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

Sponsored by:	Bausch & Lomb, Inc.
Information provided by:	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: Ketotifen/naphazoline and Vehicle Drug: Ketotifen/naphazoline and Naphazoline Drug: Ketotifen/naphazoline and Ketotifen Drug: Ketotifen and Ketotifen/naphazoline Drug: Ketotifen and Vehicle Drug: Ketotifen and Naphazoline Drug: Ketotifen Drug: Naphazoline and Ketotifen/naphazoline Drug: Naphazoline and Vehicle Drug: Naphazoline Drug: Naphazoline and Ketotifen Drug: Vehicle and Ketotifen/naphazoline Drug: Vehicle Drug: Vehicle and Naphazoline Drug: Vehicle and Ketotifen	Phase III

Drug Information available for: Phenylephrine Guaifenesin Naphazoline Naphazoline hydrochloride Oxymetazoline Oxymetazoline hydrochloride Phenylephrine hydrochloride Phenylpropanolamine Phenylpropanolamine hydrochloride Ketotifen Ketotifen fumarate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study

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 ]

Estimated Enrollment:	144
Study Start Date:	January 2009
Estimated Study Completion Date:	March 2009
Estimated Primary Completion Date:	March 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator Right eye - Ketotifen/naphazoline, left eye - Ketotifen/naphazoline	Drug: Ketotifen/naphazoline One drop of ketotifen/naphazoline in right eye; one drop of ketotifen/naphazoline in left eye at visit 3 and visit 4.
2: Active Comparator Right eye - Ketotifen/naphazoline, left eye - Vehicle	Drug: Ketotifen/naphazoline and Vehicle One drop of ketotifen/naphazoline in right eye; one drop of vehicle in left eye at visit 3 and visit 4.
3: Active Comparator Right eye - Ketotifen/naphazoline, left eye - naphazoline	Drug: Ketotifen/naphazoline and Naphazoline One drop of ketotifen/naphazoline in right eye; one drop of naphazoline in the left eye at visits 3 and 4.
4: Active Comparator Right eye - Ketotifen/naphazoline, left eye - ketotifen	Drug: Ketotifen/naphazoline and Ketotifen One drop of ketotifen/naphazoline in the right eye; one drop of ketotifen in the left eye at visits 3 and 4.
5: Active Comparator Right eye - ketotifen, left eye - Ketotifen/naphazoline	Drug: Ketotifen and Ketotifen/naphazoline One drop of ketotifen in the right eye; one drop of ketotifen/naphazoline in the left eye at visits 3 and 4.
6: Active Comparator Right eye - ketotifen, left eye - Vehicle	Drug: Ketotifen and Vehicle One drop of ketotifen in the right eye; one drop of vehicle in the left eye at visits 3 and 4.
7: Active Comparator Right eye - ketotifen, left eye - naphazoline	Drug: Ketotifen and Naphazoline One drop of Ketotifen in the right eye; and one drop of naphazoline in the left eye at visits 3 and 4.
8: Active Comparator Right eye - ketotifen, left eye - ketotifen	Drug: Ketotifen One drop of Ketotifen in right eye; one drop of Ketotifen in left eye at visit 3 and visit 4.
9: Active Comparator Right eye - naphazoline, left eye ketotifen/naphazoline	Drug: Naphazoline and Ketotifen/naphazoline One drop of naphazoline in the right eye and one drop of ketotifen/naphazoline in the left eye at visits 3 and 4.
10: Active Comparator Right eye - naphazoline, left eye - vehicle	Drug: Naphazoline and Vehicle One drop of naphazoline in the right eye and one drop of vehicle in the left eye at visits 3 and 4.
11: Active Comparator Right eye - naphazoline, left eye - naphazoline	Drug: Naphazoline One drop of naphazoline in right eye; one drop of naphazoline in left eye at visit 3 and visit 4.
12: Active Comparator Right eye - naphazoline, left eye - ketotifen	Drug: Naphazoline and Ketotifen One drop of naphazoline in right eye; one drop of Ketotifen in left eye at visit 3 and visit 4.
13: Active Comparator Right eye - vehicle, left eye - ketotifen/naphazoline	Drug: Vehicle and Ketotifen/naphazoline One drop of vehicle in right eye; one drop of ketotifen/naphazoline in left eye at visit 3 and visit 4.
14: Placebo Comparator Right eye - vehicle, left eye - vehicle	Drug: Vehicle One drop of vehicle in right eye; one drop of vehicle in left eye at visit 3 and visit 4.
15: Active Comparator Right eye - vehicle, left eye - naphazoline	Drug: Vehicle and Naphazoline One drop of vehicle in right eye; one drop of naphazoline in left eye at visit 3 and visit 4.
16: Active Comparator Right eye - vehicle, left eye ketotifen	Drug: Vehicle and Ketotifen One drop of vehicle in right eye; one drop of Ketotifen in left 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 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

Contacts

Contact: Jennifer Lynch

(585) 338-6230

jennifer.lynch@bausch.com

Locations

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

Sponsors and Collaborators

Bausch & Lomb, Inc.

More Information

Responsible Party:	Bausch & Lomb, Incorporated ( Marcia De Souza Lima, MD )
Study ID Numbers:	572
Study First Received:	October 8, 2008
Last Updated:	October 8, 2008
ClinicalTrials.gov Identifier:	NCT00770133
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Pseudoephedrine
Conjunctivitis, Allergic
Eye Diseases
Conjunctivitis
Conjunctival Diseases
Histamine
Naphazoline
Oxymetazoline

Hypersensitivity
Ketotifen
Phenylephrine
Guaifenesin
Hypersensitivity, Immediate
Histamine phosphate
Ephedrine
Phenylpropanolamine

Additional relevant MeSH terms:

Respiratory System Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Cardiotonic Agents
Physiological Effects of Drugs
Adrenergic Agonists
Nasal Decongestants
Therapeutic Uses
Vasoconstrictor Agents
Appetite Depressants
Antipruritics
Dermatologic Agents
Adrenergic alpha-Agonists
Immune System Diseases

Sympathomimetics
Histamine Agents
Anti-Allergic Agents
Cardiovascular Agents
Protective Agents
Pharmacologic Actions
Anti-Obesity Agents
Mydriatics
Histamine Antagonists
Autonomic Agents
Expectorants
Histamine H1 Antagonists
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 16, 2009