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Patient Perceptions and Quality of Life Associated With the Use of Olapatadine 0.2% for the Treatment of Allergic Conjunctivitis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT01159769
First received: July 8, 2010
Last updated: March 5, 2012
Last verified: March 2012
History of Changes
  Purpose

The purpose of this study is to evaluate patient perceptions of olopatadine 0.2% dosed once daily in patients previously treated with twice-daily, topical, ocular, anti-allergy medications.


Condition Intervention Phase
Allergic Conjunctivitis
 Drug: Olopatadine hydrochloride ophthalmic solution, 0.2% (Pataday®)
 Phase 4

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

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 0 ] [ Designated as safety issue: No ]
    Overall satisfaction was assessed by the patient on a questionnaire. The patient was instructed to select a single response to the statement, "Overall, how satisfied are you with your current eye allergy medication?" A 5-point scale was used: very satisfied, satisfied, undecided, dissatisfied, very dissatisfied. Results are reported as the percentage of patients who responded, "very satisfied" or "satisfied."

  • Overall Patient Satisfaction [ Time Frame: Day 7 ] [ Designated as safety issue: No ]
    Overall satisfaction was assessed by the patient on a questionnaire. The patient was instructed to select a single response to the statement, "Overall, how satisfied were you with olopatadine 0.2%?" A 5-point scale was used: very satisfied, satisfied, undecided, dissatisfied, very dissatisfied. Results are reported as the percentage of patients who responded, "very satisfied" or "satisfied."


Enrollment: 215
Study Start Date: June 2010
Study Completion Date: August 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Olopatadine 0.2%
1 drop self-administered in each eye once daily in the morning for 7 days
 Drug: Olopatadine hydrochloride ophthalmic solution, 0.2% (Pataday®)
Commercially marketed ophthalmic solution for the treatment of ocular itching associated with allergic conjunctivitis
Other Name: Pataday®

  Eligibility

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 12 years of age or older.
  • History (within the past 24 months) of allergic conjunctivitis.
  • Active signs and symptoms of ocular allergies.
  • Ocular health within normal limits, as determined by the investigator or subinvestigator.
  • Willing to avoid contact lens wear each study visit immediately prior to study medication instillation and for 10 minutes after instillation of study drug.
  • Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

  • Contraindications or hypersensitivity to study medication or its components.
  • One sighted eye or not correctable to 0.6 logMAR or better in both eyes at the screening visit.
  • Known history of recurrent corneal erosion syndrome.
  • Ocular trauma or surgical intervention within 6 months prior to Visit 1.
  • Participation in any other investigational study within 30 days before Visit 1.
  • Pregnant or nursing.
  • Other protocol-defined exclusion criteria may apply.
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT01159769     History of Changes
Other Study ID Numbers: SMA-10-13
Study First Received: July 8, 2010
Results First Received: March 5, 2012
Last Updated: March 5, 2012
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by Alcon Research:
Allergic conjunctivitis

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 18, 2013