- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01679015
Evaluating Patients With Eye Allergies and Determining if There Are Also Dry Eyes
June 2, 2016 updated by: Marc R.Bloomenstein, Schwartz Laser Eye Center
Concomitant Dry Eye in Patients With Ocular Allergy: an Under Recognized and Poorly Managed Syndrome
Evaluating the percentage of patients that suffer from eye allergies and determining whether they also have dry eyes.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
250
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Arizona
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Scottsdale, Arizona, United States, 85260
- Schwartz Laser Eye Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Patients will be screened from existing patient database.
Description
Inclusion Criteria:
- Ability to give informed consent
- Males and females at least 18 years of age
- Personal history of allergic disorders including but not limited to allergic conjunctivitis, allergic rhinitis, contact dermatitis and other eczema, and asthma
- Diagnosis of allergic conjunctivitis
- Presence of any of the following signs including conjunctival redness and papillae, chemosis, red edematous eyelids, reduced tear clearance, reduced TBUT, vital staining, stringy discharge, and/or symptoms including ocular itching, burning and tearing, runny nose or itchy throat
Exclusion Criteria:
- Active ocular or systemic infection
- History of ocular infection within past 6 months
- Presence of punctal plugs
- Recent ocular surgery within past 6 months
- Current use of chemotherapeutic agents
- Presence of ocular trauma
- Inability to give informed consent
- Women who are pregnant, nursing or lactating
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Dry Eyes, Eye Allergies
Patients with ocular allergies and those with dry eyes.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Prevalence of dry eye in an allergic population presenting to a high volume optometry practice
Time Frame: up to 2 years
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up to 2 years
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Prevalence of allergic patients with moderate to severe ocular signs and symptoms
Time Frame: up to 2 years
|
up to 2 years
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Marc R Bloomenstein, O.D., Schwartz Laser Eye Center
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2012
Primary Completion (Actual)
February 1, 2014
Study Completion (Actual)
February 1, 2014
Study Registration Dates
First Submitted
August 20, 2012
First Submitted That Met QC Criteria
August 30, 2012
First Posted (Estimate)
September 5, 2012
Study Record Updates
Last Update Posted (Estimate)
June 3, 2016
Last Update Submitted That Met QC Criteria
June 2, 2016
Last Verified
January 1, 2013
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- AL-001
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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