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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier:
NCT00769886
First received: October 8, 2008
Last updated: November 22, 2013
Last verified: November 2013
  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 3

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:


Further study details as provided by Bausch & Lomb Incorporated:

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 Incorporated
  More Information

No publications provided

Responsible Party: Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier: NCT00769886     History of Changes
Other Study ID Numbers: 571
Study First Received: October 8, 2008
Last Updated: November 22, 2013
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
Ophthalmic Solutions
Ketotifen
Naphazoline
Pharmaceutical Solutions
Therapeutic Uses
Pharmacologic Actions
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
Cardiovascular Agents
Respiratory System Agents

ClinicalTrials.gov processed this record on August 26, 2014