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Patient Preference Study

This study has been completed.
Sponsor:
Information provided by:
Alcon Research
ClinicalTrials.gov Identifier:
NCT00576342
First received: December 17, 2007
Last updated: March 24, 2008
Last verified: March 2008
History of Changes
  Purpose

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


Condition Intervention Phase
Glaucoma
Ocular Hypertension
 Drug: AL-3862 + Timolol
Drug: Timolol
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: A Single Dose Patient Preference Study Comparison in Patients With Open-Angle Glaucoma or Ocular Hypertension

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • Patient Preference [ Time Frame: 2 min ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Comfort/discomfort of medication after dosing with one drop [ Time Frame: 2 ] [ Designated as safety issue: No ]

Estimated Enrollment: 115
Study Start Date: November 2007
Study Completion Date: March 2008
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1 Drug: AL-3862 + Timolol
Dosage of drug
Experimental: 2 Drug: Timolol
Timolol drops as needed

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00576342

Locations
United States, Tennessee
Maryville
Maryville, Tennessee, United States, 37803
Sponsors and Collaborators
Alcon Research
  More Information

No publications provided

Responsible Party: Terry Wiernas, Alcon Research Ltd.
ClinicalTrials.gov Identifier: NCT00576342     History of Changes
Other Study ID Numbers: C-07-47
Study First Received: December 17, 2007
Last Updated: March 24, 2008
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Glaucoma
Hypertension
Ocular Hypertension
Eye Diseases
Vascular Diseases
Cardiovascular Diseases
Timolol
Adrenergic beta-Antagonists
Adrenergic Antagonists
 Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses
Antihypertensive Agents

ClinicalTrials.gov processed this record on May 19, 2013