An Open-Label, Long-Term Study With AL-4943A Ophthalmic Solution, 0.2% in Patients With Allergic Conjunctivitis

NCT ID: NCT01037179

Last Updated: 2014-08-04

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

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-02-28

Study Completion Date

2010-05-31

Brief Summary

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The objective of this study is to assess safety and efficacy of long-term use of AL-4943A (Olopatadine Hydrochloride Ophthalmic Solution, 0.2%) in patients with allergic conjunctivitis.

Detailed Description

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Conditions

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Allergic Conjunctivitis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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AL-4943A

Olopatadine Hydrochloride Ophthalmic Solution, 0.2%, 2 drops instilled in each eye twice daily for 10 weeks

Group Type EXPERIMENTAL

Olopatadine Hydrochloride Ophthalmic Solution, 0.2%

Intervention Type DRUG

Interventions

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Olopatadine Hydrochloride Ophthalmic Solution, 0.2%

Intervention Type DRUG

Other Intervention Names

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PATADAY®

Eligibility Criteria

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Inclusion Criteria

* Subjects must provide written consent.
* Subjects must have a diagnosis of allergic conjunctivitis.

Exclusion Criteria

* Itching and/or hyperemia associated with diseases other than allergic conjunctivitis.
* Retinal detachment, diabetic retinopathy, or any progressive disease in posterior segment of the eye.
* Known history of ocular infection.
* Contact lens wear during study.
* Pregnant, nursing.
* Participation in another clinical study within 30 days of Informed Consent.
Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Alcon Research

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Investigational Center

Osaka, Osaka, Japan

Site Status

Countries

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Japan

Other Identifiers

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C-09-050

Identifier Type: -

Identifier Source: org_study_id

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