Ocular Hypertension, Primary Open Angle Glaucoma
Conditions
Brief summary
The primary objective of this study was to compare the change in intraocular pressure (IOP) of three different doses of latanoprost (75, 100 and 125 ug/ml) to that of the marketed 50 ug/ml dose, in a dose ranging study.
Interventions
DRUGlatanoprost 75 ug
Eligible patients were randomized to receive 1 of 4 different doses of latanoprost (50, 75, 100 or 125 ug/mL). Study medication was supplied in clear bottles. Patients were instructed to instill one drop of study medication in one or both eyes (as instructed by their investigator) once daily in the evening between 7 PM and 9 PM during the entire treatment period. The first dose of study medication was instilled in the evening of the baseline visit and the last dose was instilled in the evening before the Week 4 (Day 28) visit.
DRUGlatanoprost 100 ug
Eligible patients were randomized to receive 1 of 4 different doses of latanoprost (50, 75, 100 or 125 ug/mL). Study medication was supplied in clear bottles. Patients were instructed to instill one drop of study medication in one or both eyes (as instructed by their investigator) once daily in the evening between 7 PM and 9 PM during the entire treatment period. The first dose of study medication was instilled in the evening of the baseline visit and the last dose was instilled in the evening before the Week 4 (Day 28) visit.
DRUGlatanoprost 125 ug
Eligible patients were randomized to receive 1 of 4 different doses of latanoprost (50, 75, 100 or 125 ug/mL). Study medication was supplied in clear bottles. Patients were instructed to instill one drop of study medication in one or both eyes (as instructed by their investigator) once daily in the evening between 7 PM and 9 PM during the entire treatment period. The first dose of study medication was instilled in the evening of the baseline visit and the last dose was instilled in the evening before the Week 4 (Day 28) visit.
DRUGlatanoprost 50 ug
Eligible patients were randomized to receive 1 of 4 different doses of latanoprost (50, 75, 100 or 125 ug/mL). Study medication was supplied in clear bottles. Patients were instructed to instill one drop of study medication in one or both eyes (as instructed by their investigator) once daily in the evening between 7 PM and 9 PM during the entire treatment period. The first dose of study medication was instilled in the evening of the baseline visit and the last dose was instilled in the evening before the Week 4 (Day 28) visit.
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
* Male or female, 18 years of age or older. * Primary open angle glaucoma (POAG) or ocular hypertension (OHT) requiring unilateral or bilateral administration of intraocular pressure (IOP) lowering treatment, including patients who were naïve to IOP lowering treatment. * IOP between ≥ 24 mmHg and ≤ 36 mmHg in at least one eye at the 8 AM time point at baseline/randomization.
Exclusion criteria
* Closed/barely open anterior chamber angle or a history of acute angle closure. * A history of discontinued prostaglandin IOP lowering treatment, unless the reason for discontinuation was participation in a clinical study. * Ocular surgery or argon laser trabeculoplasty in one or both eyes within 3 months prior to the screening visit. * Use or anticipated requirement during the study of any topical medication that was known to affect IOP. * Anticipated need to modify systemic medication known to affect IOP (eg, beta-adrenergic antagonists, alpha-adrenergic agonists, calcium channel blockers, angiotension converting enzyme inhibitors, and angiotension II receptor antagonists) during the study period.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint was the change in intraocular pressure (IOP) at 8 AM and 4 PM from baseline to Week 4 (Day 28). | Baseline and Day 28 |
Secondary
| Measure | Time frame |
|---|---|
| The change in intraocular pressure (IOP) at 8 AM and 4 PM from baseline across all clinic visits; comparisons were made by separate analyses for each time point and visit. | Baseline and Day 28 |
| The percentage change in IOP from baseline at 8 AM to Week 4 (Day 28). | Baseline and Day 28 |
| Ocular safety assessments (ie, ocular adverse events, assessment of conjunctival hyperemia, and ocular symptom evaluations) across all clinic visits. | Baseline and Day 28 |
Countries
Australia, Czechia, France, Greece, Pakistan, Portugal, Thailand, United Kingdom
Outcome results
None listed