Long-Term Non-Interventional Latanoprost Study (LYNX)

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01265719
First received: December 16, 2010
Last updated: October 15, 2014
Last verified: October 2014

December 16, 2010
October 15, 2014
December 2010
March 2016   (final data collection date for primary outcome measure)
  • Best Corrected Visual Acuity (Snellen or equivalent) [ Time Frame: baseline ] [ Designated as safety issue: No ]
  • Best Corrected Visual Acuity (Snellen or equivalent) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Best Corrected Visual Acuity (Snellen or equivalent) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Best Corrected Visual Acuity (Snellen or equivalent) [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Best Corrected Visual Acuity (Snellen or equivalent) [ Time Frame: 36 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01265719 on ClinicalTrials.gov Archive Site
  • Refractive error [ Time Frame: baseline ] [ Designated as safety issue: No ]
  • Refractive error [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Refractive error [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Refractive error [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Refractive error [ Time Frame: 36 months ] [ Designated as safety issue: No ]
  • Horizontal corneal diameter [ Time Frame: baseline ] [ Designated as safety issue: No ]
  • Horizontal corneal diameter [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Horizontal corneal diameter [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Horizontal corneal diameter [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Horizontal corneal diameter [ Time Frame: 36 months ] [ Designated as safety issue: No ]
  • Intraocular pressure [ Time Frame: baseline ] [ Designated as safety issue: No ]
  • Intraocular pressure [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Intraocular pressure [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Intraocular pressure [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Intraocular pressure [ Time Frame: 36 months ] [ Designated as safety issue: No ]
  • Optic nerve changes/structures [ Time Frame: baseline ] [ Designated as safety issue: No ]
  • Optic nerve changes/structures [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Optic nerve changes/structures [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Optic nerve changes/structures [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Optic nerve changes/structures [ Time Frame: 36 months ] [ Designated as safety issue: No ]
  • Visual field [ Time Frame: baseline ] [ Designated as safety issue: No ]
  • Visual field [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Visual field [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Visual field [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Visual field [ Time Frame: 36 months ] [ Designated as safety issue: No ]
  • Iris color darkening [ Time Frame: baseline ] [ Designated as safety issue: Yes ]
  • Iris color darkening [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • Iris color darkening [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • Iris color darkening [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
  • Iris color darkening [ Time Frame: 36 months ] [ Designated as safety issue: Yes ]
  • Localized pigmentation (nevi or freckles) of conjunctiva, iris and choroid [ Time Frame: baseline ] [ Designated as safety issue: No ]
  • Localized pigmentation (nevi or freckles) of conjunctiva, iris and choroid [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Localized pigmentation (nevi or freckles) of conjunctiva, iris and choroid [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Localized pigmentation (nevi or freckles) of conjunctiva, iris and choroid [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Localized pigmentation (nevi or freckles) of conjunctiva, iris and choroid [ Time Frame: 36 months ] [ Designated as safety issue: No ]
  • Eyelash darkening/thickening [ Time Frame: baseline ] [ Designated as safety issue: Yes ]
  • Eyelash darkening/thickening [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • Eyelash darkening/thickening [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • Eyelash darkening/thickening [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
  • Eyelash darkening/thickening [ Time Frame: 36 months ] [ Designated as safety issue: Yes ]
  • Length of eyelash [ Time Frame: baseline ] [ Designated as safety issue: Yes ]
  • Length of eyelash [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • Length of eyelash [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • Length of eyelash [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
  • Length of eyelash [ Time Frame: 36 months ] [ Designated as safety issue: Yes ]
  • Corneal thickness [ Time Frame: baseline ] [ Designated as safety issue: No ]
  • Corneal thickness [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Corneal thickness [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Corneal thickness [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Corneal thickness [ Time Frame: 36 months ] [ Designated as safety issue: No ]
  • Conjunctiva hyperemia [ Time Frame: baseline ] [ Designated as safety issue: Yes ]
  • Conjunctiva hyperemia [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • Conjunctiva hyperemia [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • Conjunctiva hyperemia [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
  • Conjunctiva hyperemia [ Time Frame: 36 months ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
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.
 
Enrolling by invitation
150
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).
Both
up to 18 Years
No
Contact information is only displayed when the study is recruiting subjects
Portugal,   Sweden,   Italy,   United Kingdom,   France,   Colombia,   Slovakia,   Czech Republic,   Denmark,   Spain,   Germany,   Belgium,   Greece,   Peru
 
NCT01265719
A6111143, LYNX
No
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP