Allergic RhinoconjunctivitisABC CACNCT00985296
Conjunctival Allergen Challenge (CAC) Following Allergen Exposure in the Allergen BioCube (ABC)
An observational study of Allergic Rhinoconjunctivitis, run by ORA, Inc. at 1 site in United States.
Trial summary
To evaluate the effect of Conjunctival Allergen Challenge (CAC) with Dust Mites on nasal and ocular allergic symptoms following allergen exposure in the Allergen BioCube (ABC). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Allergic Rhinoconjunctivitis
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2009to Aug 2010
- Phase
- Observational
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Subjects will be 18 years of age or older with a positive history of ocular and nasal allergy and a positive skin test reaction to ragweed within the past 24 months.
Who may be able to join
- be at least 18 years of age;
- if female, cannot be pregnant or nursing;
- have a history of ocular and nasal allergy;
- have a positive skin test reaction to ragweed within the past 24 months;
- may/may not have a positive skin test reaction to dust mites within the past 24 months
Who cannot join
- have a history of mild persistent, moderate or severe asthma within the preceding 5 years according to the National Heart, Blood and Lung Institute classification;
- have a compromised lung function;
- have any ocular condition that could affect the subject's health or the study parameters;
- have any presence of active ocular or sinus infection;
- have significant nasal conditions;
- have any significant illness that could be expected to interfere with the subject's health or with the study parameters;
- use specified disallowed medications (topical, topical ophthalmic, systemic and/or injectable treatments and all anti-allergy therapies) during the study or appropriate pre-study washout period;
- have used an investigational drug or device within 30 days of starting the study or be concurrently enrolled in another investigational drug or device study within 30 days of the study;
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pilot Study Evaluating the Effect of Conjunctival Allergen Challenge (CAC) on Nasal and Ocular Allergic Symptoms Following Allergen Exposure in the Allergen BioCube (ABC) in Subjects With Seasonal Allergic Rhinoconjunctivitis
To evaluate the effect of Conjunctival Allergen Challenge (CAC) with Dust Mites on nasal and ocular allergic symptoms following allergen exposure in the Allergen BioCube (ABC).
- Conditions
- Allergic Rhinoconjunctivitis
- Keywords
- Allergic rhinitis, Allergic conjunctivitis
- Medical subject headings
- Rhinitis, Allergic, Conjunctivitis, Allergic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Ragweed+ Dust Mite+ CAC w/ DM | Not described | |
| Ragweed + Dust Mite + CAC w/Saline | Not described | |
| Ragweed + Dust Mite - CAC | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ocular Itching
Measured: At specified timepoints for up to 2 hours
Conjunctival Redness
Measured: At specified timepoints for up to 2 hours
Total Ocular Symptom Score (TOSS) of ocular itching and redness
Measured: At specified timepoints for up to 2 hours
Total Nasal Symptom Score (TNSS) of nasal symptoms
Measured: At specified timepoints for up to 2 hours
Nasal itching, Sneezing, Rhinorrhea, and Nasal Congestion
Measured: At specified timepoints for up to 2 hours
Secondary outcomes (3)
Ciliary and episcleral redness
Measured: At specified timepoints for up to 2 hours
Chemosis
Measured: At specified timepoints for up to 2 hours
Lid Swelling
Measured: At specified timepoints for up to 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2009 (estimated)
- Study startSep 2009
- Primary completionAug 2010
- Study completionAug 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Allergic RhinoconjunctivitisStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ORA, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Paul Gomes, MS, Study director, ORA, Inc.Henry J. Crampton, MD, Principal investigator, ORA, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00985296
- Sponsor's protocol ID
- 09-003-24
- Acronym
- ABC CAC
- Status last verified
- Sep 2010
- First submitted
- 25 Sep 2009
- Last updated
- 21 Sep 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study Evaluating the Effect of Conjunctival Allergen Challenge (CAC) on Nasal and Ocular Allergic Symptoms Following Allergen Exposure in the Allergen BioCube (ABC) in Subjects With Seasonal Allergic Rhinoconjunctivitis
- ClinicalTrials.gov ID
- NCT00985296
- Acronym / sponsor ID
- ABC CAC / 09-003-24
- Conditions
- Allergic Rhinoconjunctivitis
- Keywords
- Allergic rhinitis, Allergic conjunctivitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- ORA, Inc.Industry (pharma, biotech, devices)
- Study start
- Sep 2009
- Primary completion
- Aug 2010 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 28 Sep 2009 (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.
To evaluate the effect of Conjunctival Allergen Challenge (CAC) with Dust Mites on nasal and ocular allergic symptoms following allergen exposure in the Allergen BioCube (ABC).
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Ragweed+ Dust Mite+ CAC w/ DM | – | – |
| Ragweed + Dust Mite + CAC w/Saline | – | – |
| Ragweed + Dust Mite - CAC | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects will be 18 years of age or older with a positive history of ocular and nasal allergy and a positive skin test reaction to ragweed within the past 24 months.
Key inclusion criteria (5 listed)
- be at least 18 years of age;
- if female, cannot be pregnant or nursing;
- have a history of ocular and nasal allergy;
- have a positive skin test reaction to ragweed within the past 24 months;
- may/may not have a positive skin test reaction to dust mites within the past 24 months
Key exclusion criteria (8 listed)
- have a history of mild persistent, moderate or severe asthma within the preceding 5 years according to the National Heart, Blood and Lung Institute classification;
- have a compromised lung function;
- have any ocular condition that could affect the subject's health or the study parameters;
- have any presence of active ocular or sinus infection;
- have significant nasal conditions;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Ocular Itching
Time frame: At specified timepoints for up to 2 hours
Conjunctival Redness
Time frame: At specified timepoints for up to 2 hours
Total Ocular Symptom Score (TOSS) of ocular itching and redness
Time frame: At specified timepoints for up to 2 hours
Total Nasal Symptom Score (TNSS) of nasal symptoms
Time frame: At specified timepoints for up to 2 hours
Nasal itching, Sneezing, Rhinorrhea, and Nasal Congestion
Time frame: At specified timepoints for up to 2 hours
3 secondary outcomes
Ciliary and episcleral redness
Time frame: At specified timepoints for up to 2 hours
Chemosis
Time frame: At specified timepoints for up to 2 hours
Lid Swelling
Time frame: At specified timepoints for up to 2 hours
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 21 Sep 2010.
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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.
Paul Gomes, MS study director
ORA, Inc.
Henry J. Crampton, MD principal investigator
ORA, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Allergic Rhinoconjunctivitis, run by ORA, Inc. at 1 site in United States.
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 5 inclusion and 8 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 21 Sep 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 States. 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?
Ocular Itching (time frame: At specified timepoints for up to 2 hours). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Sep 2010.