Patient Preference Study

Verified by: Alcon Research, March 2008
First Received: December 17, 2007 | Last Updated: March 24, 2008 | Phase: Phase 3 | Start Date: November 2007
Overall Status: Completed | Estimated Enrollment: 115
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Patients will receive a single drop of two test articles and assess their...

Brief Summary

Official Title: “A Single Dose Patient Preference Study Comparison in Patients With Open-Angle Glaucoma or Ocular Hypertension”

Patients will receive a single drop of two test articles and assess their comfort

  • Study Type: Interventional
  • Study Design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
  • Study Primary Completion Date: March 2008

Intervention(s) in this Clinical Trial

  • Drug: AL-3862 + Timolol
    • Dosage of drug
  • Drug: Timolol
    • Timolol drops as needed

Arms, Groups and Cohorts in this Clinical Trial

  • Active Comparator: 1
  • Experimental: 2

Outcome Measures for this Clinical Trial

Primary Measures

  • Patient Preference
    • Time Frame: 2 min
      Safety Issue?: No

Secondary Measures

  • Comfort/discomfort of medication after dosing with one drop
    • Time Frame: 2
      Safety Issue?: No

Criteria for Participation in this Clinical Trial

Inclusion Criteria:

  • Glaucoma or ocular hypertension
  • No corticosteroid use within 30 days
  • No antihistamine or analgesic drug use
  • No artificial tear use within 3 days
  • No concurrent conjunctivitis, keratitis, scleritis or uveitis

Exclusion Criteria:

  • History of bronchial asthma or severe chronic obstructive pulmonary disease

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Clinical Trial Investigator Information

Lead Investigator: Alcon Research Industry

Additional Information

Information obtained from ClinicalTrials.gov on February 09, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00576342

Study ID Number: C-07-47

ClinicalTrials.gov Identifier: NCT00576342

Health Authority: United States: Food and Drug Administration

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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00576342