Patient Perceptions and Quality of Life Associated With the Use of Olapatadine 0.2% for the Treatment of Allergic Conjunctivitis

Alcon

Status and phase: Completed; Phase 4

Conditions: Allergic Conjunctivitis

Treatments: Drug: Olopatadine hydrochloride ophthalmic solution, 0.2% (Pataday®)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01159769

SMA-10-13

Details and patient eligibility

About

The purpose of this study is to evaluate patient perceptions of olopatadine 0.2% dosed once daily in patients previously treated with twice-daily, topical, ocular, anti-allergy medications.

Enrollment: 215 patients

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 12 years of age or older.
• History (within the past 24 months) of allergic conjunctivitis.
• Active signs and symptoms of ocular allergies.
• Ocular health within normal limits, as determined by the investigator or subinvestigator.
• Willing to avoid contact lens wear each study visit immediately prior to study medication instillation and for 10 minutes after instillation of study drug.
• Other protocol-defined inclusion criteria may apply.

Exclusion criteria

• Contraindications or hypersensitivity to study medication or its components.
• One sighted eye or not correctable to 0.6 logMAR or better in both eyes at the screening visit.
• Known history of recurrent corneal erosion syndrome.
• Ocular trauma or surgical intervention within 6 months prior to Visit 1.
• Participation in any other investigational study within 30 days before Visit 1.
• Pregnant or nursing.
• Other protocol-defined exclusion criteria may apply.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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215 participants in 1 patient group

Olopatadine 0.2%

Experimental group

Description:

1 drop self-administered in each eye once daily in the morning for 7 days

Treatment:

Drug: Olopatadine hydrochloride ophthalmic solution, 0.2% (Pataday®)