Observational Study of the Long-term Effect of Latanoprost in Normal Tension Glaucoma
NCT01209624
Last updated date
ABOUT THIS STUDY
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.
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
By phone
Pfizer Clinical Trials Contact Center
1-800-718-1021
Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Low Tension Glaucoma
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details
patients with normal-tension glaucoma
Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details
none
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Low Tension GlaucomaObservational Study of the Long-term Effect of Latanoprost in Normal Tension Glaucoma
NCT01209624
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
| Descriptive Information | ||||
|---|---|---|---|---|
| Brief Title | 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) | |||
| 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. | |||
| Detailed Description | Not Provided | |||
| Study Type | Observational | |||
| Study Design | Observational Model: Cohort Time Perspective: Prospective | |||
| Target Follow-Up Duration | Not Provided | |||
| Biospecimen | Not Provided | |||
| Sampling Method | Non-Probability Sample | |||
| Study Population | Glaucoma subjects | |||
| Condition | Low Tension Glaucoma | |||
| Intervention | Not Provided | |||
| Study Groups/Cohorts | Not Provided | |||
| Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
| Recruitment Information | ||||
| Recruitment Status | Completed | |||
| Actual Enrollment | 902 | |||
| Original Actual Enrollment | Same as current | |||
| Actual Study Completion Date | September 2009 | |||
| Actual Primary Completion Date | September 2009 (Final data collection date for primary outcome measure) | |||
| Eligibility Criteria | Inclusion Criteria: patients with normal-tension glaucoma Exclusion Criteria: none | |||
| Sex/Gender |
| |||
| Ages | 18 Years and older (Adult, Older Adult) | |||
| Accepts Healthy Volunteers | No | |||
| Contacts | Contact information is only displayed when the study is recruiting subjects | |||
| Listed Location Countries | Not Provided | |||
| Removed Location Countries | ||||
| Administrative Information | ||||
| NCT Number | NCT01209624 | |||
| Other Study ID Numbers | A6111135 A6111135 | |||
| Has Data Monitoring Committee | No | |||
| U.S. FDA-regulated Product | Not Provided | |||
| IPD Sharing Statement | Not Provided | |||
| Responsible Party | Pfizer ( Pfizer's Upjohn has merged with Mylan to form Viatris Inc. ) | |||
| Study Sponsor | Pfizer's Upjohn has merged with Mylan to form Viatris Inc. | |||
| Collaborators | Not Provided | |||
| Investigators |
| |||
| PRS Account | Pfizer | |||
| Verification Date | June 2011 | |||