Official Title: “A Comparison of Olopatadine Versus Fluticasone Nasal Spray in the Prevention of the Signs and Symptoms of Allergic Conjunctivitis”

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

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Parallel Assignment, Efficacy Study

Study Primary Completion Date: March 2008

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

Intervention(s) in this Clinical Trial

• Drug: Olopatadine
  • Ophthalmic solution
• Drug: Fluticasone
  • Nasal spray
• Drug: Saline
  • Nasal spray
• Drug: Artificial tears
  • Ophthalmic Solution

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: 1
  • Olopatadine
• Active Comparator: 2
  • Fluticasone
• Placebo Comparator: 3
  • Placebo nasal spray
• Placebo Comparator: 4
  • Placebo Eyedrops

Primary Measures

• Ocular itching
  • Time Frame: Minutes following CAC
    Safety Issue?: No

Secondary Measures

• Ocular redness
  • Time Frame: Minutes following CAC
    Safety Issue?: No

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Greiner, Jack V., OD DO PhD

Overall Clinical Trial Officials and Contacts

Jack V Greiner, OD, DO, PhD Principal Investigator Ophthalmic Research Associates  

Information obtained from ClinicalTrials.gov on November 20, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00655109

Study ID Number: 08-003-04

ClinicalTrials.gov Identifier: NCT00655109

Health Authority: United States: Institutional Review Board