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

NCT01679015 | Completed

• 1 other identifier: AL-001
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

Brief Summary

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

Outcome Measures

Primary Outcomes (1)

• Prevalence of dry eye in an allergic population presenting to a high volume optometry practice

  up to 2 years

Secondary Outcomes (1)

• Prevalence of allergic patients with moderate to severe ocular signs and symptoms

  up to 2 years

Study Arms (1)

Dry Eyes, Eye Allergies

Patients with ocular allergies and those with dry eyes.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients will be screened from existing patient database.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Schwartz Laser Eye Center: lead
• Allergan: collaborator

Study Sites (1)

Schwartz Laser Eye Center

Scottsdale, Arizona, 85260, United States

Location

MeSH Terms

Conditions

Dry Eye Syndromes; Conjunctivitis, Allergic; Paresthesia; Pruritus

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases; Conjunctivitis; Conjunctival Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Somatosensory Disorders; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Skin Diseases; Skin and Connective Tissue Diseases; Skin Manifestations

Study Officials

• Marc R Bloomenstein, O.D.

  Schwartz Laser Eye Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: O.D.

Study Record Dates

• First Submitted: August 20, 2012
• First Posted: September 5, 2012
• Study Start: August 1, 2012
• Primary Completion: February 1, 2014
• Study Completion: February 1, 2014
• Last Updated: June 3, 2016

Record last verified: 2013-01

Locations

US (1)