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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

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

January 5, 2011
September 16, 2012
May 2011
December 2011   (final data collection date for primary outcome measure)
Overall Patient Satisfaction [ Time Frame: Day 7 ] [ Designated as safety issue: No ]
As assessed by the subject on a questionnaire
  • 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)
Complete list of historical versions of study NCT01272089 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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Not Provided
 
A Study of Patient Perception and Quality of Life Associated With the Use of Olopatadine 0.2% in Subjects With Allergic Conjunctivitis
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

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.

Not Provided
Interventional
Phase 4
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Allergic Conjunctivitis
Drug: Olopatadine Hydrochloride Ophthalmic Solution, 0.2%
Olopatadine Hydrochloride Ophthalmic Solution, 0.2%, one drop once a day for one week
Other Name: Pataday
Experimental: Pataday
Olopatadine Hydrochloride Ophthalmic Solution, 0.2%, one drop once daily for one week
Intervention: Drug: Olopatadine Hydrochloride Ophthalmic Solution, 0.2%
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
300
December 2011
December 2011   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
India
 
NCT01272089
C-11-013
No
Alcon Research
Alcon Research
Not Provided
Not Provided
Alcon Research
September 2012

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