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A Comparison of Olopatadine and Fluticasone in Patients With Allergic Conjunctivitis

NCT ID: NCT00655109

Last Updated: 2008-04-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-02-29

Study Completion Date

2008-03-31

Brief Summary

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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

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

Conditions

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Conjunctivitis, Allergic

Keywords

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Allergic conjunctivitis Allergic rhinoconjunctivitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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1

Olopatadine

Group Type ACTIVE_COMPARATOR

Olopatadine

Intervention Type DRUG

Ophthalmic solution

2

Fluticasone

Group Type ACTIVE_COMPARATOR

Fluticasone

Intervention Type DRUG

Nasal spray

3

Placebo nasal spray

Group Type PLACEBO_COMPARATOR

Saline

Intervention Type DRUG

Nasal spray

4

Placebo Eyedrops

Group Type PLACEBO_COMPARATOR

Artificial tears

Intervention Type DRUG

Ophthalmic Solution

Interventions

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Olopatadine

Ophthalmic solution

Intervention Type DRUG

Fluticasone

Nasal spray

Intervention Type DRUG

Saline

Nasal spray

Intervention Type DRUG

Artificial tears

Ophthalmic Solution

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Greiner, Jack V., OD DO PhD

INDIV

Sponsor Role lead

Responsible Party

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Ophthalmic Research Associates

Principal Investigators

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Jack V Greiner, OD, DO, PhD

Role: PRINCIPAL_INVESTIGATOR

ORA, Inc.

Locations

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Ophthalmic Research Associates, Inc

North Andover, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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08-003-04

Identifier Type: -

Identifier Source: org_study_id