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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
History of Changes
  Purpose

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.


Condition Intervention Phase
Allergic Conjunctivitis
 Drug: Olopatadine Hydrochloride Ophthalmic Solution, 0.2%
 Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Pinkeye
U.S. FDA Resources

Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • Overall Patient Satisfaction [ Time Frame: Day 7 ] [ Designated as safety issue: No ]
    As assessed by the subject on a questionnaire


Enrollment: 300
Study Start Date: May 2011
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Pataday
Olopatadine Hydrochloride Ophthalmic Solution, 0.2%, one drop once daily for one week
 Drug: Olopatadine Hydrochloride Ophthalmic Solution, 0.2%
Olopatadine Hydrochloride Ophthalmic Solution, 0.2%, one drop once a day for one week
Other Name: Pataday

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01272089

Locations
India
Kolkata, India, 700020
Sponsors and Collaborators
Alcon Research
  More Information

No publications provided

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT01272089     History of Changes
Other Study ID Numbers: C-11-013
Study First Received: January 5, 2011
Last Updated: September 16, 2012
Health Authority: India: Institutional Review Board

Additional relevant MeSH terms:
Conjunctivitis
Conjunctivitis, Allergic
Conjunctival Diseases
Eye Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Olopatadine
Histamine H1 Antagonists, Non-Sedating
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
 Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Anti-Allergic Agents
Therapeutic Uses
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anti-Inflammatory Agents
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on June 17, 2013