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
1 other identifier
interventional
300
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started May 2011
Shorter than P25 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 5, 2011
CompletedFirst Posted
Study publicly available on registry
January 7, 2011
CompletedStudy Start
First participant enrolled
May 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2011
CompletedSeptember 18, 2012
September 1, 2012
7 months
January 5, 2011
September 16, 2012
Conditions
Outcome Measures
Primary Outcomes (1)
Overall Patient Satisfaction
As assessed by the subject on a questionnaire
Day 7
Study Arms (1)
Pataday
EXPERIMENTALOlopatadine Hydrochloride Ophthalmic Solution, 0.2%, one drop once daily for one week
Interventions
Olopatadine Hydrochloride Ophthalmic Solution, 0.2%, one drop once a day for one week
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Alcon Researchlead
Study Sites (1)
Unknown Facility
Kolkata, 700020, India
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 5, 2011
First Posted
January 7, 2011
Study Start
May 1, 2011
Primary Completion
December 1, 2011
Study Completion
December 1, 2011
Last Updated
September 18, 2012
Record last verified: 2012-09