Clinical trial NCT01209624: Observational Study of the Long-term Effect of Latanoprost in Normal Tension Glaucoma
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)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Low Tension Glaucoma
Keywords: prospective
non-interventional
observational
multi-center
long-term
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2010-09-27
Enrollment: 902
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Glaucoma subjects

Brief 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.


Eligibility criteria: Inclusion Criteria:

patients with normal-tension glaucoma

Exclusion Criteria:

none

Primary outcomes:
measure: Change From Baseline in Raw Intraocular Pressure (IOP) by Visit
timeFrame: Baseline, Month 6, Month 12, Month 18, Month 24, Last Visit
measure: Number of Participants With a 24-Hour Intraocular Pressure (IOP) Profile: Month 12
timeFrame: Month 12
measure: Number of Participants With a 24-Hour Intraocular Pressure (IOP) Profile: Month 24
timeFrame: Month 24
measure: Number of Participants Per Visit With Intraocular Pressure (IOP) 24-Hour Pressure Peaks: Month 12
timeFrame: Month 12
measure: Number of Participants Per Visit With Intraocular Pressure (IOP) 24-Hour Pressure Peaks: Month 24
timeFrame: Month 24
measure: Percentage of Participants Who Achieved Intraocular Pressure (IOP) Target at Last Visit
timeFrame: Month 24, (or last visit)
measure: Change From Baseline by Visit in Optic Disc Excavation: Horizontal Cup to Disc Ratio
timeFrame: Baseline, Month 6, Month 12, Month 18, Month 24, Last Visit
measure: Change From Baseline by Visit in Optic Disc Excavation: Vertical Cup to Disc Ratio
timeFrame: Baseline, Month 6, Month 12, Month 18, Month 24, Last Visit
measure: Number of Participants With Optic Disc Hemorrhage by Visit: Month 6
timeFrame: Month 6
measure: Number of Participants With Optic Disc Hemorrhage by Visit: Month 12
timeFrame: Month 12
measure: Number of Participants With Optic Disc Hemorrhage by Visit: Month 18
timeFrame: Month 18
measure: Number of Participants With Optic Disc Hemorrhage by Visit: Month 24
timeFrame: Month 24
measure: Change From Baseline in Heidelberg Retina Tomograph (HRT) Parameters: Rim Area
timeFrame: Baseline, Month 6, Month 12, Month 18, Month 24, Last Visit
measure: Change From Baseline in Heidelberg Retina Tomograph (HRT) Parameters: Rim Volume
timeFrame: Baseline, Month 6, Month 12, Month 18, Month 24, Last Visit
measure: Change From Baseline in Heidelberg Retina Tomograph Parameters: Cup Shape Measure
timeFrame: Baseline, Month 6, Month 12, Month 18, Month 24, Last Visit
measure: Change From Baseline in Heidelberg Retina Tomograph (HRT) Parameters: Mean RNFL Thickness
timeFrame: Baseline, Month 6, Month 12, Month 18, Month 24, Last Visit
measure: Number of Participants With Change From Baseline to Month 24 in Aulhorn Stages
timeFrame: Baseline, Month 24
measure: Number of Participants With Change From Baseline to Month 24 in Visual Field Defect
timeFrame: Baseline, Month 24
measure: Number of Participants With Investigator Assessments of Efficacy at Month 24
timeFrame: Month 24
measure: Number of Participants With Individual Progression of Glaucoma Damage: Horizontal Cup to Disc Ratio and/or Vertical Cup to Disc Ratio
timeFrame: Month 24 (or last visit)
measure: Number of Participants With Individual Progression of Glaucoma Damage: Optic Disc Hemorrhage
timeFrame: Month 24 (or last visit)
measure: Number of Participants With Individual Progression of Glaucoma Damage: Rim Area, Rim Volume, or Mean Retinal Nerve Fiber Layer (RNFL) Thickness
timeFrame: Month 24 (or last visit)
measure: Number of Participants With Individual Progression of Glaucoma Damage: Visual Field Defect-Deterioration
timeFrame: Month 24 (or last visit)
measure: Number of Participants With Individual Progression of Glaucoma Damage: Aulhorn Stage
timeFrame: Month 24 (or last visit)
measure: Number of Participants With Individual Progression of Glaucoma Damage: Mean Defect
timeFrame: Month 24 (or last visit)
measure: Percentage of Participants With Overall Progression of Glaucoma Damage
timeFrame: Month 24 (or last visit)
measure: Percentage of Participants With Progression of Optic Disc Excavation
timeFrame: Month 24 (or last visit)
measure: Percentage of Participants With Progression of Visual Field
timeFrame: Month 24 (or last visit)
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: