GlaucomaXCHANGENCT01012245

Non-Interventional Study In Patients With Ocular Hypertension And Open Angle Glaucoma Treated With Xalatan And Xalacom

An observational study of Glaucoma 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

Non-interventional study to obtain real life data from the treatment with Xalatan and Xalacom in Germany and to assess the long-term efficacy and tolerability under routine conditions. Data were entered into an electronic case report form. Read more about this study

Who is it for?: Any age
Conditions the study is for: Glaucoma, Ocular Hypertension
How many people: 28,812 participants
Where: No sites listed yet
Study dates: Jan 2000to Dec 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 Any age
All sexes
No healthy volunteers
Child, Adult, Older adult

Study population: patients with glaucoma or ocular hypertension treated by office-based ophthalmologists

Who may be able to join

patients with ocular hypertension or glaucoma, defined by SmPC

Who cannot join

defined by SmPC

About this study

Official title: Project "XCHANGE" Non-Interventional Study

Conditions: Glaucoma, Ocular Hypertension
Being tested: no intervention
Keywords: Xchange, Xalatan, Xalacom, Betablocker, observational, longterm
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.

no interventionOther

Study groups in NCT01012245
Study group	Role	What they receive
patients with glaucoma and ocular hypertension		Not described Receives: Other: no intervention

What is being measured

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

Change From Baseline in Intraocular Pressure (IOP)
Mean IOP values measured by applanation tonometry. Only Goldman values are displayed; if values were given for both right and left eye, the value of the right eye was analyzed. Change (absolute difference) calculated as mean of (value of IOP at observation minus baseline value). Study course is reported by yearly intervals and clustered as 1 year (12±3 months), 2 years (24±3 months), and 3 years (36±3 months).
Measured: Baseline, 1 year, 2 years, and 3 years
Aulhorn Stage (Visual Field Defects)
Number of subjects at each Aulhorn stage. Staged as: No scotoma; Stage I (relative scotomas only), Stage II (absolute scotomas without connection to the blind spot), Stage III (absolute scotomas with connection to the blind spot), Stage IV (absolute scotomas more than 1 quadrant affected), and Stage V (temporal residual visual field only). If values were given for both right and left eye, the value of the right eye was analyzed.
Measured: Baseline, 1 year, 2 years, and 3 years
Change From Baseline in Optic Disc Excavation: Vertical Cup to Disc Ratio
Mean vertical cup to disc (cup/disc or C/D) ratio to assess the progression of glaucoma; calculated as the ratio of the diameter of the depression (cup) to that of the optical nerve head (disc). If values were given for both right and left eye, the value of the right eye was analyzed. Change calculated as mean of (value of cup/disc ratio at observation minus baseline value).
Measured: Baseline, 1 year, 2 years, and 3 years
Change From Baseline in Optic Disc Excavation: Horizontal Cup to Disc Ratio
Mean horizontal cup to disc (cup/disc or C/D) ratio to assess the progression of glaucoma; calculated as the ratio of the diameter of the depression (cup) to that of the optical nerve head (disc). If values were given for both right and left eye, the value of the right eye was analyzed. Change calculated as mean of (value of cup/disc ratio at observation minus baseline value).
Measured: Baseline, 1 year, 2 years, and 3 years

Secondary outcomes (9)

Investigator Assessment of Xalatan® Efficacy
Number of subjects for Investigator assessment of the efficacy of Xalatan® treatment rated as excellent (highly effective), very good, good, moderate, sufficient, and insufficient (not effective).
Measured: Baseline, 1 year, 2 years, and 3 years
Subject Assessment of Satisfaction With Xalatan® Treatment
Number of subjects for assessment of subject satisfaction with Xalatan® treatment; categorized as excellent (full satisfaction), very good, good, moderate, sufficient, and insufficient (no satisfaction).
Measured: Baseline, 1 year, 2 years, and 3 years
Visual Acuity (Visus)
Number of subjects with visual acuity evaluations: amaurosis (partial or total loss of sight); hand movements (able to detect gross object and motion perception without detailed discrimination); finger count (able to count fingers at a given distance); visual acuity scale: range 0.05 (low acuity) to >1.2 (greater acuity). If values were given for both the right eye and left eye, the value of the right eye was analyzed.
Measured: Baseline, 1 year, 2 years, and 3 years
Visual Impairment Due to Glaucoma
Number of subjects per level of visual impairment categorized as not at all (no impairment), a little bit, moderate, severe, and very severe (very severe impairment).
Measured: Baseline, 1 year, 2 years, and 3 years
Subject Self-care: Application of Eye Drops
Number of subjects per level of ability for application (administration) of eye drops categorized as without the help of nursing staff (apply without help) and with the help of nursing staff (apply with help).
Measured: Baseline, 1 year, 2 years, and 3 years
Reasons for Changes in Glaucoma Therapy
Number of subjects for each reason for change of therapy; there may be more than one reason possible per patient. Reasons for changes in glaucoma therapy was reported from January 2000 through December 2008 independent of the duration of any individual subject's time on study.
Measured: January 2000 through December 2008
Investigator Assessment of Tolerability of Xalatan® Treatment
Number of subjects for the Investigator's assessment of subjects tolerability of Xalatan® treatment categorized as excellent, very good, good, moderate, sufficient, or insufficient. The occurrence of adverse events (a side effect that may not have any causal relationship to study treatment) was documented as tolerability data.
Measured: Baseline up to 3 years
Reasons for Discontinuation From Study
Number of subjects per reason for discontinuation from the study. More than one reason for discontinuation is possible per patient. Discontinuation analysis was performed independent of the duration of any individual subject's time on study.
Measured: January 2000 through December 2008
Changes to the Color of the Iris During Xalatan® or Xalacom® Treatment
Number of subjects with documented change to the color of the iris during treatment with Xalatan® or Xalacom®.
Measured: Baseline up to 3 years

Timeline

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

Jan 2000Dec 2008

First posted13 Nov 2009 (estimated)
Study startJan 2000
Primary completionDec 2008
Study completionDec 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 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: 28,812 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01012245
Sponsor's protocol ID: 912-OPT-0091-131
Other IDs: A6111100, 912-OPT-0091-131
Acronym: XCHANGE
Status last verified: Feb 2010
First submitted: 11 Nov 2009
Last updated: 25 Feb 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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All Glaucoma trials

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: Project "XCHANGE" Non-Interventional Study
ClinicalTrials.gov ID: NCT01012245
Acronym / sponsor ID: XCHANGE / 912-OPT-0091-131
Conditions: Glaucoma, Ocular Hypertension
Keywords: Xchange, Xalatan, Xalacom, Betablocker, observational, longterm
Study type: Observational
Recruitment status: Completed
Enrolment: 28,812 participants (actual)
Lead sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.Industry (pharma, biotech, devices)
Study start: Jan 2000
Primary completion: Dec 2008 (actual)
Study completion: Dec 2008 (actual)
First posted: 13 Nov 2009 (estimated)
Results: Posted 21 Jan 2010

Clinical summary

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

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
patients with glaucoma and ocular hypertension	–	Other: no intervention

Who may qualify

Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult
Study population: patients with glaucoma or ocular hypertension treated by office-based ophthalmologists

Key inclusion criteria (1 listed)

patients with ocular hypertension or glaucoma, defined by SmPC

Key exclusion criteria (1 listed)

defined by SmPC

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
no intervention	Other	patients with glaucoma and ocular hypertension

Primary outcome

Change From Baseline in Intraocular Pressure (IOP)
Time frame: Baseline, 1 year, 2 years, and 3 years
Mean IOP values measured by applanation tonometry. Only Goldman values are displayed; if values were given for both right and left eye, the value of the right eye was analyzed. Change (absolute difference) calculated as mean of (value of IOP at observation minus baseline value). Study course is reported by yearly intervals and clustered as 1 year (12±3 months), 2 years (24±3 months), and 3 years (36±3 months).
Aulhorn Stage (Visual Field Defects)
Time frame: Baseline, 1 year, 2 years, and 3 years
Number of subjects at each Aulhorn stage. Staged as: No scotoma; Stage I (relative scotomas only), Stage II (absolute scotomas without connection to the blind spot), Stage III (absolute scotomas with connection to the blind spot), Stage IV (absolute scotomas more than 1 quadrant affected), and Stage V (temporal residual visual field only). If values were given for both right and left eye, the value of the right eye was analyzed.
Change From Baseline in Optic Disc Excavation: Vertical Cup to Disc Ratio
Time frame: Baseline, 1 year, 2 years, and 3 years
Mean vertical cup to disc (cup/disc or C/D) ratio to assess the progression of glaucoma; calculated as the ratio of the diameter of the depression (cup) to that of the optical nerve head (disc). If values were given for both right and left eye, the value of the right eye was analyzed. Change calculated as mean of (value of cup/disc ratio at observation minus baseline value).
Change From Baseline in Optic Disc Excavation: Horizontal Cup to Disc Ratio
Time frame: Baseline, 1 year, 2 years, and 3 years
Mean horizontal cup to disc (cup/disc or C/D) ratio to assess the progression of glaucoma; calculated as the ratio of the diameter of the depression (cup) to that of the optical nerve head (disc). If values were given for both right and left eye, the value of the right eye was analyzed. Change calculated as mean of (value of cup/disc ratio at observation minus baseline value).

9 secondary outcomes

Investigator Assessment of Xalatan® Efficacy
Time frame: Baseline, 1 year, 2 years, and 3 years
Subject Assessment of Satisfaction With Xalatan® Treatment
Time frame: Baseline, 1 year, 2 years, and 3 years
Visual Acuity (Visus)
Time frame: Baseline, 1 year, 2 years, and 3 years
Visual Impairment Due to Glaucoma
Time frame: Baseline, 1 year, 2 years, and 3 years
Subject Self-care: Application of Eye Drops
Time frame: Baseline, 1 year, 2 years, and 3 years
Reasons for Changes in Glaucoma Therapy
Time frame: January 2000 through December 2008
Investigator Assessment of Tolerability of Xalatan® Treatment
Time frame: Baseline up to 3 years
Reasons for Discontinuation From Study
Time frame: January 2000 through December 2008
Changes to the Color of the Iris During Xalatan® or Xalacom® Treatment
Time frame: Baseline up to 3 years

Results and safety

Results posted to the registry on 21 Jan 2010, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Subjects With Glaucoma and Ocular Hypertension	28,812	26,385

Primary outcome: Change From Baseline in Intraocular Pressure (IOP)

Time frame: Baseline, 1 year, 2 years, and 3 years. Mean (Standard Deviation). Unit: mm Hg

Measure	All Subjects n = 20073	Xalatan® n = 8735	Betablockers n = 1508	Xalacom® n = 494	Other Medications n = 9336
1 year (n=10886,4134, 357, 209, 3029)	-1.5 (4.4)	-0.7 (3.5)	-1.0 (3.4)	-0.2 (3.5)	-1.1 (4.6)
2 years (n=7558, 2631, 175, 80, 1834)	-1.6 (4.5)	-0.7 (3.6)	-0.8 (3.2)	-0.5 (3.1)	-1.4 (4.6)
3 years (n=5023, 1753, 64, 40, 1115)	-1.6 (4.5)	-0.7 (3.7)	-1.2 (3.1)	-0.3 (3.2)	-1.4 (4.4)

All Subjects: Mean value: 17.2 (95% CI 17.2 to 17.3)
Xalatan®: Mean value: 16.9 (95% CI 16.8 to 17.0)
Betablockers: Mean value: 17.3 (95% CI 17.1 to 17.5)

Population analysed: All subjects group and each treatment group population. N=number of participants with IOP data at baseline; (n)=number of participants with analyzable data at observation for All subjects, Xalatan®, Betablockers, Xalacom®, and Other medications, respectively.

Primary outcome: Aulhorn Stage (Visual Field Defects)

Time frame: Baseline, 1 year, 2 years, and 3 years. Number. Unit: participants

Measure	All Subjects n = 28812	Xalatan® n = 13486	Betablockers n = 1884	Xalacom® n = 746	Other Medications n = 12696
Baseline: No scotoma	7753	4074	493	200	2986
Baseline: Stage I	3759	1915	254	68	1522
Baseline: Stage II	1904	826	119	47	912
Baseline: Stage III	1313	467	51	57	738
Baseline: Stage IV	949	268	29	17	635
Baseline: Stage V	646	210	13	8	415
Baseline: missing values	12488	5726	925	349	5488
1 year: No scotoma	4493	2068	157	94	903

Population analysed: All subjects group and all treatment groups populations

Primary outcome: Change From Baseline in Optic Disc Excavation: Vertical Cup to Disc Ratio

Time frame: Baseline, 1 year, 2 years, and 3 years. Mean (Standard Deviation). Unit: ratio

Measure	All Subjects n = 20375	Xalatan® n = 9521	Betablockers n = 1276	Xalacom® n = 497	Other Medications n = 9081
1 year (n=11190, 4638, 72, 236, 2714)	0.00 (0.07)	0.00 (0.07)	0.02 (0.08)	0.01 (0.07)	0.00 (0.08)
2 years (n=8088, 3128, 26, 93, 1756)	0.01 (0.08)	0.01 (0.08)	0.00 (0.09)	0.02 (0.07)	0.01 (0.08)
3 years (n=5784, 2173, 16, 34, 1170)	0.01 (0.09)	0.01 (0.08)	0.03 (0.09)	0.02 (0.11)	0.01 (0.10)

All Subjects: Mean value: 0.46 (95% CI 0.46 to 0.47)
Xalatan®: Mean value: 0.44 (95% CI 0.43 to 0.44)
Betablockers: Mean value: 0.39 (95% CI 0.35 to 0.43)

Population analysed: All subjects group and all treatment groups populations. N=number of participants with optic disc excavation data at baseline; (n)=number of participants with analyzable data at observation for All subjects, Xalatan®, Betablockers, Xalacom®, and Other medications, respectively.

Primary outcome: Change From Baseline in Optic Disc Excavation: Horizontal Cup to Disc Ratio

Time frame: Baseline, 1 year, 2 years, and 3 years. Mean (Standard Deviation). Unit: ratio

Measure	All Subjects n = 19316	Xalatan® n = 9203	Betablockers n = 1226	Xalacom® n = 469	Other Medications n = 8418
1 year (n=10602, 4496, 71, 227, 2442)	0.00 (0.07)	0.00 (0.06)	0.02 (0.08)	0.01 (0.07)	0.00 (0.08)
2 years (n=7727, 3003, 26, 88, 1630)	0.00 (0.08)	0.00 (0.07)	0.00 (0.10)	0.01 (0.06)	0.01 (0.09)
3 years (n=5500, 2089, 16, 33, 1067)	0.01 (0.09)	0.01 (0.07)	0.01 (0.08)	0.02 (0.11)	0.01 (0.10)

All Subjects: Mean value: 0.45 (95% CI 0.45 to 0.46)
Xalatan®: Mean value: 0.42 (95% CI 0.42 to 0.43)
Betablockers: Mean value: 0.37 (95% CI 0.33 to 0.42)

Population analysed: All subjects group and all treatment groups populations. N=number of subjects with optic disc excavation data at baseline; (n)=number of subjects with analyzable data at observation for All subjects, Xalatan®, Betablockers, Xalacom®, and Other medications, respectively.

9 secondary outcomes are reported in the full results.

Adverse events

Time frame: Data for Adverse drug reactions was reported January 2000 through December 2008 through the duration of the study independent of the duration of any individual subject's time on study.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
All Subjects	0 of 28,812 (0%)	6,936 of 28,812 (24.1%)	Not reported

Limitations and caveats (from the sponsor): Except at baseline, number of subjects analyzed in treatment groups do not necessarily summarize to "All subjects" total; subjects drop out of treatment group when therapy changes. "All subjects" shows all subjects irrespective of any therapy change.

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

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..

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 1 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.

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 21 Jan 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?

Change From Baseline in Intraocular Pressure (IOP) (time frame: Baseline, 1 year, 2 years, and 3 years). 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?

On the ClinicalTrials.gov record for NCT01012245.

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.