Ocular Hypertension, Open-Angle Glaucoma
Conditions
Keywords
Open-Angle Glaucoma (OAG), Ocular Hypertension (OHT), Bimatoprost
Brief summary
This study evaluates the duration of intraocular pressure (IOP)-lowering effect and safety of as needed administrations of Bimatoprost sustained release (SR) in participants with open-angle glaucoma (OAG) or ocular hypertension (OHT) who are not adequately managed with topical IOP-lowering medication for reasons other than medication efficacy.
Interventions
DRUGBimatoprost (SR)
Study Eye: Cycles 1 - 3 administrations through the PRN treatment period. Fellow Eye: Standard of care or Bimatoprost SR.
Sponsors
AbbVie
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
\- Diagnosis of either open angle glaucoma (OAG) (i.e., primary OAG, pseudoexfoliation glaucoma, pigmentary glaucoma) or ocular hypertension requiring intraocular pressure-lowering treatment.
Exclusion criteria
* Concurrent or anticipated enrollment in another investigational drug or device study or participation in such a study within 2 months prior to enrolling in this study. * Previous administration with Bimatoprost SR in the study eye.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Retreatment or rescue administered for IOP | Up to 48 months | Treatment modality determined by investigator. |
| Number of patients experiencing a treatment emergent adverse event | Baseline up to 48 months | The number of patients who experienced one or more TEAE during the 48 month treatment period. |
Countries
Argentina, Australia, Bulgaria, Czechia, Denmark, Germany, Hungary, Ireland, Italy, New Zealand, Poland, Russia, South Africa, Sweden, United Kingdom, United States
Outcome results
None listed