N/A
N=902
Observational Study of the Long-term Effect of Latanoprost in Normal Tension Glaucoma
Low Tension Glaucoma
Bottom Line
View on ClinicalTrials.gov: NCT01209624 ↗Enrolled (actual)
902
Serious AEs
0.7%
Results posted
Oct 2010
Primary outcome: Primary: Change From Baseline in Raw Intraocular Pressure (IOP) by Visit — -3.20; -3.12; -3.22; -3.43 mmHg
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- Primary completion
- Sep 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Raw Intraocular Pressure (IOP) by Visit |
-3.20; -3.12; -3.22; -3.43; -3.34 | — |
| PRIMARY Number of Participants With a 24-Hour Intraocular Pressure (IOP) Profile: Month 12 |
60; 376 | — |
| PRIMARY Number of Participants With a 24-Hour Intraocular Pressure (IOP) Profile: Month 24 |
56; 367 | — |
| PRIMARY Number of Participants Per Visit With Intraocular Pressure (IOP) 24-Hour Pressure Peaks: Month 12 |
6; 114 | — |
| PRIMARY Number of Participants Per Visit With Intraocular Pressure (IOP) 24-Hour Pressure Peaks: Month 24 |
6; 101 | — |
| PRIMARY Percentage of Participants Who Achieved Intraocular Pressure (IOP) Target at Last Visit |
56.3; 13.2 | — |
| PRIMARY Change From Baseline by Visit in Optic Disc Excavation: Horizontal Cup to Disc Ratio |
-0.00; 0.00; 0.01; 0.01; 0.00 | — |
| PRIMARY Change From Baseline by Visit in Optic Disc Excavation: Vertical Cup to Disc Ratio |
0.01; 0.01; 0.00; 0.01; 0.00 | — |
| PRIMARY Number of Participants With Optic Disc Hemorrhage by Visit: Month 6 |
7 | — |
| PRIMARY Number of Participants With Optic Disc Hemorrhage by Visit: Month 12 |
6 | — |
| PRIMARY Number of Participants With Optic Disc Hemorrhage by Visit: Month 18 |
9 | — |
| PRIMARY Number of Participants With Optic Disc Hemorrhage by Visit: Month 24 |
5 | — |
| PRIMARY Change From Baseline in Heidelberg Retina Tomograph (HRT) Parameters: Rim Area |
-0.01; -0.01; -0.02; -0.03; -0.02 | — |
| PRIMARY Change From Baseline in Heidelberg Retina Tomograph (HRT) Parameters: Rim Volume |
0.01; 0.00; 0.01; -0.00; 0.00 | — |
| PRIMARY Change From Baseline in Heidelberg Retina Tomograph Parameters: Cup Shape Measure |
-0.00; -0.00; -0.00; -0.01; -0.00 | — |
| PRIMARY Change From Baseline in Heidelberg Retina Tomograph (HRT) Parameters: Mean RNFL Thickness |
-0.00; -0.01; -0.00; 0.00; 0.00 | — |
| PRIMARY Number of Participants With Change From Baseline to Month 24 in Aulhorn Stages |
1; 2; 0; 6; 45; 6 | — |
| PRIMARY Number of Participants With Change From Baseline to Month 24 in Visual Field Defect |
60; 31; 17; 12; 6; 5 | — |
| PRIMARY Number of Participants With Investigator Assessments of Efficacy at Month 24 |
269; 147; 24; 2 | — |
| PRIMARY Number of Participants With Individual Progression of Glaucoma Damage: Horizontal Cup to Disc Ratio and/or Vertical Cup to Disc Ratio |
34 | — |
| PRIMARY Number of Participants With Individual Progression of Glaucoma Damage: Optic Disc Hemorrhage |
16 | — |
| PRIMARY Number of Participants With Individual Progression of Glaucoma Damage: Rim Area, Rim Volume, or Mean Retinal Nerve Fiber Layer (RNFL) Thickness |
12 | — |
| PRIMARY Number of Participants With Individual Progression of Glaucoma Damage: Visual Field Defect-Deterioration |
51 | — |
| PRIMARY Number of Participants With Individual Progression of Glaucoma Damage: Aulhorn Stage |
20 | — |
| PRIMARY Number of Participants With Individual Progression of Glaucoma Damage: Mean Defect |
28 | — |
| PRIMARY Percentage of Participants With Overall Progression of Glaucoma Damage |
25.8 | — |
| PRIMARY Percentage of Participants With Progression of Optic Disc Excavation |
11.3 | — |
| PRIMARY Percentage of Participants With Progression of Visual Field |
3.1 | — |
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
Data sourced from ClinicalTrials.gov (NCT01209624). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.