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NCT Number: NCT01272089

A 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.

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Key information

Conditions

Allergic Conjunctivitis Conjunctival Diseases Conjunctivitis Conjunctivitis, Allergic Eye Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Kolkata, 700020, India

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Olopatadine Hydrochloride Ophthalmic Solution, 0.2%

Drug

Olopatadine Hydrochloride Ophthalmic Solution, 0.2%, one drop once a day for one week

Other names: Pataday

Primary outcomes

  1. Overall Patient Satisfaction

    Time frame: Day 7

    As assessed by the subject on a questionnaire

Sponsors and collaborators

Lead sponsor

Alcon Research

Industry

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Jan 7, 2011
Registry last updated
Sep 18, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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