Hypertension, Glaucoma, Open-Angle Clinical Trial
Official title:
An Adaptive, Multi-center, Randomized, Investigator-masked, Subject-masked, Multiple-dose, Placebo-controlled, Parallel Study to Investigate Efficacy, Safety, Tolerability and Pharmacokinetics of RO5093151 for up to 28 Days in Subjects With Primary Open Angle Glaucoma or Ocular Hypertension.
| Verified date | November 2016 |
| Source | Hoffmann-La Roche |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
This randomized, double-blind, placebo-controlled, multi-center study will evaluate the safety and the effect of RO5093151 on intraocular pressure in patients with ocular hypertension or open angle glaucoma. Patients will be randomized to receive oral doses of RO5093151 or placebo twice daily. The anticipated time on study treatment is 7 days with the possibility to extend to 28 days.
| Status | Completed |
| Enrollment | 31 |
| Est. completion date | November 2012 |
| Est. primary completion date | November 2012 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 21 Years and older |
| Eligibility |
Inclusion Criteria: - Adult patients, at least 21 years of age, inclusive - Diagnosis of ocular hypertension or primary open angle glaucoma in at least one eye - Able to participate and willing to give informed consent Exclusion Criteria: - Presence of extreme narrow angle with complete or partial closure - Progressive retinal or optic nerve disease from any cause other than glaucoma - History or signs of penetrating ocular trauma - Uncontrolled hypertension - Clinically significant abnormalities in laboratory test results - Positive test results on hepatitis B, hepatitis C, or HIV 1 and 2 - Kidney disease or dysfunction |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Hoffmann-La Roche |
United States, Bulgaria, Czech Republic, Hungary,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Change in mean intraocular pressure (IOP) at 1 hour post-dose following 7 days of treatment | Day 7 | No | |
| Secondary | Change in mean daily intraocular pressure (IOP) | Up to 28 days | No | |
| Secondary | Change in mean intraocular pressure (IOP) at each assessment time-points | Up to 28 days | No | |
| Secondary | Change in intraocular pressure (IOP) during a placebo lead-in phase | 7 days | No | |
| Secondary | Pharmacokinetics (area under the concentration time curve) | Day 7 | No | |
| Secondary | Urinary ratio of tetrahydrocortisol to tetrahydrocortisone | 7 days | No | |
| Secondary | Safety (incidence of adverse events) | Up to 28 days | No |