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:


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
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: 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
Ophthalmic Solutions
Fluticasone
Olopatadine
Pharmaceutical Solutions
Therapeutic Uses
Pharmacologic Actions
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
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Antirheumatic Agents
Histamine H1 Antagonists, Non-Sedating
Histamine H1 Antagonists
Histamine Antagonists

ClinicalTrials.gov processed this record on August 28, 2014