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

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
|
- 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 ]
- 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 ]

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, Learn About Clinical Studies.
Ages Eligible for Study: | up to 17 Years (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
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).

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

Study Director: | Pfizer CT.gov Call Center | Pfizer |
Additional Information:
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 |