Long-Term Non-Interventional Latanoprost Study - Full Text View

Purpose

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	Intervention
Glaucoma Ocular Hypertension	Other: No intervention other than routine medical care


Study Type:	Observational
Study Design:	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

Resource links provided by NLM:

Genetics Home Reference related topics: early-onset glaucoma

MedlinePlus related topics: Glaucoma

Drug Information available for: Latanoprost

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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 ]


Enrollment:	178
Study Start Date:	December 2010
Study Completion Date:	March 2016
Primary Completion Date:	March 2016 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
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

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.

Eligibility


Ages Eligible for Study:	up to 17 Years (Child)
Genders Eligible for Study:	Both
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01265719

Show 29 Study Locations

Sponsors and Collaborators

Pfizer

Investigators


Study Director:	Pfizer CT.gov Call Center	Pfizer

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
Study First Received:	December 16, 2010
Last Updated:	May 11, 2016
Health Authority:	European Union: European Medicines Agency

Keywords provided by Pfizer:


Prospective non-interventional longitudinal cohort study

Additional relevant MeSH terms:


Glaucoma Ocular Hypertension Eye Diseases Latanoprost Antihypertensive Agents

ClinicalTrials.gov processed this record on September 29, 2016

Long-Term Non-Interventional Latanoprost Study (LYNX)