GlaucomaA6111128NCT00950690
Efficacy and Tolerability of Xalatan in Patients
An observational study of Glaucoma and Ocular Hypertension, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 3 sites in 3 countries.
Trial summary
Efficacy data was not collected or analyzed. This study did assess safety and tolerability of Xalatan. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Glaucoma, Ocular Hypertension
- What is being tested?
- Xalatan 0.005% eye drops
- How many people
- 1,289 participants
- Where
- 3 sitesin 3 countries
- Study dates
- Jul 2005to Dec 2007
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: adults with glauocma or ocular hypertension
Who may be able to join
- Patient with ocular hypertension at least 22mg Hg
- Patient must be over 18 years old
Who cannot join
- None listed in the protocol
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
United Arab Emirates1 site
Pfizer Investigational Site
Umm Al Quwain City
About this study
Official title: Observational Study Assessing The Efficacy And Tolerability Of Xalatan™ In Patients With Open Angle Glaucoma And /Or Ocular Hypertension.
Efficacy data was not collected or analyzed. This study did assess safety and tolerability of Xalatan.
Read the detailed description
- Efficacy data not collected or analyzed
- Safety and tolerability of Xalatan assessed NA
- Conditions
- Glaucoma, Ocular Hypertension
- Being tested
- Xalatan 0.005% eye drops
- Keywords
- observational safety study
- Medical subject headings
- Glaucoma, Ocular Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Xalatan 0.005% eye dropsDrug
Also called latanoprost
ophthalmic solution dosed once daily for 3 months
| Study group | Role | What they receive |
|---|---|---|
| Study Drug - Xalatan 0.005% eye drops | Not described Receives: Drug: Xalatan 0.005% eye drops |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraocular Pressure
Intraocular pressure was measured at each visit
Measured: Screening, 10 days, 4 weeks and 12 weeks after beginning treatment
Humphrey Perimetry Visual Field
Analysis of visual field deficits for abnormalities.
Measured: Visits 1 and 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2009 (estimated)
- Study startJul 2005
- Primary completionDec 2007
- Study completionDec 2007
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 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
- Other
- Time perspective
- Prospective
- Enrolment
- 1,289 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00950690
- Sponsor's protocol ID
- A6111128
- Other IDs
- A6111128
- Acronym
- A6111128
- Status last verified
- Feb 2011
- First submitted
- 31 Mar 2009
- Last updated
- 25 Feb 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study Assessing The Efficacy And Tolerability Of Xalatan™ In Patients With Open Angle Glaucoma And /Or Ocular Hypertension.
- ClinicalTrials.gov ID
- NCT00950690
- Acronym / sponsor ID
- A6111128 / A6111128
- Conditions
- Glaucoma, Ocular Hypertension
- Keywords
- observational safety study
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,289 participants (actual)
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.Industry (pharma, biotech, devices)
- Study start
- Jul 2005
- Primary completion
- Dec 2007 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 3 Aug 2009 (estimated)
- Results
- Posted 3 Aug 2009
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Efficacy data was not collected or analyzed. This study did assess safety and tolerability of Xalatan.
Detailed description
- Efficacy data not collected or analyzed
- Safety and tolerability of Xalatan assessed NA
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study Drug - Xalatan 0.005% eye drops | – | Drug: Xalatan 0.005% eye drops |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- adults with glauocma or ocular hypertension
Key inclusion criteria (2 listed)
- Patient with ocular hypertension at least 22mg Hg
- Patient must be over 18 years old
Key exclusion criteria (1 listed)
- None listed in the protocol
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 |
|---|---|---|
| Xalatan 0.005% eye dropsAlso: latanoprostophthalmic solution dosed once daily for 3 months | Drug | Study Drug - Xalatan 0.005% eye drops |
Primary outcome
Intraocular Pressure
Time frame: Screening, 10 days, 4 weeks and 12 weeks after beginning treatment
Intraocular pressure was measured at each visit
Humphrey Perimetry Visual Field
Time frame: Visits 1 and 4
Analysis of visual field deficits for abnormalities.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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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.
Pfizer CT.gov Call Center study director
Pfizer
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Glaucoma and Ocular Hypertension, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 3 sites in 3 countries.
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 1 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 25 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Egypt, Saudi Arabia, United Arab Emirates. 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 3 Aug 2009). 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?
Intraocular Pressure (time frame: Screening, 10 days, 4 weeks and 12 weeks after beginning treatment). The study lists 2 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 25 Feb 2021.