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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Hypersensitivity, Immediate
Immune System Diseases
Olopatadine
Ophthalmic Solutions
Pharmaceutical Solutions
Analgesics
Analgesics, Non-Narcotic
Anti-Allergic Agents
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Antirheumatic Agents
Central Nervous System Agents
Histamine Agents
Histamine Antagonists
Histamine H1 Antagonists
Histamine H1 Antagonists, Non-Sedating
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 29, 2014