Ocular Hypertension, Glaucoma
Conditions
Keywords
glaucoma, ocular hypertension, Fixed combination latanoprost-timolol, latanoprost, timolol
Brief summary
Safety and efficacy study comparing between fixed combination latanoprost-timolol and its component parts.
Interventions
placebo in the morning and latanoprost .005% in the evening
DRUGfixed combination latanoprost-timolol
one drop in the morning and placebo in the evening
DRUGtimolol 0.5%
one drop in the morning and 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 (Ltwo 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. * Patients with conditions in which treatment with B-blocking agents are contraindicated: cardiac failure, sinus bradycardia, second and third degree atrio-ventricular block. * Patients with conditions in which treatment with B-blocking agents are contraindicated: bronchial asthma, history of bronchial asthma or chronic obstructive pulmonary disease. * 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 |
|---|---|
| The differences from baseline in diurnal IOP reduction after six months of treatment will be tested between the fixed combination and the monotherapy groups. | 6 months |
| Primary objective: 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 compared the number of treatment failures and patients withdrawn due to uncontrolled IOP from baseline to Week 26 between treatment groups | 6 months |
| To describe the IOP development from baseline to Week 26 for all treatment groups | 6 months |
| To examine, within treatment groups, the diurnal IOP reducing effect from baseline for all effect from baseline between the monotherapies latanoprost and timolol | 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 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 compare the diurnal IOP reducing effect from baseline between the monotherapies latanoprost and timolol at Week 26 | 6 months |
Countries
United States
Outcome results
None listed