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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Bausch & Lomb Incorporated

ClinicalTrials.gov Identifier:

NCT00770133

First received: October 8, 2008

Last updated: December 7, 2011

Last verified: December 2011

History of Changes

Tracking Information

First Received Date ^ICMJE

October 8, 2008

Last Updated Date

December 7, 2011

Start Date ^ICMJE

February 2010

Primary Completion Date

April 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Ocular itching [ Time Frame: 3, 5 and 7 minutes post-challenge ] [ Designated as safety issue: No ]
Conjunctival redness [ Time Frame: 7, 15 and 20 minutes post-challenge ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00770133 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Ciliary and episcleral redness, chemosis, lid swelling, tearing and ocular mucus discharge. [ Time Frame: 7, 15 and 20 minutes post challenge ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

A Multi-center, Double-masked, Randomized, Placebo-controlled Evaluation of the Onset and Duration of Action of KetoNaph Ophthalmic Solution in the Conjunctival Allergen Challenge (CAC) Model of Acute Allergic Conjunctivitis.

Brief Summary

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

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment

Condition ^ICMJE

Allergic Conjunctivitis

Intervention ^ICMJE

Drug: Ketotifen/naphazoline
One drop of ketotifen fumarate 0.025% and naphazoline HCl 0.05% ophthalmic solution at visit 3 and visit 4.
Drug: Naphazoline
One drop of naphazoline HCl 0.05% ophthalmic solution at visits 3 and 4.
Drug: Ketotifen
One drop of ketotifen fumarate 0.025% ophthalmic solution at visits 3 and 4.
Drug: Vehicle
One drop of vehicle ophthalmic solution at visit 3 and visit 4.

Study Arm (s)

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

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

Intervention: Drug: Vehicle
Active Comparator: Naphazoline
Naphazoline ophthalmic solution administered in either the right eye, left eye or both eyes at visit 3 and visit 4.

Intervention: Drug: Naphazoline
Active Comparator: Ketotifen
Ketotifen ophthalmic solution administered in either the right eye, left eye or both eyes at visit 3 and visit 4.

Intervention: Drug: Ketotifen

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

133

Completion Date

June 2010

Primary Completion Date

April 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

6 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00770133

Other Study ID Numbers ^ICMJE

572

Has Data Monitoring Committee

Responsible Party

Bausch & Lomb Incorporated

Study Sponsor ^ICMJE

Bausch & Lomb Incorporated

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Laura Trusso

Bausch & Lomb Incorporated

Information Provided By

Bausch & Lomb Incorporated

Verification Date

December 2011

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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