A Comparison of Olopatadine and Fluticasone in Patients With Allergic Conjunctivitis

Greiner, Jack V., OD DO PhD

Status and phase: Completed; Phase 4

Conditions: Conjunctivitis, Allergic

Treatments: Drug: Fluticasone; Drug: Olopatadine; Drug: Artificial tears; Drug: Saline

Study type: Interventional

Identifiers

NCT00655109

08-003-04

Details and patient eligibility

About

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

Full description

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

Enrollment: 60 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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60 participants in 4 patient groups, including a placebo group

1

Active Comparator group

Description:

Olopatadine

Treatment:

Drug: Olopatadine

2

Active Comparator group

Description:

Fluticasone

Treatment:

Drug: Fluticasone

3

Placebo Comparator group

Description:

Placebo nasal spray

Treatment:

Drug: Saline

4

Placebo Comparator group

Description:

Placebo Eyedrops

Treatment:

Drug: Artificial tears