A Comparison of Olopatadine and Fluticasone in Patients W... | NCT00655109

Studies
A Comparison of Olopatadine and Fluticasone in Patients With Allergic Conjunctivitis

NCT00655109

Sponsor

Greiner, Jack V., OD DO PhD

Status

Completed

Last Update Posted

Apr 9, 2008Estimated

Enrollment

60Actual

Phase

Phase 4

Conditions

Conjunctivitis, Allergic

Interventions

Olopatadine
Fluticasone
Saline
Artificial tears

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

Apr 2008

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

Feb 2008

Primary Completion Date

Mar 2008Actual

Completion Date

Mar 2008Actual

First Submitted Date

Apr 2, 2008

First Submission Date that Met QC Criteria

Apr 2, 2008

First Posted Date

Apr 9, 2008Estimated

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

Apr 2, 2008

Last Update Posted Date

Apr 9, 2008Estimated

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

Description Module

Brief Summary

To compare the clinical efficacy of olopatadine and fluticasone in a 3-week single center, double-masked, randomized, placebo controlled parallel treatment conjunctival allergen challenge (CAC) study in patients with allergic conjunctivitis

Detailed Description

Study will evaluate the efficacy of nasal anti-allergic therapy compared to ocular anti-allergic therapy in the prevention of ocular allergic symptoms.

Design Module

Study Type

Interventional

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

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Active Comparator	Olopatadine	Drug: Olopatadine
2	Active Comparator	Fluticasone	Drug: Fluticasone
3	Placebo Comparator	Placebo nasal spray	Drug: Saline
4	Placebo Comparator	Placebo Eyedrops	Drug: Artificial tears

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Olopatadine	Drug	Ophthalmic solution	1
Fluticasone

Measure	Description	Time Frame
Ocular itching		Minutes following CAC

Measure	Description	Time Frame
Ocular redness		Minutes following CAC

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

At least 18 years of age & either sex, any race
Willing and able to follow all instructions and attend all study visits
Positive history of ocular allergies
Reproducible positive ocular allergic reaction induced by conjunctival allergen challenge

Exclusion Criteria:

Have planned surgery during trial period
Female currently pregnant, planning a pregnancy, or lactating
Use of disallowed medications

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

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jack V Greiner, OD, DO, PhD	ORA, Inc.	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ophthalmic Research Associates, Inc		North Andover	Massachusetts	01845	United States

Condition Browse Module

MeSH Terms

ID	Term
D003233	Conjunctivitis, Allergic

Ancestor Terms

ID	Term
D003231	Conjunctivitis
D003229	Conjunctival Diseases
D005128	Eye Diseases
D006969	Hypersensitivity, Immediate

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000069605	Olopatadine Hydrochloride
D000068298	Fluticasone
D012965	Sodium Chloride
D065346	Lubricant Eye Drops

Ancestor Terms

ID	Term
D003990	Dibenzoxepins
D006575	Heterocyclic Compounds, 3-Ring
D000072471	Heterocyclic Compounds, Fused-Ring
D006571	Heterocyclic Compounds

Browse Leaves

Not provided

Browse Branches

Not provided