ABOUT THIS STUDY
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
Pfizer Clinical Trials Contact Center
1-800-718-1021
- Male or female <18 years of age (neonates must be at least 36 weeks gestational age).
- Diagnosis of pediatric glaucoma or elevated intraocular pressure.
- Evidence of a personally signed and dated informed consent document indicating that the subject (and/or a legally acceptable representative) has been informed of all pertinent aspects of the study. A signed and dated assent will be required where applicable according to local laws.
For treated subjects only:
- Continuously treated with latanoprost for at least 1 month within the year prior to the baseline examination.
For untreated subjects only:
- Continuously treated with latanoprost or other topical prostaglandin analogues for less than one month prior to the baseline examination (based on the best knowledge of treating ophthalmologists), and unlikely to be treated with latanoprost or other topical prostaglandin analogues during the three-year study period; OR
- No prior treatment with latanoprost or other topical prostaglandin analogues, and unlikely to be treated with latanoprost or other topical prostaglandin analogues during the three-year study period.
- Unable/unwilling to comply with protocol.
- Pregnant or nursing females at baseline.
- For treated subjects only: a history of allergy or hypersensitivity to any of the
ingredients contained in latanoprost (e.g., hypersensitivity to benzalkonium
chloride).
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Descriptive Information | ||||
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Brief Title | Long-Term Non-Interventional Latanoprost Study | |||
Official Title | A Prospective, Non-interventional, Longitudinal Cohort Study To Evaluate The Long-term Safety Of Latanoprost Treatment In Pediatric Populations | |||
Brief Summary | This is a non-interventional, prospective, longitudinal cohort study. A total of 150 pediatric subjects with glaucoma or elevated intraocular pressure, including 75 latanoprost-treated subjects and 75 non-topical prostaglandin analogue treated subjects, will be enrolled from ophthalmic hospital clinics and academic ophthalmic centers. As a non-interventional study, the study subjects' continued use of latanoprost and assessments of ocular events will be obtained through the routine medical follow-up with treating ophthalmologists or other designated members of the medical care team. | |||
Detailed Description | At least 40 subjects in each of the following age groups: 1-<5 years and 5-<18 years. No minimum required numbers in the <1 year age group. | |||
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 | Pediatric populations diagnosed with glaucoma or elevated intraocular pressure | |||
Condition |
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Intervention |
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Study Groups/Cohorts |
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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 | 175 | |||
Original Estimated Enrollment | 200 | |||
Actual Study Completion Date | February 2016 | |||
Actual Primary Completion Date | February 2016 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria | Inclusion Criteria:
For treated subjects only:
For untreated subjects only:
Exclusion Criteria:
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Sex/Gender |
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Ages | up to 17 Years (Child) | |||
Accepts Healthy Volunteers | No | |||
Contacts | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries | Belgium, Colombia, Czechia, Denmark, France, Germany, Greece, Italy, Peru, Portugal, Slovakia, Spain, Sweden, United Kingdom | |||
Removed Location Countries | Czech Republic | |||
Administrative Information | ||||
NCT Number | NCT01265719 | |||
Other Study ID Numbers | A6111143 PFI-LAT-2009-01 ( Other Identifier: Alias Study Number ) LYNX ( Other Identifier: Other identifier ) | |||
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 |
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PRS Account | Pfizer | |||
Verification Date | February 2018 |