Glaucoma,Open-AngleNCT00486252

Non Interventional Study in Patients With Open Angle Glaucoma and/or Ocular Hypertension Treated With XALATAN®

An observational study of Glaucoma,Open-Angle and Ocular Hypertension, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc..

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The primary objective is to evaluate the Intraocular pressure reducing effect of Xalatan over 3 months. The secondary objective is to study the other efficacy parameters during treatment for 3 months Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Glaucoma,Open-Angle, Ocular Hypertension
What is being tested?: Observational
How many people: 996 participants
Where: No sites listed yet
Study dates: Jun 2007to Jan 2008
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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Study population: outpatients with unilateral or bilateral open angle glaucoma or ocular hypertension

Who may be able to join

Unilateral or bilateral open angle glaucoma or ocular hypertension (IOP (Intraocular Pressure) ≥ 21 mmHg at diagnosis).
Naive patients (no prior anti-glaucoma pharmacological or surgical treatment) and patients with beta-blockers therapy failure
Visual acuity (best corrected) equal to or better than 6/6

Who cannot join

closed/barely open anterior chamber angle or history of acute angle closure glaucoma.
history of any antiglaucoma surgical treatment (Argon Laser Trabeculoplasty and/or any ocular filtering surgical intervention).
ocular surgery (on the globe of the eye only), or inflammation/infection within 3 months prior to baseline visit. (Applies to both fellow and study eyes.)
other abnormal ocular conditions or symptoms preventing the patient from entering the study, in the investigator's clinical judgement.

About this study

Official title: Non Interventional Study in Patients With Open Angle Glaucoma and/or Ocular Hypertension Treated With XALATAN® (Latanoprost) as First-Line Monotherapy and as Second-Line Monotherapy After Beta-Blockers Therapy Failure

The primary objective is to evaluate the Intraocular pressure reducing effect of Xalatan over 3 months. The secondary objective is to study the other efficacy parameters during treatment for 3 months

Conditions: Glaucoma,Open-Angle, Ocular Hypertension
Being tested: Observational
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.

ObservationalOther
This is a non-interventional study. Subgroups of naïve patients and patients with previous failure to beta-blockers therapy were analyzed.

Study groups in NCT00486252
Study group	Role	What they receive
This is N/A due to the above description.		This is N/A due to the above description. Receives: Other: Observational

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Intraocular Pressure (IOP): Baseline to Month 3
Change: IOP at observation minus IOP at baseline. IOP was measured with the non-contact or Goldmann tonometer for a given subject. Three measurements were performed in each eye alternating between the eyes, starting with the right eye. The mean of the 3 measurements was used and if both eyes were study eyes, the mean of the 2 eyes was used.
Measured: Baseline, Month 3

Secondary outcomes (2)

Percentage Change in Intraocular Pressure (IOP)
Percentage change in IOP calculated as 100 times (IOP at Observation minus IOP at Baseline) divided by IOP at Baseline.
Measured: Month 1, Month 3
Categorized Percentage Change in Intraocular Pressure (IOP)
Percentage change=100 times (IOP at observation minus IOP at Baseline) divided by IOP at Baseline. Percentage change in each patient assigned to the following: Increase or no change in IOP (percentage change greater than or equal to 0); Percentage reduction of up to 20% (-20 less than or equal to percentage change < 0); Percentage reduction greater than 20% (percentage change < -20).
Measured: Month 1, Month 3

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2007Jan 2008

First posted14 Jun 2007 (estimated)
Study startJun 2007
Primary completionJan 2008
Study completionJan 2008

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 Glaucoma,Open-AngleStudies 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: Case only
Time perspective: Prospective
Enrolment: 996 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00486252
Sponsor's protocol ID: A6111138
Status last verified: Nov 2009
First submitted: 12 Jun 2007
Last updated: 1 Mar 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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Study at a glance

From the registry record, last updated by the sponsor on 1 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Non Interventional Study in Patients With Open Angle Glaucoma and/or Ocular Hypertension Treated With XALATAN® (Latanoprost) as First-Line Monotherapy and as Second-Line Monotherapy After Beta-Blockers Therapy Failure
ClinicalTrials.gov ID: NCT00486252
Acronym / sponsor ID: A6111138
Conditions: Glaucoma,Open-Angle, Ocular Hypertension
Study type: Observational
Recruitment status: Completed
Enrolment: 996 participants (actual)
Lead sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.Industry (pharma, biotech, devices)
Study start: Jun 2007
Primary completion: Jan 2008 (actual)
Study completion: Jan 2008 (actual)
First posted: 14 Jun 2007 (estimated)
Results: Posted 16 Jul 2009

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The primary objective is to evaluate the Intraocular pressure reducing effect of Xalatan over 3 months. The secondary objective is to study the other efficacy parameters during treatment for 3 months

Study design

Observational model: Case only
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
This is N/A due to the above description.	–	Other: ObservationalThis is N/A due to the above description.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: outpatients with unilateral or bilateral open angle glaucoma or ocular hypertension

Key inclusion criteria (3 listed)

Unilateral or bilateral open angle glaucoma or ocular hypertension (IOP (Intraocular Pressure) ≥ 21 mmHg at diagnosis).
Naive patients (no prior anti-glaucoma pharmacological or surgical treatment) and patients with beta-blockers therapy failure
Visual acuity (best corrected) equal to or better than 6/6

Key exclusion criteria (4 listed)

closed/barely open anterior chamber angle or history of acute angle closure glaucoma.
history of any antiglaucoma surgical treatment (Argon Laser Trabeculoplasty and/or any ocular filtering surgical intervention).
ocular surgery (on the globe of the eye only), or inflammation/infection within 3 months prior to baseline visit. (Applies to both fellow and study eyes.)
other abnormal ocular conditions or symptoms preventing the patient from entering the study, in the investigator's clinical judgement.

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
ObservationalThis is a non-interventional study. Subgroups of naïve patients and patients with previous failure to beta-blockers therapy were analyzed.	Other	This is N/A due to the above description.

Primary outcome

Change in Intraocular Pressure (IOP): Baseline to Month 3
Time frame: Baseline, Month 3
Change: IOP at observation minus IOP at baseline. IOP was measured with the non-contact or Goldmann tonometer for a given subject. Three measurements were performed in each eye alternating between the eyes, starting with the right eye. The mean of the 3 measurements was used and if both eyes were study eyes, the mean of the 2 eyes was used.

2 secondary outcomes

Percentage Change in Intraocular Pressure (IOP)
Time frame: Month 1, Month 3
Categorized Percentage Change in Intraocular Pressure (IOP)
Time frame: Month 1, Month 3

Results and safety

Results posted to the registry on 16 Jul 2009, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Latanoprost All Subjects	996	938

Primary outcome: Change in Intraocular Pressure (IOP): Baseline to Month 3

Time frame: Baseline, Month 3. Mean (Standard Deviation). Unit: mmHg

Measure	Latanoprost (All Subjects) n = 945	Latanoprost (no Prior Beta-blocker Therapy) n = 402	Latanaprost (Prior Beta-blocker Failure) n = 531
Value	-5.3 (3.9)	-6.8 (3.8)	-4.1 (3.5)

Population analysed: Full Analysis Set (FAS) included all patients who received at least 1 dose of latanoprost (Xalatan®), had baseline IOP recorded, \& at least one postbaseline IOP measure recorded (at either Month 1 or Month 3). No imputation techniques used for missing data; only observed data reported. "n"=number of participants in each group for that category.

2 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Latanoprost All Subjects	0 of 996 (0%)	122 of ?	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 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

Questions about this trial

What is this clinical trial studying?

An observational study of Glaucoma,Open-Angle and Ocular Hypertension, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc..

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 3 inclusion and 4 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 1 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.

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 16 Jul 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?

Change in Intraocular Pressure (IOP): Baseline to Month 3 (time frame: Baseline, Month 3). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00486252.

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 1 Mar 2021.