Patient Preference Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT00576342
First received: December 17, 2007
Last updated: July 9, 2014
Last verified: July 2014
  Purpose

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


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

Study Type: Interventional
Study Design: Allocation: Randomized
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:


Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • Percentage of patients with a stated preference for either study medication [ Time Frame: Day 2 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Mean ocular discomfort score [ Time Frame: Day 1, 1 minute after drop instillation ] [ Designated as safety issue: No ]

Enrollment: 129
Study Start Date: December 2007
Study Completion Date: January 2008
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.
  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: NCT00576342     History of Changes
Other Study ID Numbers: C-07-47
Study First Received: December 17, 2007
Last Updated: July 9, 2014
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Additional relevant MeSH terms:
Glaucoma
Hypertension
Ocular Hypertension
Eye Diseases
Vascular Diseases
Cardiovascular Diseases
Timolol
Dorzolamide
Ophthalmic Solutions
Pharmaceutical Solutions
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
Carbonic Anhydrase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on August 01, 2014