Low Tension GlaucomaNTG-X-PERTNCT01209624

Observational Study of the Long-term Effect of Latanoprost in Normal Tension Glaucoma

An observational study of Low Tension Glaucoma, 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.

Trial summary

The purpose of this study is to assess the long-term efficacy and safety of latanoprost monotherapy in patients with normal tension glaucoma (NTG) using a prospective, observational design. Visits were scheduled at 6-month intervals for 24 months. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Low Tension Glaucoma
How many people: 902 participants
Where: No sites listed yet
Study dates: Aug 2006to Sep 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 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Study population: Glaucoma subjects

Who may be able to join

patients with normal-tension glaucoma

Who cannot join

none

About this study

Official title: Prospective, Observational Study to Investigate the Long-term Effect of Xalatan® on Intraocular Pressure (IOP) and on Maintenance of Visual Field in Patients With Normal Tension Glaucoma (NTG)

Conditions: Low Tension Glaucoma
Keywords: prospective, non-interventional, observational, multi-center, long-term
Medical subject headings: Low Tension Glaucoma

What is being measured

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

Change From Baseline in Raw Intraocular Pressure (IOP) by Visit
Mean IOP values measured by applanation tonometry or noncontact method; valid range: 8-40 millimeters of mercury (mmHg). Only the IOP reading for the eye treated with Xalatan® was used; if both eyes were treated, the value of the right eye was analyzed. Last visit = last post-baseline visit at which participant provides a value of IOP.
Measured: Baseline, Month 6, Month 12, Month 18, Month 24, Last Visit
Number of Participants With a 24-Hour Intraocular Pressure (IOP) Profile: Month 12
Response: Yes = had an IOP 24-hour profile; No = did not have an IOP 24-hour profile.
Measured: Month 12
Number of Participants With a 24-Hour Intraocular Pressure (IOP) Profile: Month 24
Response: Yes = had an IOP 24-hour profile; No = did not have an IOP 24-hour profile.
Measured: Month 24
Number of Participants Per Visit With Intraocular Pressure (IOP) 24-Hour Pressure Peaks: Month 12
Response: Yes = had IOP 24-hour pressure peak; No = did not have IOP 24-hour pressure peak.
Measured: Month 12
Number of Participants Per Visit With Intraocular Pressure (IOP) 24-Hour Pressure Peaks: Month 24
Response: Yes = had IOP 24-hour pressure peak; No = did not have IOP 24-hour pressure peak.
Measured: Month 24
Percentage of Participants Who Achieved Intraocular Pressure (IOP) Target at Last Visit
Percentage of participants who achieved their IOP target set at baseline. Response: Yes = achieved IOP target at last vist; No = did not achieve IOP target at last visit.
Measured: Month 24, (or last visit)
Change From Baseline by Visit in Optic Disc Excavation: Horizontal Cup to Disc Ratio
Mean horizontal cup to disc (cup/disc or C/D) ratio measured by slit lamp examination to assess progression of glaucoma; calculated as the ratio of the diameter of the depression (cup) to that of the optical nerve head (disc). Valid range: 0.1-1.0. Only data for the eye treated with Xalatan® was used; if both eyes were treated, the value of the right eye was analyzed.
Measured: Baseline, Month 6, Month 12, Month 18, Month 24, Last Visit
Change From Baseline by Visit in Optic Disc Excavation: Vertical Cup to Disc Ratio
Mean vertical cup to disc (cup/disc or C/D) ratio measured by slit lamp examination to assess progression of glaucoma; calculated as the ratio of the diameter of the depression (cup) to that of the optical nerve head (disc). Valid range: 0.1-1.0; a high cup/disc ratio may imply glaucoma. Only data for the eye treated with Xalatan® was used; if both eyes were treated, the value of the right eye was analyzed.
Measured: Baseline, Month 6, Month 12, Month 18, Month 24, Last Visit
Number of Participants With Optic Disc Hemorrhage by Visit: Month 6
Presence of optic disc hemorrhages assessed by slip lamp examination. Only data for eye were treated with Xalatan® was used; if both eyes were treated, the value of the right eye was analyzed.
Measured: Month 6
Number of Participants With Optic Disc Hemorrhage by Visit: Month 12
Presence of optic disc hemorrhages assessed by slip lamp examination. Only data for eye were treated with Xalatan® was used; if both eyes were treated, the value of the right eye was analyzed.
Measured: Month 12
Number of Participants With Optic Disc Hemorrhage by Visit: Month 18
Presence of optic disc hemorrhages assessed by slip lamp examination. Only data for eye were treated with Xalatan® was used; if both eyes were treated, the value of the right eye was analyzed.
Measured: Month 18
Number of Participants With Optic Disc Hemorrhage by Visit: Month 24
Presence of optic disc hemorrhages assessed by slip lamp examination. Only data for eye were treated with Xalatan® was used; if both eyes were treated, the value of the right eye was analyzed.
Measured: Month 24
Change From Baseline in Heidelberg Retina Tomograph (HRT) Parameters: Rim Area
Rim area (millimeter [mm]2) right and left eye assessed by HRT imaging. Valid range: 0.500 to 1.900 mm2. Only the rim area for the eye treated with Xalatan® was used; if both eyes were treated, the value of the right eye was analyzed.
Measured: Baseline, Month 6, Month 12, Month 18, Month 24, Last Visit
Change From Baseline in Heidelberg Retina Tomograph (HRT) Parameters: Rim Volume
Rim volume (mm3) right and left eye assessed by HRT imaging. Valid range: 0.080 to 0.700 mm3. Only the rim volume for the eye treated with Xalatan® was used; if both eyes were treated, the value of the right eye was analyzed.
Measured: Baseline, Month 6, Month 12, Month 18, Month 24, Last Visit
Change From Baseline in Heidelberg Retina Tomograph Parameters: Cup Shape Measure
Cup shape measure right and left eye assessed by HRT imaging . Valid range: -0.400 to -0.010. Only the cup shape measure for the eye treated with Xalatan® was used; if both eyes were treated, the value of the right eye was analyzed.
Measured: Baseline, Month 6, Month 12, Month 18, Month 24, Last Visit
Change From Baseline in Heidelberg Retina Tomograph (HRT) Parameters: Mean RNFL Thickness
Mean retinal nerve fiber layer (RNFL) thickness in millimeters (mm) right and left eye assessed by HRT imaging. Valid range: 0.100 to 0.400 mm. Only the RNFL for the eye treated with Xalatan® was used; if both eyes were treated, the value of the right eye was analyzed.
Measured: Baseline, Month 6, Month 12, Month 18, Month 24, Last Visit
Number of Participants With Change From Baseline to Month 24 in Aulhorn Stages
Values of change in Aulhorn Stage measured by Humphrey Visual Field Analyzer. Aulhorn stages: no scotoma, Stage I (relative scotomas only), Stage II (absolute scotomas without connection to blind spot), Stage III (absolute scotomas with connection to blind spot), Stage IV (absolute scotomas more than 1 quadrant affected), and Stage V (temporal residual visual field only). If both eyes were treated with Xalantan® the value of right eye was analyzed; otherwise, only the assessment for the eye treated with study medication was used.
Measured: Baseline, Month 24
Number of Participants With Change From Baseline to Month 24 in Visual Field Defect
Change in mean defect right and left eye; valid range: -30 - + 30 decibels (dB). Visual field defect categories: preperimetric glaucoma: ≥ -2 dB; mild damage: < -2 dB and ≥ -3.3 dB; moderate damage: < -3.3 dB and ≥ -4.6 dB; and severe damage: < -4.6 dB. If both eyes were treated with Xalatan® , the value for the right eye was used; otherwise, only the mean defect value for the eye treated with study medication was used.
Measured: Baseline, Month 24
Number of Participants With Investigator Assessments of Efficacy at Month 24
Number of participants with Investigator assessments of the efficacy of Xalatan® treatment rated as: 1=very good, 2=good, 3=moderate, 4=insufficient. If study medication was stopped before 24 months, assessment was performed at the time of early termination.
Measured: Month 24
Number of Participants With Individual Progression of Glaucoma Damage: Horizontal Cup to Disc Ratio and/or Vertical Cup to Disc Ratio
Increase in Horizontal Cup to Disc Ratio and/or Vertical Cup to Disc Ratio by at least 0.2 (Last Visit minus Baseline).
Measured: Month 24 (or last visit)
Number of Participants With Individual Progression of Glaucoma Damage: Optic Disc Hemorrhage
Participants with at least one post-baseline optic disc hemorrhage.
Measured: Month 24 (or last visit)
Number of Participants With Individual Progression of Glaucoma Damage: Rim Area, Rim Volume, or Mean Retinal Nerve Fiber Layer (RNFL) Thickness
Decrease in at least one Heidelberg Retina Tomograph (HRT) parameter by: Rim Area 0.2 millimeter (mm)2, Rim Volume 0.1 mm3, or mean retinal nerve fiber layer (RNFL) Thickness 0.1 mm, (Last Visit minus Baseline).
Measured: Month 24 (or last visit)
Number of Participants With Individual Progression of Glaucoma Damage: Visual Field Defect-Deterioration
Visual Field Deterioration rated as progressive by physician on at least one post-baseline visit; range: 1= improved 2= stable 3= progressive. If both eyes were treated with Xalatan® the value for the right eye was used; otherwise, only the assessment for the eye treated with study medication was used.
Measured: Month 24 (or last visit)
Number of Participants With Individual Progression of Glaucoma Damage: Aulhorn Stage
Increase in Aulhorn Stage by at least one stage (last visit minus baseline). Three different visual field defect categories defined using Aulhorn stage values 1-5: Aulhorn stage 1 = mild damage, Aulhorn stages 2, 3 = moderate damage, Aulhorn stages 4, 5 =severe damage.
Measured: Month 24 (or last visit)
Number of Participants With Individual Progression of Glaucoma Damage: Mean Defect
Decrease in mean defect by at least 2.5 decibels (dB) (Last Visit minus Baseline).
Measured: Month 24 (or last visit)
Percentage of Participants With Overall Progression of Glaucoma Damage
Overall progression defined as at least 1 of the 6 individual progression of glaucoma damage measures met: increase in horizontal cup to disc ratio and/or vertical cup to disc ratio by at least 0.2; at least 1 post Baseline (BL) optic-disc hemorrhage; decreased rim area (0.2 mm2), rim volume (0.1 mm3), mean retinal nerve fiber layer (RNFL)(0.1 mm), progressive visual field deterioration, increase in Aulhorn stage (by at least 1 stage), and/or decrease in mean defect by at least 2.5 decibels [dB])
Measured: Month 24 (or last visit)
Percentage of Participants With Progression of Optic Disc Excavation
Progression (Last Visit minus Baseline) defined as increase in horizontal cup to disc ratio and/or vertical cup to disc ratio by at least 0.2, and/or decrease in at least 1 of Heidelberg Retina Tomograph (HRT) parameters (deterioration of rim area 0.2 mm2; deterioration of rim volume 0.1 mm3 deterioration or mean retinal nerve fiber layer (RNFL) thickness 0.1 mm).
Measured: Month 24 (or last visit)
Percentage of Participants With Progression of Visual Field
Progression defined as visual field deterioration rated progressive by physician on at least 1 post-baseline visit, and increase in Aulhorn stage (by at least 1 stage) and/or decrease in mean defect by at least 2.5 dB (Last Visit minus Baseline).
Measured: Month 24 (or last visit)

Timeline

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

Aug 2006Sep 2009

First posted27 Sep 2010 (estimated)
Study startAug 2006
Primary completionSep 2009
Study completionSep 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 Low Tension 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: 902 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01209624
Sponsor's protocol ID: A6111135
Other IDs: A6111135
Acronym: NTG-X-PERT
Status last verified: Jun 2011
First submitted: 23 Sep 2010
Last updated: 26 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

Enrolling by invitationPhase 1/2
Topical Insulin for Glaucoma (TING2)
Open Angle Glaucoma, Primary Open Angle Glaucoma
RecruitingObservational study
Dresden Glaucoma and Treatment Study (DGTS)
Glaucoma, Glaucoma, Open-Angle
Active, not recruiting
Direct Selective Laser Trabeculoplasty in Ethnic Chinese Population
Primary Open Angle Glaucoma, Ocular Hypertension
Recruiting
Transcorneal Electrical Stimulation for the Treatment of Visual Field Defects in Patients With Open-Angle Glaucoma
Glaucoma, Primary Open Angle Glaucoma
Not yet recruiting
DSLT in Normal Tension Glaucoma (NTG) Asian Eyes
Normal Tension Glaucoma (NTG), Glaucoma

All Low Tension Glaucoma trials

Study at a glance

From the registry record, last updated by the sponsor on 26 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Prospective, Observational Study to Investigate the Long-term Effect of Xalatan® on Intraocular Pressure (IOP) and on Maintenance of Visual Field in Patients With Normal Tension Glaucoma (NTG)
ClinicalTrials.gov ID: NCT01209624
Acronym / sponsor ID: NTG-X-PERT / A6111135
Conditions: Low Tension Glaucoma
Keywords: prospective, non-interventional, observational, multi-center, long-term
Study type: Observational
Recruitment status: Completed
Enrolment: 902 participants (actual)
Lead sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.Industry (pharma, biotech, devices)
Study start: Aug 2006
Primary completion: Sep 2009 (actual)
Study completion: Sep 2009 (actual)
First posted: 27 Sep 2010 (estimated)
Results: Posted 26 Oct 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

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Glaucoma subjects

Key inclusion criteria (1 listed)

patients with normal-tension glaucoma

Key exclusion criteria (1 listed)

none

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

Change From Baseline in Raw Intraocular Pressure (IOP) by Visit
Time frame: Baseline, Month 6, Month 12, Month 18, Month 24, Last Visit
Mean IOP values measured by applanation tonometry or noncontact method; valid range: 8-40 millimeters of mercury (mmHg). Only the IOP reading for the eye treated with Xalatan® was used; if both eyes were treated, the value of the right eye was analyzed. Last visit = last post-baseline visit at which participant provides a value of IOP.
Number of Participants With a 24-Hour Intraocular Pressure (IOP) Profile: Month 12
Time frame: Month 12
Response: Yes = had an IOP 24-hour profile; No = did not have an IOP 24-hour profile.
Number of Participants With a 24-Hour Intraocular Pressure (IOP) Profile: Month 24
Time frame: Month 24
Response: Yes = had an IOP 24-hour profile; No = did not have an IOP 24-hour profile.
Number of Participants Per Visit With Intraocular Pressure (IOP) 24-Hour Pressure Peaks: Month 12
Time frame: Month 12
Response: Yes = had IOP 24-hour pressure peak; No = did not have IOP 24-hour pressure peak.
Number of Participants Per Visit With Intraocular Pressure (IOP) 24-Hour Pressure Peaks: Month 24
Time frame: Month 24
Response: Yes = had IOP 24-hour pressure peak; No = did not have IOP 24-hour pressure peak.
Percentage of Participants Who Achieved Intraocular Pressure (IOP) Target at Last Visit
Time frame: Month 24, (or last visit)
Percentage of participants who achieved their IOP target set at baseline. Response: Yes = achieved IOP target at last vist; No = did not achieve IOP target at last visit.
Change From Baseline by Visit in Optic Disc Excavation: Horizontal Cup to Disc Ratio
Time frame: Baseline, Month 6, Month 12, Month 18, Month 24, Last Visit
Mean horizontal cup to disc (cup/disc or C/D) ratio measured by slit lamp examination to assess progression of glaucoma; calculated as the ratio of the diameter of the depression (cup) to that of the optical nerve head (disc). Valid range: 0.1-1.0. Only data for the eye treated with Xalatan® was used; if both eyes were treated, the value of the right eye was analyzed.
Change From Baseline by Visit in Optic Disc Excavation: Vertical Cup to Disc Ratio
Time frame: Baseline, Month 6, Month 12, Month 18, Month 24, Last Visit
Mean vertical cup to disc (cup/disc or C/D) ratio measured by slit lamp examination to assess progression of glaucoma; calculated as the ratio of the diameter of the depression (cup) to that of the optical nerve head (disc). Valid range: 0.1-1.0; a high cup/disc ratio may imply glaucoma. Only data for the eye treated with Xalatan® was used; if both eyes were treated, the value of the right eye was analyzed.
Number of Participants With Optic Disc Hemorrhage by Visit: Month 6
Time frame: Month 6
Presence of optic disc hemorrhages assessed by slip lamp examination. Only data for eye were treated with Xalatan® was used; if both eyes were treated, the value of the right eye was analyzed.
Number of Participants With Optic Disc Hemorrhage by Visit: Month 12
Time frame: Month 12
Presence of optic disc hemorrhages assessed by slip lamp examination. Only data for eye were treated with Xalatan® was used; if both eyes were treated, the value of the right eye was analyzed.
Number of Participants With Optic Disc Hemorrhage by Visit: Month 18
Time frame: Month 18
Presence of optic disc hemorrhages assessed by slip lamp examination. Only data for eye were treated with Xalatan® was used; if both eyes were treated, the value of the right eye was analyzed.
Number of Participants With Optic Disc Hemorrhage by Visit: Month 24
Time frame: Month 24
Presence of optic disc hemorrhages assessed by slip lamp examination. Only data for eye were treated with Xalatan® was used; if both eyes were treated, the value of the right eye was analyzed.
Change From Baseline in Heidelberg Retina Tomograph (HRT) Parameters: Rim Area
Time frame: Baseline, Month 6, Month 12, Month 18, Month 24, Last Visit
Rim area (millimeter [mm]2) right and left eye assessed by HRT imaging. Valid range: 0.500 to 1.900 mm2. Only the rim area for the eye treated with Xalatan® was used; if both eyes were treated, the value of the right eye was analyzed.
Change From Baseline in Heidelberg Retina Tomograph (HRT) Parameters: Rim Volume
Time frame: Baseline, Month 6, Month 12, Month 18, Month 24, Last Visit
Rim volume (mm3) right and left eye assessed by HRT imaging. Valid range: 0.080 to 0.700 mm3. Only the rim volume for the eye treated with Xalatan® was used; if both eyes were treated, the value of the right eye was analyzed.
Change From Baseline in Heidelberg Retina Tomograph Parameters: Cup Shape Measure
Time frame: Baseline, Month 6, Month 12, Month 18, Month 24, Last Visit
Cup shape measure right and left eye assessed by HRT imaging . Valid range: -0.400 to -0.010. Only the cup shape measure for the eye treated with Xalatan® was used; if both eyes were treated, the value of the right eye was analyzed.
Change From Baseline in Heidelberg Retina Tomograph (HRT) Parameters: Mean RNFL Thickness
Time frame: Baseline, Month 6, Month 12, Month 18, Month 24, Last Visit
Mean retinal nerve fiber layer (RNFL) thickness in millimeters (mm) right and left eye assessed by HRT imaging. Valid range: 0.100 to 0.400 mm. Only the RNFL for the eye treated with Xalatan® was used; if both eyes were treated, the value of the right eye was analyzed.
Number of Participants With Change From Baseline to Month 24 in Aulhorn Stages
Time frame: Baseline, Month 24
Values of change in Aulhorn Stage measured by Humphrey Visual Field Analyzer. Aulhorn stages: no scotoma, Stage I (relative scotomas only), Stage II (absolute scotomas without connection to blind spot), Stage III (absolute scotomas with connection to blind spot), Stage IV (absolute scotomas more than 1 quadrant affected), and Stage V (temporal residual visual field only). If both eyes were treated with Xalantan® the value of right eye was analyzed; otherwise, only the assessment for the eye treated with study medication was used.
Number of Participants With Change From Baseline to Month 24 in Visual Field Defect
Time frame: Baseline, Month 24
Change in mean defect right and left eye; valid range: -30 - + 30 decibels (dB). Visual field defect categories: preperimetric glaucoma: ≥ -2 dB; mild damage: < -2 dB and ≥ -3.3 dB; moderate damage: < -3.3 dB and ≥ -4.6 dB; and severe damage: < -4.6 dB. If both eyes were treated with Xalatan® , the value for the right eye was used; otherwise, only the mean defect value for the eye treated with study medication was used.
Number of Participants With Investigator Assessments of Efficacy at Month 24
Time frame: Month 24
Number of participants with Investigator assessments of the efficacy of Xalatan® treatment rated as: 1=very good, 2=good, 3=moderate, 4=insufficient. If study medication was stopped before 24 months, assessment was performed at the time of early termination.
Number of Participants With Individual Progression of Glaucoma Damage: Horizontal Cup to Disc Ratio and/or Vertical Cup to Disc Ratio
Time frame: Month 24 (or last visit)
Increase in Horizontal Cup to Disc Ratio and/or Vertical Cup to Disc Ratio by at least 0.2 (Last Visit minus Baseline).
Number of Participants With Individual Progression of Glaucoma Damage: Optic Disc Hemorrhage
Time frame: Month 24 (or last visit)
Participants with at least one post-baseline optic disc hemorrhage.
Number of Participants With Individual Progression of Glaucoma Damage: Rim Area, Rim Volume, or Mean Retinal Nerve Fiber Layer (RNFL) Thickness
Time frame: Month 24 (or last visit)
Decrease in at least one Heidelberg Retina Tomograph (HRT) parameter by: Rim Area 0.2 millimeter (mm)2, Rim Volume 0.1 mm3, or mean retinal nerve fiber layer (RNFL) Thickness 0.1 mm, (Last Visit minus Baseline).
Number of Participants With Individual Progression of Glaucoma Damage: Visual Field Defect-Deterioration
Time frame: Month 24 (or last visit)
Visual Field Deterioration rated as progressive by physician on at least one post-baseline visit; range: 1= improved 2= stable 3= progressive. If both eyes were treated with Xalatan® the value for the right eye was used; otherwise, only the assessment for the eye treated with study medication was used.
Number of Participants With Individual Progression of Glaucoma Damage: Aulhorn Stage
Time frame: Month 24 (or last visit)
Increase in Aulhorn Stage by at least one stage (last visit minus baseline). Three different visual field defect categories defined using Aulhorn stage values 1-5: Aulhorn stage 1 = mild damage, Aulhorn stages 2, 3 = moderate damage, Aulhorn stages 4, 5 =severe damage.
Number of Participants With Individual Progression of Glaucoma Damage: Mean Defect
Time frame: Month 24 (or last visit)
Decrease in mean defect by at least 2.5 decibels (dB) (Last Visit minus Baseline).
Percentage of Participants With Overall Progression of Glaucoma Damage
Time frame: Month 24 (or last visit)
Overall progression defined as at least 1 of the 6 individual progression of glaucoma damage measures met: increase in horizontal cup to disc ratio and/or vertical cup to disc ratio by at least 0.2; at least 1 post Baseline (BL) optic-disc hemorrhage; decreased rim area (0.2 mm2), rim volume (0.1 mm3), mean retinal nerve fiber layer (RNFL)(0.1 mm), progressive visual field deterioration, increase in Aulhorn stage (by at least 1 stage), and/or decrease in mean defect by at least 2.5 decibels [dB])
Percentage of Participants With Progression of Optic Disc Excavation
Time frame: Month 24 (or last visit)
Progression (Last Visit minus Baseline) defined as increase in horizontal cup to disc ratio and/or vertical cup to disc ratio by at least 0.2, and/or decrease in at least 1 of Heidelberg Retina Tomograph (HRT) parameters (deterioration of rim area 0.2 mm2; deterioration of rim volume 0.1 mm3 deterioration or mean retinal nerve fiber layer (RNFL) thickness 0.1 mm).
Percentage of Participants With Progression of Visual Field
Time frame: Month 24 (or last visit)
Progression defined as visual field deterioration rated progressive by physician on at least 1 post-baseline visit, and increase in Aulhorn stage (by at least 1 stage) and/or decrease in mean defect by at least 2.5 dB (Last Visit minus Baseline).

Results and safety

Results posted to the registry on 26 Oct 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
Xalatan®	902	576

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

Time frame: Baseline, Month 6, Month 12, Month 18, Month 24, Last Visit. Mean (Standard Deviation). Unit: mmHg

Measure	Xalatan® n = 469
Month 6	-3.20 (3.11)
Month 12	-3.12 (3.35)
Month 18	-3.22 (3.52)
Month 24	-3.43 (3.51)
Last Visit	-3.34 (3.59)

Population analysed: Per protocol (PP) analysis set: all participants in the Full Analysis Set (at least 1 dose of Xalatan® and 1 post-baseline IOP measurement) who were treated for ≥18 months; had at least BL and 1 post-BL non-missing efficacy assessments for IOP at least 18 months apart; without ametropy at BL; and without additional glaucoma medication during study.

Primary outcome: Number of Participants With a 24-Hour Intraocular Pressure (IOP) Profile: Month 12

Time frame: Month 12. Number. Unit: Participants

Measure	Xalatan® n = 436
Yes	60
No	376

Population analysed: PP; N = number of participants with analyzable data at observation.

Primary outcome: Number of Participants With a 24-Hour Intraocular Pressure (IOP) Profile: Month 24

Time frame: Month 24. Number. Unit: Participants

Measure	Xalatan® n = 423
Yes	56
No	367

Population analysed: PP; N = number of participants with analyzable data at observation.

Primary outcome: Number of Participants Per Visit With Intraocular Pressure (IOP) 24-Hour Pressure Peaks: Month 12

Time frame: Month 12. Number. Unit: Participants

Measure	Xalatan® n = 120
Yes	6
No	114

Population analysed: PP; N = number of participants with analyzable data at observation. The total number of participants by visit with an IOP peak response of 'Yes' differs from those with numerical values of IOP peaks since 1 of the 2 fields was populated for certain participants.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Xalatan®	6 of 902 (0.7%)	24 of 902 (2.7%)	Not reported

Limitations and caveats (from the sponsor): Outcome measures for this observational non-interventional study were not designated as primary or secondary measures.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 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.

Related trials for Low Tension Glaucoma

Enrolling by invitationPhase 1/2
Topical Insulin for Glaucoma (TING2)
Open Angle Glaucoma, Primary Open Angle Glaucoma
RecruitingObservational study
Dresden Glaucoma and Treatment Study (DGTS)
Glaucoma, Glaucoma, Open-Angle
Active, not recruiting
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Recruiting
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Not yet recruiting
DSLT in Normal Tension Glaucoma (NTG) Asian Eyes
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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 Low Tension Glaucoma, 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 26 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 26 Oct 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 Raw Intraocular Pressure (IOP) by Visit (time frame: Baseline, Month 6, Month 12, Month 18, Month 24, Last Visit). The study lists 28 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 NCT01209624.

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 26 Feb 2021.