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

Sponsor:	Bausch & Lomb, Inc.
Information provided by (Responsible Party):	Bausch & Lomb, Inc.
ClinicalTrials.gov Identifier:	NCT00769886

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: Ketotifen Drug: Naphazoline 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, Vehicle and Active Controlled Evaluation of the Onset and Duration of Action of KetoNaph Ophthalmic Solution in the Conjunctival Allergen Challenge 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, ocular mucus drainage [ Time Frame: 7, 15 and 20 minutes post challenge ] [ Designated as safety issue: No ]

Enrollment:	144
Study Start Date:	October 2008
Study Completion Date:	June 2009
Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: KetoNaph KetoNaph (ketotifen fumarate 0.025%, naphazoline HCl 0.05%) ophthalmic solution	Drug: Ketotifen/naphazoline One drop of ketotifen/naphazoline in study eye at visit 3 and visit 4.
Active Comparator: Naphazoline Naphazoline HCl 0.05% ophthalmic solution	Drug: Naphazoline One drop of naphazoline in study eye at vist 3 and visit 4.
Active Comparator: Ketotifen Ketotifen fumarate 0.025% ophthalmic solution	Drug: Ketotifen One drop of Ketotifen in study eye at visit 3 and visit 4.
Placebo Comparator: Vehicle Vehicle of KetoNaph ophthalmic solution	Drug: Vehicle One drop of vehicle in study eye at visit 3 and visit 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 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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00769886

Locations

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

Sponsors and Collaborators

Bausch & Lomb, Inc.

More Information

No publications provided

Responsible Party:	Bausch & Lomb, Inc.
ClinicalTrials.gov Identifier:	NCT00769886 History of Changes
Other Study ID Numbers:	571
Study First Received:	October 8, 2008
Last Updated:	December 7, 2011
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Conjunctivitis
Conjunctivitis, Allergic
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