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

NCT ID: NCT01159769

Last Updated: 2012-04-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 215 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-06-30
• Study Completion Date: 2010-08-31

Brief Summary

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.

Conditions

Allergic Conjunctivitis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Olopatadine 0.2%

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

Group Type: EXPERIMENTAL

Olopatadine hydrochloride ophthalmic solution, 0.2% (Pataday®)

Intervention Type: DRUG

Commercially marketed ophthalmic solution for the treatment of ocular itching associated with allergic conjunctivitis

Interventions

Olopatadine hydrochloride ophthalmic solution, 0.2% (Pataday®)

Commercially marketed ophthalmic solution for the treatment of ocular itching associated with allergic conjunctivitis

Intervention Type: DRUG

Other Intervention Names

Pataday®

Eligibility Criteria

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.

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.

• Minimum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Alcon Research

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

SMA-10-13

Identifier Type: -

Identifier Source: org_study_id