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Long-Term Non-Interventional Latanoprost Study (LYNX)
This study has been completed.
Sponsor:
Pfizer
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01265719
First received: December 16, 2010
Last updated: May 11, 2016
Last verified: May 2016
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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
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 ]
- Best Corrected Visual Acuity (Snellen or equivalent) [ Time Frame: 6 months ]
- Best Corrected Visual Acuity (Snellen or equivalent) [ Time Frame: 12 months ]
- Best Corrected Visual Acuity (Snellen or equivalent) [ Time Frame: 24 months ]
- Best Corrected Visual Acuity (Snellen or equivalent) [ Time Frame: 36 months ]
Secondary Outcome Measures:
- Refractive error [ Time Frame: baseline ]
- Refractive error [ Time Frame: 6 months ]
- Refractive error [ Time Frame: 12 months ]
- Refractive error [ Time Frame: 24 months ]
- Refractive error [ Time Frame: 36 months ]
- Horizontal corneal diameter [ Time Frame: baseline ]
- Horizontal corneal diameter [ Time Frame: 6 months ]
- Horizontal corneal diameter [ Time Frame: 12 months ]
- Horizontal corneal diameter [ Time Frame: 24 months ]
- Horizontal corneal diameter [ Time Frame: 36 months ]
- Intraocular pressure [ Time Frame: baseline ]
- Intraocular pressure [ Time Frame: 6 months ]
- Intraocular pressure [ Time Frame: 12 months ]
- Intraocular pressure [ Time Frame: 24 months ]
- Intraocular pressure [ Time Frame: 36 months ]
- Optic nerve changes/structures [ Time Frame: baseline ]
- Optic nerve changes/structures [ Time Frame: 6 months ]
- Optic nerve changes/structures [ Time Frame: 12 months ]
- Optic nerve changes/structures [ Time Frame: 24 months ]
- Optic nerve changes/structures [ Time Frame: 36 months ]
- Visual field [ Time Frame: baseline ]
- Visual field [ Time Frame: 6 months ]
- Visual field [ Time Frame: 12 months ]
- Visual field [ Time Frame: 24 months ]
- Visual field [ Time Frame: 36 months ]
- Iris color darkening [ Time Frame: baseline ]
- Iris color darkening [ Time Frame: 6 months ]
- Iris color darkening [ Time Frame: 12 months ]
- Iris color darkening [ Time Frame: 24 months ]
- Iris color darkening [ Time Frame: 36 months ]
- Localized pigmentation (nevi or freckles) of conjunctiva, iris and choroid [ Time Frame: baseline ]
- Localized pigmentation (nevi or freckles) of conjunctiva, iris and choroid [ Time Frame: 6 months ]
- Localized pigmentation (nevi or freckles) of conjunctiva, iris and choroid [ Time Frame: 12 months ]
- Localized pigmentation (nevi or freckles) of conjunctiva, iris and choroid [ Time Frame: 24 months ]
- Localized pigmentation (nevi or freckles) of conjunctiva, iris and choroid [ Time Frame: 36 months ]
- Eyelash darkening/thickening [ Time Frame: baseline ]
- Eyelash darkening/thickening [ Time Frame: 6 months ]
- Eyelash darkening/thickening [ Time Frame: 12 months ]
- Eyelash darkening/thickening [ Time Frame: 24 months ]
- Eyelash darkening/thickening [ Time Frame: 36 months ]
- Length of eyelash [ Time Frame: baseline ]
- Length of eyelash [ Time Frame: 6 months ]
- Length of eyelash [ Time Frame: 12 months ]
- Length of eyelash [ Time Frame: 24 months ]
- Length of eyelash [ Time Frame: 36 months ]
- Corneal thickness [ Time Frame: baseline ]
- Corneal thickness [ Time Frame: 6 months ]
- Corneal thickness [ Time Frame: 12 months ]
- Corneal thickness [ Time Frame: 24 months ]
- Corneal thickness [ Time Frame: 36 months ]
- Conjunctiva hyperemia [ Time Frame: baseline ]
- Conjunctiva hyperemia [ Time Frame: 6 months ]
- Conjunctiva hyperemia [ Time Frame: 12 months ]
- Conjunctiva hyperemia [ Time Frame: 24 months ]
- Conjunctiva hyperemia [ Time Frame: 36 months ]
| 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) |
| 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
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
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:
| Responsible Party: | Pfizer |
| ClinicalTrials.gov Identifier: | NCT01265719 History of Changes |
| Other Study ID Numbers: |
A6111143 LYNX ( Other Identifier: Alias Study Number ) |
| Study First Received: | December 16, 2010 |
| Last Updated: | May 11, 2016 |
Keywords provided by Pfizer:
|
Prospective non-interventional longitudinal cohort study |
Additional relevant MeSH terms:
|
Ocular Hypertension Eye Diseases Latanoprost Antihypertensive Agents |
ClinicalTrials.gov processed this record on September 21, 2017