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| ID | Type | Description | Link |
|---|---|---|---|
| A6111135 |
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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.
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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. |
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Inclusion Criteria:
patients with normal-tension glaucoma
Exclusion Criteria:
none
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Glaucoma subjects
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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In this prospective non-interventional study, participants did not actively participate in the study but were observed in general clinical practice by office-based ophthalmologists.
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| ID | Title | Description |
|---|---|---|
| FG000 | Xalatan® | Once daily as 1 drop (topical application) in the evening |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Xalatan® | Once daily as 1 drop (topical application) in the evening |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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. | Posted | Mean | Standard Deviation | mmHg | Baseline, Month 6, Month 12, Month 18, Month 24, Last Visit |
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Safety population: all subjects who received at least 1 dose of study medication. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Xalatan® | Once daily as 1 drop (topical application) in the evening |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Myocardial infarction | Cardiac disorders | MedDRA 12.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Angina pectoris | Cardiac disorders | MedDRA 12.1 | Systematic Assessment |
Outcome measures for this observational non-interventional study were not designated as primary or secondary measures.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
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| ID | Term |
|---|---|
| D057066 | Low Tension Glaucoma |
| ID | Term |
|---|---|
| D005901 | Glaucoma |
| D009798 | Ocular Hypertension |
| D005128 | Eye Diseases |
| D009901 | Optic Nerve Diseases |
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| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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). | 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. | 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). | 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. | 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. | 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). | 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]) | 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). | 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). | Month 24 (or last visit) |
| Lost to Follow-up |
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| Other |
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| participants |
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| Sex/Gender, Customized | Number | participants |
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| Raw Intraocular Pressure | Mean IOP value 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. Participants may represented in more than 1 category. Results based on participants in PP population with a non-missing response at baseline. | Mean | Standard Deviation | mmHg |
|
| Horizontal Cup to Disc Ratio | Mean horizontal cup to disc 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. Participants may be represented in more than 1 category. Results based on participants in PP population with a non-missing response at baseline. | Mean | Standard Deviation | Ratio |
|
| Vertical Cup to Disc Ratio | Mean vertical cup to disc 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. Participants may be represented in more than 1 category. Results based on participants in PP population with a non-missing response at baseline. | Mean | Standard Deviation | Ratio |
|
| 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. Participants may represent more than 1 category. Results based on participants in PP population with a non-missing response at baseline. | Mean | Standard Deviation | mm^2 |
|
| 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. Participants may be represented in more than 1 category. Results based on participants in PP population with a non-missing response at baseline. | Mean | Standard Deviation | mm^3 |
|
| 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. Participants may be represented in more than 1 category. Results based on participants in PP population with a non-missing response at baseline. | Mean | Standard Deviation | Cup shape measure |
|
| Retinal Nerve Fiber Layer 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. Participants may be represented in more than 1 category. Results based on participants in PP population with a non-missing response at baseline. | Mean | Standard Deviation | mm |
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| Optic Disc Hemorrhage | 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. Participants may be represented in more than 1 category. Results based on participants in PP population with a non-missing response at baseline. | Number | Participants |
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| 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. | PP; N = number of participants with analyzable data at observation. | Posted | Number | Participants | Month 12 |
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| 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. | PP; N = number of participants with analyzable data at observation. | Posted | Number | Participants | Month 24 |
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| 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. | 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. | Posted | Number | Participants | Month 12 |
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| 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. | 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. | Posted | Number | Participants | Month 24 |
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| 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. | PP; n = number of subjects in the Per Protocol Analysis Set with a non-missing response at Last Visit. Last visit = last post-baseline visit at which participant provides a value of IOP. | Posted | Number | Percentage of Participants | Month 24, (or last visit) |
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| 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. | PP; N = number of participants with horizontal cup to disc ratio data at baseline and at least 1 post-baseline visit; change analyzed for participants with a non-missing response at baseline and observation. Last Visit: change in participants with a non-missing response at both baseline and at least one post-baseline visit. | Posted | Mean | Standard Deviation | Ratio | Baseline, Month 6, Month 12, Month 18, Month 24, Last Visit |
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| 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. | PP. N = number of participants with vertical cup to disc ratio at baseline and at least 1 post-baseline visit; change analyzed for participants with a non-missing response at baseline and observation. Last Visit: change in vertical cup to disc ratio in participants with a non-missing response at both baseline and at least one post-baseline visit. | Posted | Mean | Standard Deviation | Ratio | Baseline, Month 6, Month 12, Month 18, Month 24, Last Visit |
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| 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. | PP; N = number of participants who indicated whether or not they had an optic disc hemorrhage at the given visit. | Posted | Number | Participants | Month 6 |
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| 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. | PP; N = number of participants who indicated whether or not they had an optic disc hemorrhage at the given visit. | Posted | Number | Participants | Month 12 |
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| 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. | PP; N = number of participants who indicated whether or not they had an optic disc hemorrhage at the given visit. | Posted | Number | Participants | Month 18 |
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| 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. | PP; N = number of participants who indicated whether or not they had an optic disc hemorrhage at the given visit. | Posted | Number | Participants | Month 24 |
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| 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. | PP; n = number of participants with a non-missing response at both visits (baseline and observation). Last Visit = last post-baseline visit at which participant provides a value for rim area. | Posted | Mean | Standard Deviation | mm2 | Baseline, Month 6, Month 12, Month 18, Month 24, Last Visit |
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| 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. | PP; n = number of participants with a non-missing response at both visits (baseline and observation). Last Visit = last post-baseline visit at which participant provides a value for rim volume. | Posted | Mean | Standard Deviation | mm3 | Baseline, Month 6, Month 12, Month 18, Month 24, Last Visit |
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| 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. | PP; n = number of participants with a non-missing response at both visits (baseline and observation). Last Visit = last post-baseline visit at which participant provides a value for cup shape measure. | Posted | Mean | Standard Deviation | Cup shape measure | Baseline, Month 6, Month 12, Month 18, Month 24, Last Visit |
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| 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. | PP; n = number of participants with a non-missing response at both visits (baseline and observation). Last Visit = last post-baseline visit at which participant provides a value for RNFL thickness. | Posted | Mean | Standard Deviation | mm | Baseline, Month 6, Month 12, Month 18, Month 24, Last Visit |
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| 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. | PP; N = number of participants who provided Aulhorn stage values of 1 to 5 at both baseline and month 24 visits. | Posted | Number | Participants | Baseline, Month 24 |
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| 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. | PP; N = number of participants who provided a Mean Defect value at both Baseline and Month 24 visits. | Posted | Number | Participants | Baseline, Month 24 |
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| 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. | PP; N = number of participants with a non-missing response at Month 24 visit. | Posted | Number | Participants | Month 24 |
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| 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). | PP; results based on participants with both a Baseline and at least one post-baseline visit. Last Visit = last post-baseline visit at which participant provides a value for the relevant outcome measure. | Posted | Number | Participants | Month 24 (or last visit) |
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| Primary | Number of Participants With Individual Progression of Glaucoma Damage: Optic Disc Hemorrhage | Participants with at least one post-baseline optic disc hemorrhage. | PP; results based on participants with at least one post-baseline assessment of optic disc hemorrhage. Last Visit = last post-baseline visit at which participant provides a value for the relevant outcome measure. | Posted | Number | Particpants | Month 24 (or last visit) |
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| 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). | PP; results based on participants with a value of the variable in question at both Baseline and at least one post-baseline visit. Last Visit = last post-baseline visit at which participant provides a value for the relevant outcome measure. | Posted | Number | Participants | Month 24 (or last visit) |
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| 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. | PP; results based on participants with at least one post-baseline assessment of change in visual field defect. Last Visit = last post-baseline visit at which participant provides a value for the relevant outcome measure. | Posted | Number | Participants | Month 24 (or last visit) |
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| 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. | PP; results based on participants with a value for Aulhorn Stage at both Baseline and at least one post-baseline visit. Last Visit = last post-baseline visit at which participant provides a value for the relevant outcome measure. | Posted | Number | Participants | Month 24 (or last visit) |
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| 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). | PP; results based on participants with a value for mean defect at both Baseline and at least one post-baseline visit. Last Visit = last post-baseline visit at which participant provides a value for the relevant outcome measure. | Posted | Number | Participants | 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]) | PP; to be included in the percentage, participants must have provided a response for at least one of the six individual progression of glaucoma damage measures. Last Visit = last post-baseline visit at which participant provides a value for the relevant outcome measure. | Posted | Number | Percentage of Participants | 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). | PP; to be included in the percentage, participants must have provided a response for at least one of following events: increase in horizontal or vertical cup to disc ratio, or decrease in rim area, rim volume, or mean RNFL thickness. Last Visit = last post-baseline visit at which participant provides a value for the relevant outcome measure. | Posted | Number | Percentage of Participants | 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). | PP; to be included in the percentage, participants must have had Visual Field Deterioration rated as progressive by the physician on at least 1 post-baseline visit, and at least one measure of increase in Aulhorn Stage by at least 1 stage, and decrease in Mean Defect by at least 2 dB (last visit minus baseline). | Posted | Number | Percentage of Participants | Month 24 (or last visit) |
|
|
|
| 6 |
| 902 |
| 24 |
| 902 |
| Intestinal obstruction | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Herpes zoster | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
|
| Lung neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.1 | Systematic Assessment |
|
| Cerebrovascular accident | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
|
| Dementia | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
|
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Vertigo | Ear and labyrinth disorders | MedDRA 12.1 | Systematic Assessment |
|
| Conjunctival irritation | Eye disorders | MedDRA 12.1 | Systematic Assessment |
|
| Conjunctivitis | Eye disorders | MedDRA 12.1 | Systematic Assessment |
|
| Conjunctivitis allergic | Eye disorders | MedDRA 12.1 | Systematic Assessment |
|
| Diplopia | Eye disorders | MedDRA 12.1 | Systematic Assessment |
|
| Eye irritation | Eye disorders | MedDRA 12.1 | Systematic Assessment |
|
| Glaucoma | Eye disorders | MedDRA 12.1 | Systematic Assessment |
|
| Ill-defined disorder | General disorders | MedDRA 12.1 | Systematic Assessment |
|
| Drug hypersensitivity | Immune system disorders | MedDRA 12.1 | Systematic Assessment |
|
| Hypersensitivity | Immune system disorders | MedDRA 12.1 | Systematic Assessment |
|
| Seasonal allergy | Immune system disorders | MedDRA 12.1 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
|
| Trigeminal nerve paresis | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 12.1 | Systematic Assessment |
|
| Rash macular | Skin and subcutaneous tissue disorders | MedDRA 12.1 | Systematic Assessment |
|
| Cataract operation | Surgical and medical procedures | MedDRA 12.1 | Systematic Assessment |
|
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| Title | Measurements |
|---|---|
|
| Month 24 |
|
| Last Visit |
|
| Title | Measurements |
|---|---|
|
| Month 24 |
|
| Last Visit |
|
| Title | Measurements |
|---|---|
|
| Month 24 (n = 70) |
|
| Last Visit (n = 111) |
|
| Title | Measurements |
|---|---|
|
| Month 24 (n = 70) |
|
| Last Visit (n = 112) |
|
| Title | Measurements |
|---|---|
|
| Month 24 (n = 71) |
|
| Last Visit (n = 113) |
|
| Title | Measurements |
|---|---|
|
| Month 24 (n = 69) |
|
| Last Visit (n = 110) |
|
| Title | Measurements |
|---|---|
|
| Change in Aulhorn Stage: -1 |
|
| Change in Aulhorn Stage: 0 |
|
| Change in Aulhorn Stage: +1 |
|
| Change in Aulhorn Stage: +2 |
|
| Change in Aulhorn Stage: +3 |
|
| Change in Aulhorn Stage: +4 |
|
| Title | Measurements |
|---|---|
|
| Change in mean defect: ≥ 1.5dB to < 2.5dB |
|
| Change in mean defect: ≥ 2.5dB to < 3.5dB |
|
| Change in mean defect: ≥ 3.5dB to < 4.5dB |
|
| Change in mean defect: ≥ 4.5dB |
|
| Title | Measurements |
|---|
|
| Insufficient |
|