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

Phase 4

Completed

• Conditions: Allergic Conjunctivitis
• Interventions: Drug: Olopatadine hydrochloride ophthalmic solution, 0.2% (Pataday®)

• Registration Number: NCT01159769
• Lead Sponsor: Alcon Research

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-06
• Study First Submitted: 2010-07-08
• Study First Submitted QC: 2010-07-08
• Study First Posted: 2010-07-09
• Primary Completion: 2010-08
• Study Completion: 2010-08
• Status Verified: 2012-03
• Results First Submitted: 2012-03-05
• Results First Submitted QC: 2012-03-05
• Last Update Submitted: 2012-03-05
• Results First Posted: 2012-04-03
• Last Update Posted: 2012-04-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 215

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Olopatadine 0.2%	Olopatadine hydrochloride ophthalmic solution, 0.2% (Pataday®)	1 drop self-administered in each eye once daily in the morning for 7 days

Primary Outcome Measures

Name	Time	Method
Overall Patient Satisfaction	Day 7	Overall satisfaction was assessed by the patient on a questionnaire. The patient was instructed to select a single response to the statement, "Overall, how satisfied were you with olopatadine 0.2%?" A 5-point scale was used: very satisfied, satisfied, undecided, dissatisfied, very dissatisfied. Results are reported as the percentage of patients who responded, "very satisfied" or "satisfied."