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A Comparison of Olopatadine and Fluticasone in Patients With Allergic Conjunctivitis

This study has been completed.
Sponsor:
Information provided by:
Greiner, Jack V., OD DO PhD
ClinicalTrials.gov Identifier:
NCT00655109
First received: April 2, 2008
Last updated: NA
Last verified: April 2008
History: No changes posted
  Purpose

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 Intervention Phase
Conjunctivitis, Allergic
 Drug: Olopatadine
Drug: Fluticasone
Drug: Saline
Drug: Artificial tears
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:

MedlinePlus related topics: Pinkeye
U.S. FDA Resources

Further study details as provided by Greiner, Jack V., OD DO PhD:

Primary Outcome Measures:
  • Ocular itching [ Time Frame: Minutes following CAC ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Ocular redness [ Time Frame: Minutes following CAC ] [ Designated as safety issue: No ]

Enrollment: 60
Study Start Date: February 2008
Study Completion Date: March 2008
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: April 2, 2008
Last Updated: April 2, 2008
Health Authority: United States: Institutional Review Board

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
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
 Respiratory System Agents
Therapeutic Uses
Dermatologic Agents
Anti-Allergic Agents
Anti-Inflammatory Agents
Histamine H1 Antagonists, Non-Sedating
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents

ClinicalTrials.gov processed this record on May 23, 2013