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

Sponsor:	Bausch & Lomb, Inc.
Information provided by (Responsible Party):	Bausch & Lomb, Inc.
ClinicalTrials.gov Identifier:	NCT00770133

Purpose

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.

Condition	Intervention	Phase
Allergic Conjunctivitis	Drug: Ketotifen/naphazoline Drug: Naphazoline Drug: Ketotifen Drug: Vehicle	Phase III

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

Resource links provided by NLM:

MedlinePlus related topics: Pinkeye

Drug Information available for: Phenylpropanolamine Ketotifen Ketotifen fumarate Triaminic Guaifenesin Phenylpropanolamine hydrochloride Naphazoline hydrochloride Naphazoline

U.S. FDA Resources

Further study details as provided by Bausch & Lomb, Inc.:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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 ]

Enrollment:	133
Study Start Date:	February 2010
Study Completion Date:	June 2010
Primary Completion Date:	April 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Ketotifen/naphazoline Ketotifen/naphazoline ophthalmic solution administered in either the right eye, left eye or both eyes at visit 3 and visit 4.	Drug: Ketotifen/naphazoline One drop of ketotifen fumarate 0.025% and naphazoline HCl 0.05% ophthalmic solution at visit 3 and visit 4.
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.	Drug: Vehicle One drop of vehicle ophthalmic solution at visit 3 and visit 4.
Active Comparator: Naphazoline Naphazoline ophthalmic solution administered in either the right eye, left eye or both eyes at visit 3 and visit 4.	Drug: Naphazoline One drop of naphazoline HCl 0.05% ophthalmic solution at visits 3 and 4.
Active Comparator: Ketotifen Ketotifen ophthalmic solution administered in either the right eye, left eye or both eyes at visit 3 and visit 4.	Drug: Ketotifen One drop of ketotifen fumarate 0.025% ophthalmic solution at visits 3 and 4.

Eligibility

Ages Eligible for Study:	6 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00770133

Locations

United States, Massachusetts
Ophthalmic Research Consultants, Inc.
North Andover, Massachusetts, United States, 01845

Sponsors and Collaborators

Bausch & Lomb, Inc.

Investigators

Study Director:

Laura Trusso

Bausch & Lomb, Inc.

More Information

No publications provided

Responsible Party:	Bausch & Lomb, Inc.
ClinicalTrials.gov Identifier:	NCT00770133 History of Changes
Other Study ID Numbers:	572
Study First Received:	October 8, 2008
Last Updated:	December 7, 2011
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Conjunctivitis, Allergic
Conjunctivitis
Conjunctival Diseases
Eye Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Naphazoline
Phenylpropanolamine
Ketotifen
Guaifenesin
Chlorpheniramine, phenylpropanolamine drug combination
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents

Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Nasal Decongestants
Vasoconstrictor Agents
Cardiovascular Agents
Therapeutic Uses
Respiratory System Agents
Expectorants
Appetite Depressants
Anti-Obesity Agents
Central Nervous System Agents
Sympathomimetics
Autonomic Agents

ClinicalTrials.gov processed this record on February 09, 2012