Open-angle GlaucomaNCT00823043
A Comfort Survey of Open-angle Glaucoma or Ocular Hypertension Patients Treated With 2 Drugs
An observational study of Open-angle Glaucoma and Ocular Hypertension, run by Vistakon Pharmaceuticals at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Open-angle Glaucoma, Ocular Hypertension
- What is being tested?
- timolol hemihydrate and timolol maleate
- How many people
- 103 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2009to Jul 2009
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Open-angle Glaucoma, Ocular Hypertension
- Being tested
- timolol hemihydrate, timolol maleate
- Medical subject headings
- Glaucoma, Open-Angle, Ocular Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
timolol hemihydrateDrug
timolol hemihydrate 0.5% solution
timolol maleateDrug
timolol maleate in sorbate
| Study group | Role | What they receive |
|---|---|---|
| Timolol hemihydrate | Subjects currently prescribed timolol hemihydrate 0.5% solution. Receives: Drug: timolol hemihydrate | |
| Timolol maleate | Subjects currently prescribed timolol maleate in sorbate. Receives: Drug: timolol maleate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subject Reported Burning/Stinging
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.
Measured: Upon instillation
Subject Reported Tearing
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.
Measured: Upon instillation.
Subject Reported Light Sensitivity
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.
Measured: Upon instillation
Subject Reported Blurred Vision
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.
Measured: Upon instillation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2009 (estimated)
- Study startJan 2009
- Primary completionJul 2009
- Study completionJul 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Open-angle GlaucomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 103 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vistakon Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- William C. Stewart, MD, Study director, PRN Pharmacuetical Research Network, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00823043
- Sponsor's protocol ID
- VPH0110
- Status last verified
- Feb 2015
- First submitted
- 14 Jan 2009
- Last updated
- 6 Mar 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00823043
- Acronym / sponsor ID
- VPH0110
- Conditions
- Open-angle Glaucoma, Ocular Hypertension
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 103 participants (actual)
- Lead sponsor
- Vistakon PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Jan 2009
- Primary completion
- Jul 2009 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 15 Jan 2009 (estimated)
- Results
- Posted 22 Sep 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Timolol hemihydrate | – | Drug: timolol hemihydrateSubjects currently prescribed timolol hemihydrate 0.5% solution. |
| Timolol maleate | – | Drug: timolol maleateSubjects currently prescribed timolol maleate in sorbate. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| timolol hemihydratetimolol hemihydrate 0.5% solution | Drug | Timolol hemihydrate |
| timolol maleatetimolol maleate in sorbate | Drug | Timolol maleate |
Primary outcome
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.
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.
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.
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
William C. Stewart, MD study director
PRN Pharmacuetical Research Network, LLC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Open-angle Glaucoma and Ocular Hypertension, run by Vistakon Pharmaceuticals at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Sep 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Subject Reported Burning/Stinging (time frame: Upon instillation). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2015.