Glaucoma
Conditions
Interventions
Travoprost/Timolol fixed combination ophthalmic solution for 3 months
Sponsors
I.CHANGE study group
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Age at the time of the agreement 20 years old or older. 2.Gender and outpatient or the hospitalization are no object. 3.Must have been treated monotherapy with PGAs for 3 months or longer for the study eye, by the time of baseline examinations. 4.Patients who are judged to require the switch of Duotrav with be not able to achieve target IOP as on their current IOP-lowering monotherapy
Exclusion criteria
Exclusion criteria: 1.Complications with chronic or recurrent uveitis,scleritis,or corneal herpes. 2.History of ocular trauma or intraocular conventional surgery or laser ocular surgery in the study eye within 3 months before baseline examinations. 3.Any abnormality preventing reliable applanation tonometer in the study eye. 4.Known medical history of allergic to PGAs or beta-blockers. 5.Contraindication of beta-blockers 6.Patients using an IOP-lowering drug other than those to be used in the study. 7.Patients using systemic administration of an oral CAI (Diamox,etc.) 8.Patient having serious eyes complications 9.Women who are pregnant or lactating 10.Severe dementia 11.Patients who are judged to be inappropriate for participation in the study for other reason by the doctor in charge.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy IOP value;IOP-lowering effect from baseline(reduced value;reduction rate%) | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety 1.Ocular safety assessment: Conjunctival hyperemia,adverse events 2.Systemic safety assessment: Blood pressure,the pulse,adverse events | — |
Countries
Japan
Contacts
Public ContactTadashi Nakano
The Jikei University Ophthalmology
Outcome results
None listed