Grass Pollen Ocular AllergyNCT01125540
The Role of Daily Disposable Contact Lenses in Ocular Allergy
A study testing Acuvue (Standard Daily Disposable Contact Lens) and CIBA Dailies Aquacomfort Plus (Contact Lens - enhance lubricating) in people with Grass Pollen Ocular Allergy, run by Aston University at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Grass Pollen Ocular Allergy
- What is being tested?
- Acuvue (Standard Daily Disposable Contact Lens) and CIBA Dailies Aquacomfort Plus (Contact Lens - enhance lubricating)
- Type of treatment
- Medical device
- How many people
- 10 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jun 2007to Jan 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- contact lens wearer
- proven allergy to grass pollen
Who cannot join
- eye disease
- ocular medication
- allergy medication
- asthma
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Aston University
Birmingham, West Midlands, B4 7ET
About this study
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.
- Conditions
- Grass Pollen Ocular Allergy
- Being tested
- Acuvue (Standard Daily Disposable Contact Lens), CIBA Dailies Aquacomfort Plus (Contact Lens - enhance lubricating)
- Keywords
- Allergic conjunctivitis
- Medical subject headings
- Conjunctivitis, Allergic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acuvue (Standard Daily Disposable Contact Lens)Device
Also called Acuvue
CIBA Dailies Aquacomfort Plus (Contact Lens - enhance lubricating)Device
Also called CIBA Dailies Aquacomfort Plus
What is being measured
The primary outcome is the main question the study is designed to answer.
Symptoms
Subjective rating of itchyness, dryness, burning, watering and discomfort
Measured: 4 hours
Signs
Signs of bulbar, limbal and palpebtal hyperaemia and staining
Measured: 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2010 (estimated)
- Study startJun 2007
- Primary completionJan 2010
- Study completionJan 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Grass Pollen Ocular AllergyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aston University
- Sponsor type
- University, hospital or other
- Collaborators
- National Pollen and Aerobiology Unit, Worcester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01125540
- Sponsor's protocol ID
- Allergy02
- Status last verified
- May 2010
- First submitted
- 17 May 2010
- Last updated
- 18 May 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 21530362
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Daily Disposable Contact Lenses in Ocular Allergy
- ClinicalTrials.gov ID
- NCT01125540
- Acronym / sponsor ID
- Allergy02
- Conditions
- Grass Pollen Ocular Allergy
- Keywords
- Allergic conjunctivitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Aston UniversityUniversity, hospital or other
- Collaborators
- National Pollen and Aerobiology Unit, Worcester
- Study start
- Jun 2007
- Primary completion
- Jan 2010 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 18 May 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- contact lens wearer
- proven allergy to grass pollen
Key exclusion criteria (4 listed)
- eye disease
- ocular medication
- allergy medication
- asthma
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acuvue (Standard Daily Disposable Contact Lens)Also: Acuvue | Device | – |
| CIBA Dailies Aquacomfort Plus (Contact Lens - enhance lubricating)Also: CIBA Dailies Aquacomfort Plus | Device | – |
Primary outcome
Symptoms
Time frame: 4 hours
Subjective rating of itchyness, dryness, burning, watering and discomfort
Signs
Time frame: 4 hours
Signs of bulbar, limbal and palpebtal hyperaemia and staining
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2010.
- Derived from this study: PubMed 21530362Wolffsohn 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.
Related trials for Grass Pollen Ocular Allergy
RecruitingObservational study
Investigating Nasal and Ocular Immune Response to Conjunctival Allergen Exposure
Allergic Rhinoconjunctivitis
Active, not recruitingObservational study
Tyrosine Allergoid Paediatric and Adult Study
Allergic Rhinitis Due to Pollen, Allergic Conjunctivitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acuvue (Standard Daily Disposable Contact Lens) and CIBA Dailies Aquacomfort Plus (Contact Lens - enhance lubricating) in people with Grass Pollen Ocular Allergy, run by Aston University at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 May 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Symptoms (time frame: 4 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01125540, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2010.