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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

144 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-10-31

Study Completion Date

2009-06-30

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.

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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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KetoNaph

KetoNaph (ketotifen fumarate 0.025%, naphazoline HCl 0.05%) ophthalmic solution

Group Type EXPERIMENTAL

Ketotifen/naphazoline

Intervention Type DRUG

One drop of ketotifen/naphazoline in study eye at visit 3 and visit 4.

Naphazoline

Naphazoline HCl 0.05% ophthalmic solution

Group Type ACTIVE_COMPARATOR

Naphazoline

Intervention Type DRUG

One drop of naphazoline in study eye at vist 3 and visit 4.

Ketotifen

Ketotifen fumarate 0.025% ophthalmic solution

Group Type ACTIVE_COMPARATOR

Ketotifen

Intervention Type DRUG

One drop of Ketotifen in study eye at visit 3 and visit 4.

Vehicle

Vehicle of KetoNaph ophthalmic solution

Group Type PLACEBO_COMPARATOR

Vehicle

Intervention Type DRUG

One drop of vehicle in study eye at visit 3 and visit 4.

Interventions

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Ketotifen/naphazoline

One drop of ketotifen/naphazoline in study eye at visit 3 and visit 4.

Intervention Type DRUG

Ketotifen

One drop of Ketotifen in study eye at visit 3 and visit 4.

Intervention Type DRUG

Naphazoline

One drop of naphazoline in study eye at vist 3 and visit 4.

Intervention Type DRUG

Vehicle

One drop of vehicle in study eye 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 in 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