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Evaluation of Efficacy of Ophthalmic Solution in Seasonal Allergic Conjunctivitis

NCT ID: NCT00364091

Last Updated: 2011-09-27

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

PHASE3

Total Enrollment

365 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-08-31

Brief Summary

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The purpose of this summary is to evaluate the efficacy and safety of R89674 0.025% ophthalmic solution compared with placebo or an active control in subjects with seasonal allergic conjunctivitis

Detailed Description

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Conditions

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Allergic Conjunctivitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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R89674 0.025% ophthalmic solution

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* history of positive diagnostic test for ragweed within the past 2 years;
* positive bilateral response to ragweed as induced by conjunctival allergen challenge

Exclusion Criteria

* ocular infection;
* history of retinal detachment, diabetic neuropathy, or any progressive retinal disease;
* moderate to severe asthma;
* dry eye syndrome;
* history of severe, unstable, or uncontrolled cardiovascular, pulmonary, hepatic, renal or autoimmune disease;
* pregnancy or lactation
Minimum Eligible Age

10 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Vistakon Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Reza Haque, MD

Role: STUDY_DIRECTOR

Vistakon Pharmaceuticals

Locations

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Louisville, Kentucky, United States

Site Status

North Andover, Massachusetts, United States

Site Status

Creve Coeur, Missouri, United States

Site Status

Charlotte, North Carolina, United States

Site Status

Philadelphia, Pennsylvania, United States

Site Status

Memphis, Tennessee, United States

Site Status

Countries

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United States

Other Identifiers

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06-003-09

Identifier Type: -

Identifier Source: org_study_id