A Comparison of Olopatadine and Fluticasone in Patients With Allergic Conjunctivitis

Conjunctivitis, Allergic Clinical Trial

Official title:

A Comparison of Olopatadine Versus Fluticasone Nasal Spray in the Prevention of the Signs and Symptoms of Allergic Conjunctivitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00655109
• Other study ID #: 08-003-04
• Status: Completed
• Phase: Phase 4
• First received: April 2, 2008
• Last updated: April 2, 2008
• Start date: February 2008
• Est. completion date: March 2008

Study information

• Verified date: April 2008
• Source: Greiner, Jack V., OD DO PhD
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: March 2008
• Est. primary completion date: March 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Conjunctivitis
• Conjunctivitis, Allergic

Intervention

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

Locations

Country	Name	City	State
United States	Ophthalmic Research Associates, Inc	North Andover	Massachusetts

Sponsors (1)

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

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ocular itching		Minutes following CAC	No
Secondary	Ocular redness		Minutes following CAC	No