MedDRA version: 9.1 Level: LLT Classification code 10010486 Term: Congenital glaucoma
Conditions
Interventions
Trade Name: Xalatan- 0.005% w/v eye drops solution
Pharmaceutical Form: Eye drops, solution
CAS Number: 130209-82-4
Other descriptive name: latanoprost 0.005% ophthalmic solution
Concentration unit:
Sponsors
Pfizer Inc. 235 East 42nd Street, NEW YORK, NY 10017. US
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Are male or female =18 years of age (neonates are required to be at least 36 weeks gestational age); 2. Have a diagnosis of paediatric glaucoma; 3. Require pharmacological intervention with IOP reducing therapy in at least 1 eye; 4. Have a morning (before mid day) baseline visit IOP =22 mmHg in at least 1 eye; 5. Are on topical therapy or are naïve to pharmacologic treatment; 6. Have signed and dated an informed consent document indicating that subject’s parent (or legal guardian) had been informed of all pertinent aspects of the study. A signed and dated assent will be required where applicable according to local laws. 7. Are willing and able to comply with scheduled visits (parent or legal guardian). Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Require surgery for acute angle closure or closed or a narrowly open anterior chamber angle; 2. Have failed previous long term therapeutic intervention with either timolol or a prostaglandin to control elevated IOP; 3. Have had prior cyclodestructive procedures; 4. Cannot expect reasonable improvement by pharmacologic treatment, which is given in addition to filtering surgeries (eg, trabeculectomy) or drainage implants (history of surgery or implant is not the condition of exclusion); 5. Have or have had other medical condition(s) in which treatment with beta blocking agents are contraindicated such as heart failure, sinus bradycardia, second and third degree atrio ventricular block, bronchial asthma or history thereof, and obstructive pulmonary disease; 6. Have ocular inflammation/infection or a history of ocular inflammation/infection within 3 months prior to the baseline visit; 7. Have a history of ocular trauma or surgery in either eye within 1 month of the baseline visit; 8. Have a history of allergy to any of the ingredients contained in the study medications (eg, hypersensitivity to benzalkonium chloride, or to any other component in Xalatan and or timolol); 9. Have any corneal condition that would prevent tonometric measurements; 10. Have, or have had a history of chronic allergic conjunctivitis, chronic keratitis or lacrimal deficiency; 11. Have taken systemic and/or ocular steroids within 1 month of the baseline visit (eg, prednisolone drops); 12. Anticipate the need to initiate or modify medication (systemic or topical) that is known to affect IOP during the study period; 13. Have, or have had a history of any other severe acute or chronic medical or psychiatric condition that could increase the risk associated with study participation or could interfere with the interpretation of study results and, in the judgment of the investigator, could make the subject inappropriate for entry into this study; 14. Have used an investigational drug or device within 30 days of the baseline visit; 15. Is pregnant or nursing females; [menarchal females of child bearing potential (females age 10 or greater, or who are menarchal) must have a negative pregnancy test, and those who are unwilling or unable to follow the instruction to avoid pregnancy, from at least 14 days prior to the first dose of trial mediation until completion of follow up procedure, will not participate to the trial.] (proper methods to avoid pregnancy should be instructed at the entrance of the study).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the relative effectiveness of latanoprost 0.005% ophthalmic solution dosed once daily and timolol 0.5% dosed twice daily in paediatric subjects =18 years of age who are diagnosed with paediatric glaucoma. Specifically, to demonstrate that latanoprost is not inferior to timolol within a non inferiority margin of 3 mm Hg, with an option of switching to superiority, in the event that the lower limit of the 95% confidence interval for the treatment difference not only lies above the non inferiority margin but also above zero.;Secondary Objective: To evaluate the safety of latanoprost 0.005% ophthalmic solution dosed once daily and timolol 0.5% dosed twice daily in paediatric subjects =18 years of age who are diagnosed with paediatric glaucoma. To compare latanoprost 0.005% ophthalmic solution dosed once daily and timolol 0.5% dosed twice daily in paediatric subjects =18 years of age who are diagnosed with paediatric glaucoma, with respect to the proportion of patients with at least a 15% lowering of baseline IOP (responder analysis). ;Primary end point(s): Mean change from baseline IOP in the study eye at Week 12 | — |
Countries
Belgium, Czech Republic, Denmark, France, Germany, Greece, Italy, Portugal, Slovakia, Spain, United Kingdom
Outcome results
None listed