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

Low Tension Glaucoma Clinical Trial

— NTG-X-PERT  

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01209624
• Other study ID #: A6111135
• Secondary ID: A6111135
• Status: Completed
• Start date: August 2006
• Est. completion date: September 2009

Study information

• Verified date: June 2011
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 902
• Est. completion date: September 2009
• Est. primary completion date: September 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

patients with normal-tension glaucoma Exclusion Criteria: none

Related Conditions & MeSH terms

• Glaucoma
• Low Tension Glaucoma

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline, Month 6, Month 12, Month 18, Month 24, Last Visit
Primary	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.	Month 12
Primary	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.	Month 24
Primary	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.	Month 12
Primary	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.	Month 24
Primary	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.	Month 24, (or last visit)
Primary	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.	Baseline, Month 6, Month 12, Month 18, Month 24, Last Visit
Primary	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.	Baseline, Month 6, Month 12, Month 18, Month 24, Last Visit
Primary	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.	Month 6
Primary	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.	Month 12
Primary	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.	Month 18
Primary	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.	Month 24
Primary	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.	Baseline, Month 6, Month 12, Month 18, Month 24, Last Visit
Primary	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.	Baseline, Month 6, Month 12, Month 18, Month 24, Last Visit
Primary	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.	Baseline, Month 6, Month 12, Month 18, Month 24, Last Visit
Primary	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.	Baseline, Month 6, Month 12, Month 18, Month 24, Last Visit
Primary	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.	Baseline, Month 24
Primary	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.	Baseline, Month 24
Primary	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.	Month 24
Primary	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).	Month 24 (or last visit)
Primary	Number of Participants With Individual Progression of Glaucoma Damage: Optic Disc Hemorrhage	Participants with at least one post-baseline optic disc hemorrhage.	Month 24 (or last visit)
Primary	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).	Month 24 (or last visit)
Primary	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.	Month 24 (or last visit)
Primary	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.	Month 24 (or last visit)
Primary	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).	Month 24 (or last visit)
Primary	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])	Month 24 (or last visit)
Primary	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).	Month 24 (or last visit)
Primary	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).	Month 24 (or last visit)

External Links

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