A Study of Patient Perception and Quality of Life Associated With the Use of Olopatadine 0.2% in Subjects With Allergic Conjunctivitis

Phase 4

Completed

• Conditions: Allergic Conjunctivitis
• Interventions: Drug: Olopatadine Hydrochloride Ophthalmic Solution, 0.2%

• Registration Number: NCT01272089
• Lead Sponsor: Alcon Research

Brief Summary

The purpose of this study was to evaluate subject perceptions of Olopatadine 0.2%, dosed once-daily, in subjects with allergic conjunctivitis and to record any adverse events as described by the subjects as a part of this post marketing surveillance study.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-01-05
• Study First Submitted QC: 2011-01-06
• Study First Posted: 2011-01-07
• Study Start: 2011-05
• Primary Completion: 2011-12
• Study Completion: 2011-12
• Status Verified: 2012-09
• Last Update Submitted: 2012-09-16
• Last Update Posted: 2012-09-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

• History (within the past 24 months) of allergic conjunctivitis.
• Willing to avoid contact lens wear for each of the study visits, immediately prior to study medication installation and for 10 minutes after installation of study drug.
• Contact lens wear should be stable and consistent for 3 months prior to Screening Visit (Day 1).
• Other protocol-defined inclusion criteria may apply.

Exclusion Criteria

• Contraindications or hypersensitivity to the use of the study medication or its components.
• Inability or unwillingness to follow all study instructions and complete study visits as required.
• Subjects with only one sighted eye or not correctable (using ETDRS chart) to 0.6 log MAR or better in both eyes at the Screening Visit.
• A known history of recurrent corneal erosion syndrome (idiopathic or secondary to dry eye).
• Ocular trauma within six months prior to Visit 1 in either eye as determined by subject history and/or examination.
• Other protocol-defined exclusion criteria may apply.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Pataday	Olopatadine Hydrochloride Ophthalmic Solution, 0.2%	Olopatadine Hydrochloride Ophthalmic Solution, 0.2%, one drop once daily for one week

Primary Outcome Measures

Name	Time	Method
Overall Patient Satisfaction	Day 7	As assessed by the subject on a questionnaire