Study of Two Marketed Ocular Anti-Allergy Medications in Subjects With Allergic Conjunctivitis

NCT ID: NCT00534794

Last Updated: 2015-05-13

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

79 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-10-31

Brief Summary

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The purpose of this study is to compare the effects of two marked ocular anti-allergy medications in cat sensitive subjects with 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

Participants Investigators

Study Groups

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Elestat

Group Type EXPERIMENTAL

Elestat

Intervention Type DRUG

Elestat BID for 2 days

Pataday

Group Type ACTIVE_COMPARATOR

Pataday

Intervention Type DRUG

Pataday QD for 2 days

Interventions

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Elestat

Elestat BID for 2 days

Intervention Type DRUG

Pataday

Pataday QD for 2 days

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Documented history of ocular allergy to cats.
* Positive skin prick allergen reaction to cat dander.

Exclusion Criteria

* Use of any topical or systemic corticosteroids, immunosuppressive agents, antihistamines, decongestants, NSAIDs, or asprin during the two weeks prior to enrollment into the study.
* History of severe asthma, reactive airway disease or bronchial obstruction.
* Ocular surgery or trauma in the last year.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Michael Raizman, MD

Role: PRINCIPAL_INVESTIGATOR

Ophthalmic Consultants of Boston

Locations

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Ophthalmic Consultants of Boston

Boston, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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031-408

Identifier Type: -

Identifier Source: org_study_id

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