated
May 17, 2010
Sponsor
Aston University
Collaborators
National Pollen and Aerobiology Unit, Worcester
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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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