Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Evaluating Patients With Eye Allergies and Determining if There Are Also Dry Eyes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01679015
Recruitment Status : Completed
First Posted : September 5, 2012
Last Update Posted : June 3, 2016
Sponsor:
Collaborator:
Allergan
Information provided by (Responsible Party):
Marc R.Bloomenstein, Schwartz Laser Eye Center

Tracking Information
First Submitted Date August 20, 2012
First Posted Date September 5, 2012
Last Update Posted Date June 3, 2016
Study Start Date August 2012
Actual Primary Completion Date February 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: August 30, 2012)
Prevalence of dry eye in an allergic population presenting to a high volume optometry practice [ Time Frame: up to 2 years ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: August 30, 2012)
Prevalence of allergic patients with moderate to severe ocular signs and symptoms [ Time Frame: up to 2 years ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Evaluating Patients With Eye Allergies and Determining if There Are Also Dry Eyes
Official Title Concomitant Dry Eye in Patients With Ocular Allergy: an Under Recognized and Poorly Managed Syndrome
Brief Summary Evaluating the percentage of patients that suffer from eye allergies and determining whether they also have dry eyes.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Patients will be screened from existing patient database.
Condition
  • Dry Eyes
  • Allergic Conjunctivitis
Intervention Not Provided
Study Groups/Cohorts Dry Eyes, Eye Allergies
Patients with ocular allergies and those with dry eyes.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: August 30, 2012)
250
Original Estimated Enrollment Same as current
Actual Study Completion Date February 2014
Actual Primary Completion Date February 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01679015
Other Study ID Numbers AL-001
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Marc R.Bloomenstein, Schwartz Laser Eye Center
Study Sponsor Schwartz Laser Eye Center
Collaborators Allergan
Investigators
Principal Investigator: Marc R Bloomenstein, O.D. Schwartz Laser Eye Center
PRS Account Schwartz Laser Eye Center
Verification Date January 2013