A Comfort Survey of Open-angle Glaucoma or Ocular Hypertension Patients Treated With 2 Drugs
This study has been completed.
Sponsor:
Vistakon Pharmaceuticals
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
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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
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 June 18, 2013