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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01272089
Recruitment Status : Completed
First Posted : January 7, 2011
Last Update Posted : September 18, 2012
Sponsor:
Information provided by (Responsible Party):
Alcon Research

Tracking Information
First Submitted Date  ICMJE January 5, 2011
First Posted Date  ICMJE January 7, 2011
Last Update Posted Date September 18, 2012
Study Start Date  ICMJE May 2011
Actual 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 ]
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) ]
  • Quality of Life Questionnaire [ Time Frame: Visit 2 (Day 7) ]
    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 Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures 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  ICMJE Phase 4
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (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 Arms  ICMJE 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
Actual Enrollment  ICMJE
 (submitted: November 17, 2011)
300
Original Estimated Enrollment  ICMJE
 (submitted: January 6, 2011)
200
Actual Study Completion Date  ICMJE December 2011
Actual 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE India
Removed Location Countries United States
 
Administrative Information
NCT Number  ICMJE NCT01272089
Other Study ID Numbers  ICMJE C-11-013
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Alcon Research
Study Sponsor  ICMJE Alcon Research
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Alcon Research
Verification Date September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP