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Patient Preference Study

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ClinicalTrials.gov Identifier: NCT00576342
Recruitment Status : Completed
First Posted : December 19, 2007
Last Update Posted : July 11, 2014
Sponsor:
Information provided by (Responsible Party):
Alcon Research

Brief Summary:
In this randomized crossover study, patients will receive a single drop of two test articles and assess comfort.

Condition or disease Intervention/treatment Phase
Glaucoma Ocular Hypertension Drug: AL-3862+timolol ophthalmic suspension Drug: Dorzolamide+timolol ophthalmic solution Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 129 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Single Dose Patient Preference Study Comparison in Patients With Open-Angle Glaucoma or Ocular Hypertension
Study Start Date : December 2007
Actual Primary Completion Date : January 2008
Actual Study Completion Date : January 2008


Arm Intervention/treatment
AL-3862+timolol, then COSOPT
AL-3862+timolol ophthalmic suspension, 1 drop in both eyes, followed by dorzolamide+timolol ophthalmic solution,1 drop in both eyes, 1 day later.
Drug: AL-3862+timolol ophthalmic suspension Drug: Dorzolamide+timolol ophthalmic solution
Other Name: COSOPT
COSOPT, then AL-3862+timolol
Dorzolamide+timolol ophthalmic solution, 1 drop in both eyes, followed by AL-3862+timolol ophthalmic suspension, 1 drop in both eyes, 1 day later.
Drug: AL-3862+timolol ophthalmic suspension Drug: Dorzolamide+timolol ophthalmic solution
Other Name: COSOPT



Primary Outcome Measures :
  1. Percentage of patients with a stated preference for either study medication [ Time Frame: Day 2 ]

Secondary Outcome Measures :
  1. Mean ocular discomfort score [ Time Frame: Day 1, 1 minute after drop instillation ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Sign informed consent;
  • Diagnosis of glaucoma or ocular hypertension;
  • On a stable regimen of any intraocular pressure (IOP) lowering medication (mono-therapy);
  • IOP for which, in the opinion of the investigator, participation in the study does not present a risk to ocular health;
  • Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

  • Best corrected visual acuity worse than 0.60 logMAR (20/80 Snellen) in either eye;
  • Pregnant, nursing, or not using highly effective birth control methods;
  • Use of oral or topical corticosteroids within 30 days of the Screening Visit and during the course of the study;
  • History of bronchial asthma or severe chronic obstructive pulmonary disease;
  • Other protocol-defined exclusion criteria may apply.

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT00576342     History of Changes
Other Study ID Numbers: C-07-47
First Posted: December 19, 2007    Key Record Dates
Last Update Posted: July 11, 2014
Last Verified: July 2014

Additional relevant MeSH terms:
Hypertension
Glaucoma
Ocular Hypertension
Vascular Diseases
Cardiovascular Diseases
Eye Diseases
Pharmaceutical Solutions
Ophthalmic Solutions
Timolol
Dorzolamide
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Antihypertensive Agents
Carbonic Anhydrase Inhibitors
Enzyme Inhibitors