Long-Term Non-Interventional Latanoprost Study (LYNX)
This study is currently recruiting participants.
Verified May 2013 by Pfizer
Sponsor:
Pfizer
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01265719
First received: December 16, 2010
Last updated: May 1, 2013
Last verified: May 2013
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Purpose
This is a non-interventional, prospective, longitudinal cohort study. A total of 200 pediatric subjects with glaucoma or elevated intraocular pressure, including 150 latanoprost-treated subjects and 50 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 | Phase |
|---|---|---|
|
Glaucoma Ocular Hypertension |
Other: No intervention other than routine medical care |
Phase 4 |
| 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 ] [ 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 ]
| Estimated Enrollment: | 200 |
| Study Start Date: | December 2010 |
| Estimated Study Completion Date: | January 2016 |
| Estimated Primary Completion Date: | January 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 years; 1-<5 years; and 5-<18 years.
Eligibility| Ages Eligible for Study: | up to 17 Years |
| 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01265719
Contacts
| Contact: Pfizer CT.gov Call Center | 1-800-718-1021 |
Locations
| Belgium | |
| Universitair Ziekenhuis Antwerpen, Dienst Oftalmologie | Recruiting |
| Edegem, Belgium, 2650 | |
| Universitair Ziekenhuis Leuven - Campus Sint-Raphaël | Recruiting |
| Leuven, Belgium, 3000 | |
| Czech Republic | |
| Fakultni nemocnice Brno | Recruiting |
| Brno, Czech Republic, 613 00 | |
| Fakultni nemocnice v Motole | Recruiting |
| Praha 5, Czech Republic, 150 06 | |
| Denmark | |
| Glostrup Hospital, Oegenafdelingen | Recruiting |
| Glostrup, Denmark, 2600 | |
| France | |
| Hopital Claude Huriez | Recruiting |
| Lille Cedex, France, 59037 | |
| Germany | |
| Universitaetsklinikum Giessen | Recruiting |
| Giessen, HE, Germany, 35392 | |
| Universitaetsklinikum Hamburg-Eppendorf | Recruiting |
| Hamburg, HH, Germany, 20246 | |
| Universitaetsklinikum Mainz | Recruiting |
| Mainz, RP, Germany, 55131 | |
| Greece | |
| University General Hospital of Thessaloniki AHEPA | Recruiting |
| Thessaloniki, Greece, 54636 | |
| Italy | |
| Azienda Ospedaliero Univ. | Recruiting |
| Catania, CT, Italy, 95123 | |
| Ospedale Pediatrico Bambino Gesu | Recruiting |
| Fiumicino (Roma), Italy, 00050 | |
| Unita' Operativa di Oculistica Pediatrica, Azienda Ospedaliera Ospedale Niguarda Ca'Grande | Recruiting |
| Milano, Italy, 20162 | |
| Portugal | |
| AIBILI - Associação para a Investigação Biomédica e Inovação em Luz e Imagem | Recruiting |
| Coimbra, Portugal, 3000-354 | |
| Slovakia | |
| Detska Fakultna nemocnica s poliklinikou Bratislava | Recruiting |
| Bratislava, Slovakia, 83340 | |
| Spain | |
| Hospital Sant Joan de Deu | Recruiting |
| Esplugues de Llobregat, Barcelona, Spain, 08950 | |
| Hospital Clinico San Carlos | Recruiting |
| Madrid, Spain, 28040 | |
| Hospital Virgen Del Rocio | Recruiting |
| Sevilla, Spain, 41013 | |
| Hospital Universitario Miguel Servet | Recruiting |
| Zaragoza, Spain, 50009 | |
| Sweden | |
| Akademiska Sjukhuset | Recruiting |
| Uppsala, Sweden, 751 85 | |
| Ogonkliniken, Centrallasarett | Recruiting |
| Vasteras, Sweden, 721 89 | |
| United Kingdom | |
| Manchester Royal Eye Hospital | Active, not recruiting |
| Manchester, Gt Man, United Kingdom, M13 9WH | |
| Birmingham and Midland Eye Centre, Consultant Ophthalmologist | Recruiting |
| Birmingham, United Kingdom, B18 7QH | |
| Richard Desmond Childrens Eye Centre | Recruiting |
| London, United Kingdom, EC1V 2PD | |
Sponsors and Collaborators
Pfizer
Investigators
| Study Director: | Pfizer CT.gov Call Center | Pfizer |
More Information
Additional Information:
No publications provided
| Responsible Party: | Pfizer |
| ClinicalTrials.gov Identifier: | NCT01265719 History of Changes |
| Other Study ID Numbers: | A6111143 |
| Study First Received: | December 16, 2010 |
| Last Updated: | May 1, 2013 |
| Health Authority: | European Union: European Medicines Agency |
Keywords provided by Pfizer:
|
Prospective non-interventional longitudinal cohort study |
Additional relevant MeSH terms:
|
Glaucoma Hypertension Ocular Hypertension Eye Diseases Vascular Diseases Cardiovascular Diseases |
Latanoprost Antihypertensive Agents Cardiovascular Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 23, 2013