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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Alcon Research

ClinicalTrials.gov Identifier:

NCT01272089

First received: January 5, 2011

Last updated: September 16, 2012

Last verified: September 2012

History of Changes

Tracking Information
First Received Date ^ICMJE	January 5, 2011
Last Updated Date	September 16, 2012
Start Date ^ICMJE	May 2011
Primary Completion Date	December 2011 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: September 16, 2012)	Overall Patient Satisfaction [ Time Frame: Day 7 ] [ Designated as safety issue: No ] As assessed by the subject on a questionnaire
Original Primary Outcome Measures ^ICMJE (submitted: January 6, 2011)	The primary statistical objective of this study is to describe the patient perception and quality of life. [ Time Frame: Visit 2 (Day 7) ] [ Designated as safety issue: Yes ] Quality of Life Questionnaire [ Time Frame: Visit 2 (Day 7) ] [ Designated as safety issue: No ] Questionnaires will be evaluated which includes a global investigator assessment, mini-RQLQ overall and 5 domain scores (for activity limitations, practical problems, nasal symptoms, eye symptoms, and non-nose/eye symptoms)
Change History	Complete list of historical versions of study NCT01272089 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	A Study of Patient Perception and Quality of Life Associated With the Use of Olopatadine 0.2% in Subjects With Allergic Conjunctivitis
Official Title ^ICMJE	A Multi-Site, Open-Label Study of Patient Perception and Quality of Life Associated With the Use of Olopatadine 0.2% in Subjects With Allergic Conjunctivitis
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 Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 4
Study Design ^ICMJE	Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Allergic Conjunctivitis
Intervention ^ICMJE	Drug: Olopatadine Hydrochloride Ophthalmic Solution, 0.2% Olopatadine Hydrochloride Ophthalmic Solution, 0.2%, one drop once a day for one week Other Name: Pataday
Study Arm (s)	Experimental: Pataday Olopatadine Hydrochloride Ophthalmic Solution, 0.2%, one drop once daily for one week Intervention: Drug: Olopatadine Hydrochloride Ophthalmic Solution, 0.2%
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	300
Completion Date	December 2011
Primary Completion Date	December 2011 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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.
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	India

Administrative Information
NCT Number ^ICMJE	NCT01272089
Other Study ID Numbers ^ICMJE	C-11-013
Has Data Monitoring Committee	No
Responsible Party	Alcon Research
Study Sponsor ^ICMJE	Alcon Research
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Alcon Research
Verification Date	September 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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