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Long-Term Non-Interventional Latanoprost Study

Last updated on April 11, 2018

FOR MORE INFORMATION
Study Location
Universitair Ziekenhuis Antwerpen, Dienst Oftalmologie
Edegem, , 2650 Belgium
Contact
1-800-718-1021
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

- 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).

NCT01265719
Pfizer
Completed
Long-Term Non-Interventional Latanoprost Study

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Long-Term Non-Interventional Latanoprost Study
A Prospective, Non-interventional, Longitudinal Cohort Study To Evaluate The Long-term Safety Of Latanoprost Treatment In Pediatric Populations
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.
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.
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample
Pediatric populations diagnosed with glaucoma or elevated intraocular pressure
  • Glaucoma
  • Ocular Hypertension
  • 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
  • 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
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
178
March 2016
March 2016   (Final data collection date for primary outcome measure)

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).
Sexes Eligible for Study: All
up to 17 Years   (Child)
No
Contact information is only displayed when the study is recruiting subjects
Belgium,   Colombia,   Czech Republic,   Denmark,   France,   Germany,   Greece,   Italy,   Peru,   Portugal,   Slovakia,   Spain,   Sweden,   United Kingdom
 
 
NCT01265719
A6111143
LYNX ( Other Identifier: Alias Study Number )
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
May 2016

FOR MORE INFORMATION

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