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A Comfort Survey of Open-angle Glaucoma or Ocular Hypertension Patients Treated With 2 Drugs

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00823043
Recruitment Status : Completed
First Posted : January 15, 2009
Results First Posted : September 22, 2010
Last Update Posted : March 6, 2015
Sponsor:
Information provided by (Responsible Party):
Vistakon Pharmaceuticals

Study Description
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Brief Summary:
The objective of the study was to evaluate whether timolol hemihydrate is more comfortable upon instillation than timolol maleate in sorbate. This was an observational study. Subjects with open-angle glaucoma or ocular hypertension were asked to complete a survey regarding their normal treatment. No treatment was prescribed.

Condition or disease Intervention/treatment
Open-angle Glaucoma Ocular Hypertension Drug: timolol hemihydrate Drug: timolol maleate

Study Design
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Study Type : Observational
Actual Enrollment : 103 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Comfort Survey of Open-angle Glaucoma or Ocular Hypertension Patients Treated With Timolol Hemihydrate 0.5% Solution Once or Twice Daily Versus Timolol Maleate in Sorbate
Study Start Date : January 2009
Actual Primary Completion Date : July 2009
Actual Study Completion Date : July 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma

Groups and Cohorts
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Group/Cohort Intervention/treatment
Timolol hemihydrate
Subjects currently prescribed timolol hemihydrate 0.5% solution.
 Drug: timolol hemihydrate
timolol hemihydrate 0.5% solution
Timolol maleate
Subjects currently prescribed timolol maleate in sorbate.
 Drug: timolol maleate
timolol maleate in sorbate


Outcome Measures
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Primary Outcome Measures :
  1. Subject Reported Burning/Stinging [ Time Frame: Upon instillation ]
    Subjects reported burning/stinging after they put the drops in their eyes using the following scale: 0=never, 1=rarely, 2=sometimes, 3=frequently, 4=always.

  2. Subject Reported Tearing [ Time Frame: Upon instillation. ]
    Subjects reported tearing after they put the drops in their eyes using the following scale:0=never, 1=rarely, 2=sometimes, 3=frequently, 4=always.

  3. Subject Reported Light Sensitivity [ Time Frame: Upon instillation ]
    Subjects reported light hurt their eyes after they put the drops in their eyes using the following scale: 0=never, 1=rarely, 2=sometimes, 3=frequently, 4=always.

  4. Subject Reported Blurred Vision [ Time Frame: Upon instillation ]
    Subjects reported their vision was blurred after they put the drops in their eyes using the following scale: 0=never, 1=rarely, 2=sometimes, 3=frequently, 4=always.


Eligibility Criteria
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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The study will be performed in centers in the United States with substantial populations of patients prescribed timolol hemihydrate and timilol maleate in sorbate.
Criteria

Inclusion Criteria:

  • willing to comply with investigator's and protocol's instructions
  • patients signature on the informed consent document
  • open-angle glaucoma or ocular hypertension
  • currently prescribed timolol hemihydrate (once a day (QD) or twice a day (BID))or timolol maleate in sorbate QD as monotherapy or as a part of 2-drug therapy in at least one eye

Exclusion Criteria:

  • inability to understand the trial procedures
  • inability to give informed consent
  • inability to understand, read, or write English
  • best corrected visual acuity of 20/200 or worse in each eye
  • current moderate to severe infectious or inflammatory condition of the eye or eyelids including
  • current moderate to severe dry eye syndrome
  • current chronic use of ocular corticosteroids, ocular surgery or intraocular laser surgery to either eye in the prior 3 months
  • treated with 3 or more glaucoma medicines in both eye
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00823043


Locations
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United States, California
Eye Care of San Diego
San Diego, California, United States, 92103
Sponsors and Collaborators
Vistakon Pharmaceuticals
Investigators
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Study Director: William C. Stewart, MD PRN Pharmacuetical Research Network, LLC
More Information
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Responsible Party: Vistakon Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00823043    
Other Study ID Numbers: VPH0110
First Posted: January 15, 2009    Key Record Dates
Results First Posted: September 22, 2010
Last Update Posted: March 6, 2015
Last Verified: February 2015
Additional relevant MeSH terms:
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Glaucoma
Glaucoma, Open-Angle
Ocular Hypertension
Hypertension
Vascular Diseases
Cardiovascular Diseases
Eye Diseases
Timolol
 Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Antihypertensive Agents