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Ketotifen/Naphazoline Ophthalmic Solution in the Conjunctival Allergen Challenge Model of Acute Allergic Conjunctivitis.

NCT ID: NCT00770133

Last Updated: 2020-10-27

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

PHASE3

Total Enrollment

141 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-02-28

Study Completion Date

2010-06-30

Brief Summary

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The purpose of this study is to establish the safety and efficacy of ketotifen/naphazoline ophthalmic solution compared to vehicle and its individual components in alleviating the signs and symptoms of conjunctival allergen challenge (CAC)-induced 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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Ketotifen/naphazoline

Ketotifen/naphazoline ophthalmic solution administered in either the right eye, left eye or both eyes at visit 3 and visit 4.

Group Type EXPERIMENTAL

Ketotifen/naphazoline

Intervention Type DRUG

One drop of ketotifen fumarate 0.025% and naphazoline HCl 0.05% ophthalmic solution at visit 3 and visit 4.

Vehicle

Vehicle of ketotifen/naphazoline ophthalmic solution administered in either the right eye, left eye or both eyes at visit 3 and visit 4.

Group Type PLACEBO_COMPARATOR

Vehicle

Intervention Type DRUG

One drop of vehicle ophthalmic solution at visit 3 and visit 4.

Naphazoline

Naphazoline ophthalmic solution administered in either the right eye, left eye or both eyes at visit 3 and visit 4.

Group Type ACTIVE_COMPARATOR

Naphazoline

Intervention Type DRUG

One drop of naphazoline HCl 0.05% ophthalmic solution at visits 3 and 4.

Ketotifen

Ketotifen ophthalmic solution administered in either the right eye, left eye or both eyes at visit 3 and visit 4.

Group Type ACTIVE_COMPARATOR

Ketotifen

Intervention Type DRUG

One drop of ketotifen fumarate 0.025% ophthalmic solution at visits 3 and 4.

Interventions

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Ketotifen/naphazoline

One drop of ketotifen fumarate 0.025% and naphazoline HCl 0.05% ophthalmic solution at visit 3 and visit 4.

Intervention Type DRUG

Naphazoline

One drop of naphazoline HCl 0.05% ophthalmic solution at visits 3 and 4.

Intervention Type DRUG

Ketotifen

One drop of ketotifen fumarate 0.025% ophthalmic solution at visits 3 and 4.

Intervention Type DRUG

Vehicle

One drop of vehicle ophthalmic solution at visit 3 and visit 4.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Positive history of ocular allergies and positive skin test reaction to cat hair, cat dander, grasses, ragweed, and/or trees within the past 24 months.
* Calculated best-corrected visual acuity of 0.7 logMAR or better in each eye as measured using the ETDRS chart.
* Positive bilateral conjunctival allergen challenge(CAC) reaction within 10 minutes of instillation of the last titration of allergen at visit 1.
* Positive bilateral CAC reaction for at least 2 out of 3 time points at visit 2.

Exclusion Criteria

* Known contraindications or sensitivities to the study medication or its components.
* Any ocular condition that, in the opinion of the investigator, could affect the subjects safety or trial parameters.
* Use of disallowed medications during the period indicated prior to study enrollment or during the study.
Minimum Eligible Age

6 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bausch & Lomb Incorporated

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Laura Trusso

Role: STUDY_DIRECTOR

Bausch & Lomb Incorporated

Locations

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Ophthalmic Research Consultants, Inc.

North Andover, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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572

Identifier Type: -

Identifier Source: org_study_id