Observational Study of the Long-term Effect of Latanoprost in Normal Tension Glaucoma (NTG-X-PERT)

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT01209624
First received: September 23, 2010
Last updated: July 7, 2011
Last verified: June 2011
  Purpose

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. Intraocular pressure (IOP), optic nerve head findings, visual field status, and adverse events were recorded.


Condition Phase
Low Tension Glaucoma
Phase 4

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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)

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Change From Baseline in Raw Intraocular Pressure (IOP) by Visit [ Time Frame: Baseline, Month 6, Month 12, Month 18, Month 24, Last Visit ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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).


Enrollment: 902
Study Start Date: August 2006
Study Completion Date: September 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Glaucoma subjects

Criteria

Inclusion Criteria:

patients with normal-tension glaucoma

Exclusion Criteria:

none

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01209624

Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT01209624     History of Changes
Other Study ID Numbers: A6111135, A6111135
Study First Received: September 23, 2010
Results First Received: September 29, 2010
Last Updated: July 7, 2011
Health Authority: Germany: Bundesinstitut für Arzneimittel und Medizinprodukte Bonn

Keywords provided by Pfizer:
prospective
non-interventional
observational
multi-center
long-term

Additional relevant MeSH terms:
Glaucoma
Low Tension Glaucoma
Ocular Hypertension
Eye Diseases
Optic Nerve Diseases

ClinicalTrials.gov processed this record on August 28, 2014