Ocular Hypertension, Glaucoma, Open-angle Glaucoma
Conditions
Keywords
open-angle glaucoma ocular hypertension glaucoma
Brief summary
The purpose of this study is to demonstrate that fixed combination of latanoprost and timolol (PhXA41) has better IOP lowering effect than the individual monotherapies.
Interventions
DRUGi. Fixed combination of latanoprost 0.005% and timolol 0.5%
one drop in the morning and placebo in the evening
one drop in the morning and evening
placebo in the morning and latanoprost .005% in the evening
Sponsors
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Unilateral or bilateral primary open angle glaucoma, capsular glaucoma, pigmentary glaucoma or ocular hypertension. * Patients currently on IOP reducing therapy: IOP greater than or equal to 25mmHg (two IOP determinations at pre-study separated by at least one hour) OR Patients without IOP reducing therapy: IOP greater than or equal to 30mmHg (two IOP determinations at pre-study separated by at least one hour).
Exclusion criteria
* History of acute angle closure or closed/barely open anterior chamber angle. * Current use of contact lenses. * Ocular surgery or argon laser trabeculoplasty (ALT) within three months prior to pre-study visit. * Ocular inflammation/infection occurring within three months prior to pre-study visit. * Hypersensitivity to benzalkonium chloride or to any other component of the study drug solutions. * Other abnormal ocular condition or symptom preventing the patient from entering the study, according to the investigator's judgement. * Cardiac failure, sinus bradycardia, second and third degree of atrioventricular block. (The routines for prescribing topical B-blocking agents will be followed. * Bronchial asthma, history of bronchial asthma or chronic obstructive pulmonary disease. (The routines for prescribing topical B-blocking agents will be followed). * Pregnancy * Women of childbearing potential who has not used adequate contraceptive methods during the last three months. * Inability to adhere to treatment/visit plan. * Have participated in any other clinical study within one month prior to pre-study visit.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To demonstrate that the fixed combination of latanoprost and timolol has a better IOP-reducing effect than the individual monotherapies. | 6 months |
Secondary
| Measure | Time frame |
|---|---|
| To compare the diurnal IOP reducing effect from baseline between the monotherapies latanoprost and timolol at Week 26 | 6 Months |
| To compare the number of treatment failures and patients withdrawn due to uncontrolled IOP from baseline to Week 26 between treatment groups | 6 Months |
| To compare the proportion of patients reaching pre-specified (15, 18, and 21 mmHg) target diurnal IOPs between the treatment groups at Week 26 | 6 Months |
| To examine, within treatment groups, the diurnal IOP reducing effect from baseline for all treatments at Week 26 | 6 Months |
| To compared the IOP reducing effect from baseline to Week 26 of the monotherapies with the IOP reducing effect from Week 26 to Week 52 of the fixed combination | 6 Months |
| To examine, within the fixed combination treatment group, the diurnal IOP reducing effect from baseline to Week 26 and Week 52 | 6 Months |
| To follow the safety variables throughout the study periods. | 6 Months |
| To describe the IOP development from baseline to Week 26 for all treatment groups | 6 Months |
Countries
Germany
Outcome results
None listed