A Study of Patient Perception and Quality of Life Associated With the Use of Olopatadine 0.2% in Subjects With Allergic Conjunctivitis
Information source: Alcon Research
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Allergic Conjunctivitis
Intervention: Olopatadine Hydrochloride Ophthalmic Solution, 0.2% (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Alcon Research
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.
Clinical Details
Official title: 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
Study design: Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Overall Patient Satisfaction
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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.
Locations and Contacts
Kolkata 700020, India
Additional Information
Starting date: May 2011
Last updated: September 16, 2012
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