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Long-Term Non-Interventional Latanoprost Study (LYNX)

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ClinicalTrials.gov Identifier: NCT01265719
Recruitment Status : Completed
First Posted : December 23, 2010
Last Update Posted : May 13, 2016
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Description
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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.

Condition or disease Intervention/treatment
Glaucoma Ocular Hypertension Other: No intervention other than routine medical care

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 Design
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Study Type : Observational
Actual Enrollment : 178 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Prospective, Non-interventional, Longitudinal Cohort Study To Evaluate The Long-term Safety Of Latanoprost Treatment In Pediatric Populations
Study Start Date : December 2010
Actual Primary Completion Date : March 2016
Actual Study Completion Date : March 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Latanoprost
U.S. FDA Resources

Groups and Cohorts
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Group/Cohort Intervention/treatment
Latanoprost-treatment group 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
Non-topical prostaglandin analogue treatment group 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


Outcome Measures
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Primary Outcome Measures :
  1. Best Corrected Visual Acuity (Snellen or equivalent) [ Time Frame: baseline ]
  2. Best Corrected Visual Acuity (Snellen or equivalent) [ Time Frame: 6 months ]
  3. Best Corrected Visual Acuity (Snellen or equivalent) [ Time Frame: 12 months ]
  4. Best Corrected Visual Acuity (Snellen or equivalent) [ Time Frame: 24 months ]
  5. Best Corrected Visual Acuity (Snellen or equivalent) [ Time Frame: 36 months ]

Secondary Outcome Measures :
  1. Refractive error [ Time Frame: baseline ]
  2. Refractive error [ Time Frame: 6 months ]
  3. Refractive error [ Time Frame: 12 months ]
  4. Refractive error [ Time Frame: 24 months ]
  5. Refractive error [ Time Frame: 36 months ]
  6. Horizontal corneal diameter [ Time Frame: baseline ]
  7. Horizontal corneal diameter [ Time Frame: 6 months ]
  8. Horizontal corneal diameter [ Time Frame: 12 months ]
  9. Horizontal corneal diameter [ Time Frame: 24 months ]
  10. Horizontal corneal diameter [ Time Frame: 36 months ]
  11. Intraocular pressure [ Time Frame: baseline ]
  12. Intraocular pressure [ Time Frame: 6 months ]
  13. Intraocular pressure [ Time Frame: 12 months ]
  14. Intraocular pressure [ Time Frame: 24 months ]
  15. Intraocular pressure [ Time Frame: 36 months ]
  16. Optic nerve changes/structures [ Time Frame: baseline ]
  17. Optic nerve changes/structures [ Time Frame: 6 months ]
  18. Optic nerve changes/structures [ Time Frame: 12 months ]
  19. Optic nerve changes/structures [ Time Frame: 24 months ]
  20. Optic nerve changes/structures [ Time Frame: 36 months ]
  21. Visual field [ Time Frame: baseline ]
  22. Visual field [ Time Frame: 6 months ]
  23. Visual field [ Time Frame: 12 months ]
  24. Visual field [ Time Frame: 24 months ]
  25. Visual field [ Time Frame: 36 months ]
  26. Iris color darkening [ Time Frame: baseline ]
  27. Iris color darkening [ Time Frame: 6 months ]
  28. Iris color darkening [ Time Frame: 12 months ]
  29. Iris color darkening [ Time Frame: 24 months ]
  30. Iris color darkening [ Time Frame: 36 months ]
  31. Localized pigmentation (nevi or freckles) of conjunctiva, iris and choroid [ Time Frame: baseline ]
  32. Localized pigmentation (nevi or freckles) of conjunctiva, iris and choroid [ Time Frame: 6 months ]
  33. Localized pigmentation (nevi or freckles) of conjunctiva, iris and choroid [ Time Frame: 12 months ]
  34. Localized pigmentation (nevi or freckles) of conjunctiva, iris and choroid [ Time Frame: 24 months ]
  35. Localized pigmentation (nevi or freckles) of conjunctiva, iris and choroid [ Time Frame: 36 months ]
  36. Eyelash darkening/thickening [ Time Frame: baseline ]
  37. Eyelash darkening/thickening [ Time Frame: 6 months ]
  38. Eyelash darkening/thickening [ Time Frame: 12 months ]
  39. Eyelash darkening/thickening [ Time Frame: 24 months ]
  40. Eyelash darkening/thickening [ Time Frame: 36 months ]
  41. Length of eyelash [ Time Frame: baseline ]
  42. Length of eyelash [ Time Frame: 6 months ]
  43. Length of eyelash [ Time Frame: 12 months ]
  44. Length of eyelash [ Time Frame: 24 months ]
  45. Length of eyelash [ Time Frame: 36 months ]
  46. Corneal thickness [ Time Frame: baseline ]
  47. Corneal thickness [ Time Frame: 6 months ]
  48. Corneal thickness [ Time Frame: 12 months ]
  49. Corneal thickness [ Time Frame: 24 months ]
  50. Corneal thickness [ Time Frame: 36 months ]
  51. Conjunctiva hyperemia [ Time Frame: baseline ]
  52. Conjunctiva hyperemia [ Time Frame: 6 months ]
  53. Conjunctiva hyperemia [ Time Frame: 12 months ]
  54. Conjunctiva hyperemia [ Time Frame: 24 months ]
  55. Conjunctiva hyperemia [ Time Frame: 36 months ]

Eligibility Criteria
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Pediatric populations diagnosed with glaucoma or elevated intraocular pressure
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).
Contacts and Locations
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01265719


  Show 29 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
More Information
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:
To obtain contact information for a study center near you, click here.  This link exits the ClinicalTrials.gov site

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01265719     History of Changes
Other Study ID Numbers: A6111143
LYNX ( Other Identifier: Alias Study Number )
First Posted: December 23, 2010    Key Record Dates
Last Update Posted: May 13, 2016
Last Verified: May 2016

Keywords provided by Pfizer:
Prospective
non-interventional
longitudinal
cohort study

Additional relevant MeSH terms:
Ocular Hypertension
Eye Diseases
Latanoprost
Antihypertensive Agents