Long-Term Non-Interventional Latanoprost Study

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NCT01265719

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Study Location
Universitair Ziekenhuis Antwerpen, Dienst Oftalmologie
Edegem, , 2650, Belgium
See other locations
Contact
1-800-718-1021
[email protected]
Related Links

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

By email

Contact

[email protected]

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Glaucoma, Ocular Hypertension
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
0-17
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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.

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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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Advanced Information
Descriptive Information
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
  • Glaucoma
  • Ocular Hypertension
Intervention
  • Other: No intervention other than routine medical care
    Subjects continuously treated with Latanoprost for at least one month Latanoprost treatment during the study period.
    Other Name: Observational
  • Other: No intervention other than routine medical care
    Subjects not treated with any topical prostaglandin analogues or continuously treated with topical prostaglandin analogues for less than one month before the baseline examination, and unlikely to be treated with topical prostaglandin analogues during the study period.
    Other Name: Observational
Study Groups/Cohorts
  • Latanoprost-treatment group
    Intervention: Other: No intervention other than routine medical care
  • Non-topical prostaglandin analogue treatment group
    Intervention: Other: No intervention other than routine medical care
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
 (submitted: February 19, 2018)		175
Original Estimated Enrollment
 (submitted: December 21, 2010)		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:

  • 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.

Exclusion Criteria:

  • 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).
Sex/Gender
Sexes Eligible for Study:All
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
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date February 2018