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Assessment of Alcon's Ocular Image Quantification System

NCT ID: NCT01282138

Last Updated: 2012-12-18

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

13 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-12-31

Study Completion Date

2011-03-31

Brief Summary

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The purpose of this study was to evaluate ocular responses with different allergen provocation methods.

Detailed Description

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Subjects demonstrating a successful allergen response to a common allergen received the first study treatment and used as instructed for 5 days, after which they entered the Environmental Exposure Chamber (EEC) for a 3-hour exposure to a known concentration of the allergen. After waiting at least 7 days, subjects received the second study treatment and used as instructed for 5 days, after which a 3-hour Conjunctival Allergen Provocation Test (CAPT) was performed with an escalating concentration of the allergen. Subjects dosed with study treatment approximately 15 minutes prior to each allergen provocation test.

Conditions

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Allergic Conjunctivitis

Keywords

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Allergic conjunctivitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Patanol

One drop twice daily in each eye for five days prior to allergen provocation testing, followed by an additional drop in each eye approximately 15 minutes prior to start of testing.

Group Type EXPERIMENTAL

Olopatadine hydrochloride, 0.1% ophthalmic solution (Patanol)

Intervention Type DRUG

One drop twice daily in each eye for 5 days, followed by an additional drop in each eye prior to allergen test.

Tears Naturale II

One drop twice daily in each eye for five days prior to allergen provocation testing, followed by an additional drop in each eye approximately 15 minutes prior to start of testing.

Group Type PLACEBO_COMPARATOR

Dextran 70 0.1%, hydroxypropyl methylcellulose 0.3% (Tears Naturale II)

Intervention Type OTHER

One drop twice daily in each eye for 5 days, followed by an additional drop in each eye prior to allergen test.

Interventions

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Olopatadine hydrochloride, 0.1% ophthalmic solution (Patanol)

One drop twice daily in each eye for 5 days, followed by an additional drop in each eye prior to allergen test.

Intervention Type DRUG

Dextran 70 0.1%, hydroxypropyl methylcellulose 0.3% (Tears Naturale II)

One drop twice daily in each eye for 5 days, followed by an additional drop in each eye prior to allergen test.

Intervention Type OTHER

Other Intervention Names

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Patanol® Tears Naturale II

Eligibility Criteria

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Inclusion Criteria

* History of allergic conjunctivitis;
* Active signs and symptoms of ocular allergies;

Exclusion Criteria

* History of dry eye;
* Presence of ocular infection;
* Presence of severe or serious ocular conditions;
* Symptoms of allergic conjunctivitis;
* Use of topical or systemic ocular medications as specified in protocol;
* Ocular surgery or laser surgery within 6 months of study start;
* Unwilling to discontinue contact lens wear 72 hours prior to Visit 1 and during study period;
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 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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Contact Alcon Call Center for Trial Locations

Fort Worth, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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RDG-10-278

Identifier Type: -

Identifier Source: org_study_id