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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
  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:


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
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.

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
Hypersensitivity, Immediate
Immune System Diseases
Olopatadine
Ophthalmic 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
Pharmaceutical Solutions
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014