None listed
Conditions
Interventions
Group 1 Type of group
Timolol 0.5% dosed twice-daily
Group name:Group 2 Type of group
Latanoprost 0.005% ophthalmic solution dosed once-daily
Sponsors
PFIZER S.A.,
Eligibility
Age
No minimum to 18 Years
Inclusion criteria
Inclusion criteria: • are children or adolescents of both sexes 22 mm Hg in one of the eyes; • receive topical treatment or have never received pharmacological treatment; • have signed and dated an informed consent document indicating that the patient´s parent (or legal guardian) has been informed of all relevant aspects of the study. If required by local law, it will be necessary to obtain a signed and dated confirmation. • wish to attend scheduled visits and can do so (the parent or legal guardian).
Exclusion criteria
Exclusion criteria: • require surgical intervention to repair the angle or to open or widen the angle of the anterior chamber; • have not responded to a long-term therapeutic intervention with timolol or a prostaglandin to control the elevation of IOP; • have undergone cyclodestructor procedures; • cannot expect reasonable improvement with pharmacological treatment, which will be administered in addition to previous filtering surgical interventions (eg, trabeculectoinia) or drainage implants (a history of surgery or implants does not imply an exclusion requirement); • suffer from or have suffered from other disorders in which beta-blocker therapy is contraindicated, such as heart failure, cardiogenic shock, sinus bradycardia, second and third degree atrioventricular block, bronchial asthma or history in this regard, and obstructive pulmonary disease; • have inflammation / eye infection or a history of it in the 3 months prior to the baseline visit; • have a history of trauma or eye ciragia in any eye in the month prior to the baseline visit • have a history of allergy to any of the components of the study medication (eg, hypersensitivity to benzalkonium chloride or to any other component of Xalatan or timolol); • suffer from any commensal disorder that prevents measuring pressure; • have or have had chronic allergic conjunctivitis, chronic keratitis or lacrimal deficit; • received systemic and / or ocular asteroids in the month following the baseline visit (eg, prednisolone drops); • foresee that, during the study period, they will need to start receiving medication (systemic or topical) that affects the IOP or modify it; • present or have presented any other serious, acute or chronic medical or psychiatric disorder that may increase the risk associated with participating in the trial or interfere with the interpretation of the study results and, in the opinion of the researcher, prevent the participation of the Subject in this essay. • have used an experimental drug or device within 30 days prior to the baseline visit; • be pregnant or nursing women; [girls of childbearing age (10 years of age and older, or who are menstruating) must obtain a negative result on a pregnancy test, and those who do not want or cannot follow the instructions to avoid pregnancy, from at least 14 days before the administration of the first dose of the study medication until the end of the follow-up procedure, they will not be able to participate in the trial], (when entering the study the appropriate contraceptive methods will be indicated).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Calculated as Baseline IOP minus Week 12 IOP, LOCF. IOP measured using 1 of 3 methods: Goldmann applanation tonometry (preferred method, if feasible), Perkins tonometry, or TonoPen. IOP was measured twice and if the measurements were less than or equal to (≤) 2 millimeters of mercury (mmHg) of each other, the mean of the 2 readings was recorded as the IOP at that time point. Otherwise, a third IOP measurement was taken and the median IOP recorded. Measure:Reduction From Baseline in Mean IOP at Week 12, Last Observation Carried Forward (LOCF) Timepoints:Baseline, Week 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Calculated as Baseline IOP minus Week 1 IOP (observed). IOP measured using 1 of 3 methods: Goldmann applanation tonometry (preferred method, if feasible), Perkins tonometry, or TonoPen. IOP was measured twice and if the measurements were ≤ 2 mmHg of each other, the mean of the 2 readings was recorded as the IOP at that time point. Otherwise, a third IOP measurement was taken and the median IOP recorded. Measure:Reduction From Baseline in Mean IOP at Week 1 Timepoints:Baseline, Week 1 ; Outcome name:Calculated as Baseline IOP minus Week 4 IOP (observed). IOP measured using 1 of 3 methods: Goldmann applanation tonometry (preferred method, if feasible), Perkins tonometry, or TonoPen. IOP was measured twice and if the measurements were ≤ 2 mmHg of each other, the mean of the 2 readings was recorded as the IOP at that time point. Otherwise, a third IOP measurement was taken and the median IOP recorded. Measure:Reduction From Baseline in Mean IOP at Week 4 Timepoints:Baseline, Week 4 ; Outcome name:Calculated as Baseline IOP minus Week 12 IOP (observed). IOP measured using 1 of 3 methods: Goldmann applanation tonometry (preferred method, if feasible), Perkins tonometry, or TonoPen. IOP was measured twice and if the measurements were ≤ 2 mmHg of each other, the mean of the 2 readings was recorded as the IOP at that time point. Otherwise, a third IOP measurement was taken and the median IOP recorded. Measure:Reduction From Baseline in Mean IOP at Week 12 (Observed) Timepoints:Baseline, Week 12 ; Outcome name:IOP measured using 1 of 3 methods: Goldmann applanation tonometry (preferred method, if feasible), Perkins tonometry, or TonoPen. IOP was measured twice and if the measurements were ≤ 2 mmHg of each other, the mean of the 2 readings was recorded as the IOP at that time point. Otherwise, a third IOP measurement was taken and the median IOP recorded. Measure:Mean IOP at Baseline | — |
Countries
Belgium, Czech Republic, Denmark, France, Germany, Greece, Italy, Peru, Portugal, Slovakia, Spain, United Kindgdom
Contacts
Public ContactLuciana Obreros
PFIZER S.A.
Outcome results
None listed