Safety Study of Olopatadine Nasal Spray

Alcon

Status and phase: Completed; Phase 3

Conditions: Perennial Allergic Rhinitis

Treatments: Drug: Olopatadine 0.6% nasal spray; Drug: Placebo Nasal Spray

Study type: Interventional

Funder types: Industry

Identifiers

NCT00578331

C-05-69

Details and patient eligibility

About

The purpose of this study is to determine whether olopatadine nasal spray is safe and effective when used for up to one year by patients with perennial allergic rhinitis.

Enrollment: 890 patients

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with confirmed diagnosis of perennial allergic rhinitis who are 12 years and older

Exclusion criteria

• Age 11 years and younger

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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890 participants in 2 patient groups, including a placebo group

Olopatadine 0.6% Nasal Spray

Experimental group

Description:

2 sprays each nostril twice daily

Treatment:

Drug: Olopatadine 0.6% nasal spray

Placebo Nasal Spray

Placebo Comparator group

Description:

2 sprays each nostril twice daily

Treatment:

Drug: Placebo Nasal Spray