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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Vistakon Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00823043
First received: January 14, 2009
Last updated: September 26, 2011
Last verified: September 2011
  Purpose

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 Intervention
Open-angle Glaucoma
Ocular Hypertension
Drug: timolol hemihydrate
Drug: timolol maleate

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Vistakon Pharmaceuticals:

Primary Outcome Measures:
  • Subject Reported Burning/Stinging [ Time Frame: Upon instillation ] [ Designated as safety issue: No ]
    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.

  • Subject Reported Tearing [ Time Frame: Upon instillation. ] [ Designated as safety issue: No ]
    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.

  • Subject Reported Light Sensitivity [ Time Frame: Upon instillation ] [ Designated as safety issue: No ]
    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.

  • Subject Reported Blurred Vision [ Time Frame: Upon instillation ] [ Designated as safety issue: No ]
    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.


Enrollment: 103
Study Start Date: January 2009
Study Completion Date: July 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
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
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.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00823043

Locations
United States, California
Eye Care of San Diego
San Diego, California, United States, 92103
Sponsors and Collaborators
Vistakon Pharmaceuticals
Investigators
Study Director: William C. Stewart, MD PRN Pharmacuetical Research Network, LLC
  More Information

No publications provided

Responsible Party: Vistakon Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00823043     History of Changes
Other Study ID Numbers: VPH0110
Study First Received: January 14, 2009
Results First Received: August 2, 2010
Last Updated: September 26, 2011
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Glaucoma
Glaucoma, Open-Angle
Hypertension
Ocular Hypertension
Eye Diseases
Vascular Diseases
Cardiovascular Diseases
Timolol
Maleic acid
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
Enzyme Inhibitors

ClinicalTrials.gov processed this record on August 19, 2014