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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

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

Page last updated: August 23, 2015

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