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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00769886
Recruitment Status : Completed
First Posted : October 9, 2008
Last Update Posted : December 17, 2013
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Allergic Conjunctivitis Drug: Ketotifen/naphazoline Drug: Ketotifen Drug: Naphazoline Drug: Vehicle Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 144 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : October 2008
Primary Completion Date : December 2008
Study Completion Date : June 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Care Pinkeye
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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.


Outcome Measures

Primary Outcome Measures :
  1. Ocular itching [ Time Frame: 3, 5 and 7 minutes post-challenge ]
  2. Conjunctival redness [ Time Frame: 7, 15 and 20 minutes post-challenge ]

Secondary Outcome Measures :
  1. Ciliary and episcleral redness, chemosis, lid swelling, tearing, ocular mucus drainage [ Time Frame: 7, 15 and 20 minutes post challenge ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00769886


Locations
United States, Massachusetts
Ophthalmic Research Consultants, Inc.
North Andover, Massachusetts, United States, 01845
Sponsors and Collaborators
Bausch & Lomb Incorporated
More Information

Responsible Party: Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier: NCT00769886     History of Changes
Other Study ID Numbers: 571
First Posted: October 9, 2008    Key Record Dates
Last Update Posted: December 17, 2013
Last Verified: November 2013

Additional relevant MeSH terms:
Conjunctivitis
Conjunctivitis, Allergic
Conjunctival Diseases
Eye Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Pharmaceutical Solutions
Ophthalmic Solutions
Ketotifen
Naphazoline
Antipruritics
Dermatologic Agents
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Allergic Agents
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Nasal Decongestants
Vasoconstrictor Agents
Respiratory System Agents