GlaucomaNCT00382122
Prevalence of Ocular Surface Disease in Glaucoma Patients
An observational study of Glaucoma, run by Alcon Research at 1 site in United States.
Trial summary
Demographic information and a brief medical and concomitant medicine history will be obtained from the glaucoma patient's records. Qualified patients will be asked to complete a questionnaire about their symptoms. Patients will then be scheduled to undergo three standard clinical tests of the ocular surface. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glaucoma
- How many people
- 101 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2006to Feb 2007
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients 18 years or older with open-angle glaucoma or ocular hypertension were consecutively recruited for the study.
Who may be able to join
- Diagnosis of glaucoma;
- Other protocol-defined inclusion criteria may apply.
Who cannot join
- Inability to understand trial procedures;
- Inability to understand Informed Consent;
- Current use or use within the last 3 months of Restasis, steroids, or topical ocular non-steroidal anti-inflammatory drugs;
- Punctal plugs;
- Previous glaucoma, corneal, or conjunctival surgery;
- Other protocol-defined exclusion criteria may apply.
Trial locations and contacts
1 site in 1 country.
About this study
Demographic information and a brief medical and concomitant medicine history will be obtained from the glaucoma patient's records. Qualified patients will be asked to complete a questionnaire about their symptoms. Patients will then be scheduled to undergo three standard clinical tests of the ocular surface.
- Conditions
- Glaucoma
- Keywords
- Glaucoma, Ocular hypertension, Dry eye, Ocular surface disease
- Medical subject headings
- Glaucoma, Ocular Hypertension, Dry Eye Syndromes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2006 (estimated)
- Study startSep 2006
- Primary completionFeb 2007
- Study completionFeb 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for GlaucomaStudies of the same condition, open and under way.
- More trials run by Alcon ResearchThe sponsor's other registered studies.
- 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
- Cross-sectional
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alcon Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Felipe Medeiros, MD, PhD, Study director, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00382122
- Sponsor's protocol ID
- CMS-06-06
- Status last verified
- Sep 2007
- First submitted
- 27 Sep 2006
- Last updated
- 28 May 2012
- Results posted
- No
Publications
Leung EW, Medeiros FA, Weinreb RN. Prevalence of ocular surface disease in glaucoma patients. J Glaucoma. 2008 Aug;17(5):350-5. doi: 10.1097/IJG.0b013e31815c5f4f.
PubMed 18703943
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Ocular Surface Disease in Glaucoma Patients
- ClinicalTrials.gov ID
- NCT00382122
- Acronym / sponsor ID
- CMS-06-06
- Conditions
- Glaucoma
- Keywords
- Glaucoma, Ocular hypertension, Dry eye, Ocular surface disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- Alcon ResearchIndustry (pharma, biotech, devices)
- Study start
- Sep 2006
- Primary completion
- Feb 2007 (actual)
- Study completion
- Feb 2007 (actual)
- First posted
- 28 Sep 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Demographic information and a brief medical and concomitant medicine history will be obtained from the glaucoma patient's records. Qualified patients will be asked to complete a questionnaire about their symptoms. Patients will then be scheduled to undergo three standard clinical tests of the ocular surface.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients 18 years or older with open-angle glaucoma or ocular hypertension were consecutively recruited for the study.
Key inclusion criteria (2 listed)
- Diagnosis of glaucoma;
- Other protocol-defined inclusion criteria may apply.
Key exclusion criteria (6 listed)
- Inability to understand trial procedures;
- Inability to understand Informed Consent;
- Current use or use within the last 3 months of Restasis, steroids, or topical ocular non-steroidal anti-inflammatory drugs;
- Punctal plugs;
- Previous glaucoma, corneal, or conjunctival surgery;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2012.
- Results publication: PubMed 18703943Leung EW, Medeiros FA, Weinreb RN. Prevalence of ocular surface disease in glaucoma patients. J Glaucoma. 2008 Aug;17(5):350-5. doi: 10.1097/IJG.0b013e31815c5f4f.
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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.
Felipe Medeiros, MD, PhD study director
University of California, San Diego
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 Glaucoma, run by Alcon Research 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 2 inclusion and 6 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 28 May 2012. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00382122, which also lists 1 linked publication.
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 28 May 2012.