Glaucoma, Ocular Hypertension
Conditions
Brief summary
This study is designed as an open label evaluation of the efficacy of latanoprost and timolol fixed combination (Xalacom) after 6 month of treatment. Eligible patients may be enrolled at the baseline visit. All current ocular hypotensive therapy must be discontinued at this time. On baseline day, patients eligible for the study will receive Xalacom which is to be instilled in the morning.
Interventions
DRUGXalacom
Sponsors
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosis of glaucoma (primary open angle, pigmentary, exfoliative) or ocular hypertension (IOP \>= 21 mmHG). * Visual acuity \>= 20/200.
Exclusion criteria
* Closed/barely open anterior chamber angle or history of acute angle closure glaucoma. * Hystory of ALT within 3 months prior to the baseline visit. * History of any ocular filtering surgical intervention. * Ocular surgery or inflammation/infection within 3 months prior to the baseline visit.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| IOP change from baseline to the 6-month visit. | — |
Secondary
| Measure | Time frame |
|---|---|
| % reduction of IOP change from baseline to the 6-month visit. | — |
| Proportion of pts achieving different levels of mean % of IOP reduction at the end of the treatment(eg:0%,10%,15%,20%,etc). | — |
| Proportion of pts who reach specific IOP levels at the end of treatment(eg:16,17,18,19 mmHg,etc). | — |
Countries
Italy
Outcome results
None listed