Dry EyesNCT01679015
Evaluating Patients With Eye Allergies and Determining if There Are Also Dry Eyes
An observational study of Dry Eyes and Allergic Conjunctivitis, run by Schwartz Laser Eye Center at 1 site in United States.
Trial summary
Evaluating the percentage of patients that suffer from eye allergies and determining whether they also have dry eyes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dry Eyes, Allergic Conjunctivitis
- How many people
- 250 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2012to Feb 2014
- 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: Patients will be screened from existing patient database.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Schwartz Laser Eye Center
Scottsdale, Arizona, 85260
About this study
Official title: 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.
- Conditions
- Dry Eyes, Allergic Conjunctivitis
- Keywords
- Burning, Dryness, Itching, Blurry Vision
- Medical subject headings
- Dry Eye Syndromes, Conjunctivitis, Allergic, Paresthesia, Pruritus
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 |
|---|---|---|
| Dry Eyes, Eye Allergies | Patients with ocular allergies and those with dry eyes. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of dry eye in an allergic population presenting to a high volume optometry practice
Measured: up to 2 years
Secondary outcomes (1)
Prevalence of allergic patients with moderate to severe ocular signs and symptoms
Measured: up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2012 (estimated)
- Study startAug 2012
- Primary completionFeb 2014
- Study completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry EyesStudies 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 only
- Time perspective
- Prospective
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- Schwartz Laser Eye Center
- Sponsor type
- University, hospital or other
- Collaborators
- Allergan
- Responsible party
- Principal investigator, Marc R.Bloomenstein, Schwartz Laser Eye Center
- Investigators
- Marc R Bloomenstein, O.D., Principal investigator, Schwartz Laser Eye Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01679015
- Sponsor's protocol ID
- AL-001
- Status last verified
- Jan 2013
- First submitted
- 20 Aug 2012
- Last updated
- 3 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Concomitant Dry Eye in Patients With Ocular Allergy: an Under Recognized and Poorly Managed Syndrome
- ClinicalTrials.gov ID
- NCT01679015
- Acronym / sponsor ID
- AL-001
- Conditions
- Dry Eyes, Allergic Conjunctivitis
- Keywords
- Burning, Dryness, Itching, Blurry Vision
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- Schwartz Laser Eye CenterUniversity, hospital or other
- Collaborators
- Allergan
- Study start
- Aug 2012
- Primary completion
- Feb 2014 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 5 Sep 2012 (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.
Evaluating the percentage of patients that suffer from eye allergies and determining whether they also have dry eyes.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dry Eyes, Eye Allergies | – | –Patients with ocular allergies and those with dry eyes. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients will be screened from existing patient database.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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
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
Prevalence of dry eye in an allergic population presenting to a high volume optometry practice
Time frame: up to 2 years
1 secondary outcome
Prevalence of allergic patients with moderate to severe ocular signs and symptoms
Time frame: up to 2 years
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 3 Jun 2016.
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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.
Marc R Bloomenstein, O.D. principal investigator
Schwartz Laser Eye Center
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 Dry Eyes and Allergic Conjunctivitis, run by Schwartz Laser Eye Center 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 3 Jun 2016. 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?
Prevalence of dry eye in an allergic population presenting to a high volume optometry practice (time frame: up to 2 years). 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 3 Jun 2016.