Evaluating Patients With Eye Allergies and Determining if... | NCT01679015

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

NCT01679015

Sponsor

Schwartz Laser Eye Center

Status

Completed

Last Update Posted

Jun 3, 2016Estimated

Enrollment

250Actual

Phase

Not provided

Conditions

Dry Eyes
Allergic Conjunctivitis

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2012

Primary Completion Date

Feb 2014Actual

Completion Date

Feb 2014Actual

First Submitted Date

Aug 20, 2012

First Submission Date that Met QC Criteria

Aug 30, 2012

First Posted Date

Sep 5, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 2, 2016

Last Update Posted Date

Jun 3, 2016Estimated

Name	Class
Allergan	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

250Actual

Label	Type	Description	Intervention Names
Dry Eyes, Eye Allergies		Patients with ocular allergies and those with dry eyes.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Prevalence of dry eye in an allergic population presenting to a high volume optometry practice		up to 2 years

Secondary Outcomes

Measure	Description	Time Frame
Prevalence of allergic patients with moderate to severe ocular signs and symptoms		up to 2 years

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients will be screened from existing patient database.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Marc R Bloomenstein, O.D.	Schwartz Laser Eye Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Schwartz Laser Eye Center		Scottsdale	Arizona	85260	United States

Condition Browse Module

MeSH Terms

ID	Term
D015352	Dry Eye Syndromes
D003233	Conjunctivitis, Allergic
D010292	Paresthesia
D011537	Pruritus

Ancestor Terms

ID	Term
D007766	Lacrimal Apparatus Diseases
D005128	Eye Diseases
D003231	Conjunctivitis
D003229	Conjunctival Diseases

Browse Leaves

Not provided

Browse Branches

Not provided