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A Comparison of Olopatadine and Fluticasone in Patients With 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: NCT00655109
Recruitment Status : Completed
First Posted : April 9, 2008
Last Update Posted : April 9, 2008
Sponsor:
Information provided by:

Study Description
Brief Summary:
To compare the clinical efficacy of olopatadine and fluticasone in a 3-week single center, double-masked, randomized, placebo controlled parallel treatment conjunctival allergen challenge (CAC) study in patients with allergic conjunctivitis

Condition or disease Intervention/treatment Phase
Conjunctivitis, Allergic Drug: Olopatadine Drug: Fluticasone Drug: Saline Drug: Artificial tears Phase 4

Detailed Description:
Study will evaluate the efficacy of nasal anti-allergic therapy compared to ocular anti-allergic therapy in the prevention of ocular allergic symptoms.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Comparison of Olopatadine Versus Fluticasone Nasal Spray in the Prevention of the Signs and Symptoms of Allergic Conjunctivitis
Study Start Date : February 2008
Primary Completion Date : March 2008
Study Completion Date : March 2008

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
Active Comparator: 1
Olopatadine
Drug: Olopatadine
Ophthalmic solution
Active Comparator: 2
Fluticasone
Drug: Fluticasone
Nasal spray
Placebo Comparator: 3
Placebo nasal spray
Drug: Saline
Nasal spray
Placebo Comparator: 4
Placebo Eyedrops
Drug: Artificial tears
Ophthalmic Solution


Outcome Measures

Primary Outcome Measures :
  1. Ocular itching [ Time Frame: Minutes following CAC ]

Secondary Outcome Measures :
  1. Ocular redness [ Time Frame: Minutes following CAC ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • At least 18 years of age & either sex, any race
  • Willing and able to follow all instructions and attend all study visits
  • Positive history of ocular allergies
  • Reproducible positive ocular allergic reaction induced by conjunctival allergen challenge

Exclusion Criteria:

  • Have planned surgery during trial period
  • Female currently pregnant, planning a pregnancy, or lactating
  • Use of disallowed medications
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): NCT00655109


Locations
United States, Massachusetts
Ophthalmic Research Associates, Inc
North Andover, Massachusetts, United States, 01845
Sponsors and Collaborators
Greiner, Jack V., OD DO PhD
Investigators
Principal Investigator: Jack V Greiner, OD, DO, PhD ORA, Inc.
More Information

Responsible Party: Jack V. Greiner, OD DO PhD, Ophthalmic Research Associates
ClinicalTrials.gov Identifier: NCT00655109     History of Changes
Other Study ID Numbers: 08-003-04
First Posted: April 9, 2008    Key Record Dates
Last Update Posted: April 9, 2008
Last Verified: April 2008

Keywords provided by Greiner, Jack V., OD DO PhD:
Allergic conjunctivitis
Allergic rhinoconjunctivitis

Additional relevant MeSH terms:
Conjunctivitis
Conjunctivitis, Allergic
Conjunctival Diseases
Eye Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Fluticasone
Olopatadine Hydrochloride
Ophthalmic Solutions
Lubricant Eye Drops
Anti-Inflammatory Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Dermatologic Agents
Anti-Allergic Agents
Pharmaceutical Solutions
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Antirheumatic Agents
Histamine H1 Antagonists, Non-Sedating
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents