Allergic ConjunctivitisNCT00982163
A Single-Center Evaluation of the Pattern of Allergic Signs and Symptoms During 4 Weeks in Ragweed Season
An observational study of Allergic Conjunctivitis, run by ORA, Inc. at 1 site in United States.
Trial summary
The study was designed to evaluate the pattern of seasonal allergic signs and symptoms consistent with ongoing ocular allergic inflammation during ragweed season. It was hypothesized that a pattern of ongoing ocular allergic inflammation existed in certain subjects. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Allergic Conjunctivitis
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2008to Sep 2009
- 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: A community sample of subjects with allergic conjunctivitis and at least 18 years of age were enrolled into the study.
Who may be able to join
- Subjects must:
- be willing and able to read, sign, and date the informed consent and HIPAA documents prior to initiation of Visit 1 procedures or exams;
- be at least 18 years of age;
- be willing to avoid disallowed medication, such as anti-allergy therapies
- have a positive history of ocular allergies and a positive skin test reaction to ragweed within the past 24 months;
- have a calculated logMAR visual acuity score using the ETDRS Chart of 0.60 or better in each eye at Visit 1;
Who cannot join
- Subjects may not:
- have preauricular lymphadenopathy or any ocular condition that could affect study parameters (particularly, clinically significant blepharitis, follicular conjunctivitis and iritis);
- have had any ocular infection within the last 30 days;
- have a positive diagnosis of moderate to severe dry eye syndrome (i.e., requiring daily use of artificial tears);
- wear contact lenses to each office visit; Note: Subjects will be allowed to use cold compresses.
Trial locations and contacts
1 site in 1 country.
About this study
The study was designed to evaluate the pattern of seasonal allergic signs and symptoms consistent with ongoing ocular allergic inflammation during ragweed season. It was hypothesized that a pattern of ongoing ocular allergic inflammation existed in certain subjects.
Read the detailed description
Subjects who had a positive skin test to ragweed within 24 months of Visit 1 were instructed to complete a diary, which assessed their allergic signs and symptoms 3 times a day for 4 weeks. During the in-office visits, subjects were asked to completed a quality of life questionnaire, as well as a retrospective and/or prospective eye allergy questionnaire.
- Conditions
- Allergic Conjunctivitis
- Medical subject headings
- Conjunctivitis, Allergic
What is being measured
The primary outcome is the main question the study is designed to answer.
Diary Data
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2009 (estimated)
- Study startAug 2008
- Primary completionSep 2008
- Study completionSep 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Allergic ConjunctivitisStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- ORA, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- H. Jerome Crampton, M.D., Principal investigator, ORA, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00982163
- Sponsor's protocol ID
- 08-003-26
- Status last verified
- Sep 2009
- First submitted
- 22 Sep 2009
- Last updated
- 23 Sep 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Center Evaluation of the Pattern of Allergic Signs and Symptoms During 4 Weeks in Ragweed Season
- ClinicalTrials.gov ID
- NCT00982163
- Acronym / sponsor ID
- 08-003-26
- Conditions
- Allergic Conjunctivitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- ORA, Inc.Industry (pharma, biotech, devices)
- Study start
- Aug 2008
- Primary completion
- Sep 2008 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 23 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.
The study was designed to evaluate the pattern of seasonal allergic signs and symptoms consistent with ongoing ocular allergic inflammation during ragweed season. It was hypothesized that a pattern of ongoing ocular allergic inflammation existed in certain subjects.
Detailed description
Subjects who had a positive skin test to ragweed within 24 months of Visit 1 were instructed to complete a diary, which assessed their allergic signs and symptoms 3 times a day for 4 weeks. During the in-office visits, subjects were asked to completed a quality of life questionnaire, as well as a retrospective and/or prospective eye allergy questionnaire.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- A community sample of subjects with allergic conjunctivitis and at least 18 years of age were enrolled into the study.
Key inclusion criteria (6 listed)
- Subjects must:
Key exclusion criteria (5 listed)
- Subjects may not:
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
Diary Data
Time frame: 4 weeks
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 23 Sep 2009.
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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.
H. Jerome Crampton, M.D. 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 Conjunctivitis, 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 6 inclusion and 5 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 23 Sep 2009. 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?
Diary Data (time frame: 4 weeks). 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 23 Sep 2009.