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

NCT01209624 | Completed Results

• 1 other identifier: A6111135
• Study Type: observational
• Target: 902
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Low Tension Glaucoma

Keywords

prospective; non-interventional; observational; multi-center; long-term

Outcome Measures

Primary Outcomes (28)

• 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.

  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)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Glaucoma subjects

You may qualify if:

• patients with normal-tension glaucoma

You may not qualify if:

• none

Sponsors & Collaborators

• Pfizer's Upjohn has merged with Mylan to form Viatris Inc.: lead

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Low Tension Glaucoma

Condition Hierarchy (Ancestors)

Glaucoma; Ocular Hypertension; Eye Diseases; Optic Nerve Diseases

Limitations and Caveats

Outcome measures for this observational non-interventional study were not designated as primary or secondary measures.

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 23, 2010
• First Posted: September 27, 2010
• Study Start: August 1, 2006
• Primary Completion: September 1, 2009
• Study Completion: September 1, 2009
• Last Updated: February 26, 2021
• Results First Posted: October 26, 2010

Record last verified: 2011-06