Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of the study is to assess the safety, tolerability, and IOP effects of RO5093151 following 7 days of topical ocular treatment in patients with primary open angle glaucoma or ocular hypertension.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A | Experimental | Participants will receive up to 3 multiple ascending dose levels with the starting dose of 0.1% RO5093151 (topical ocular instillation) and sequentially 0.5% and 1% RO5093151 doses or placebo (3:1, active:placebo) twice a day (BID) on Day 1 and once a day (QD) for 6 days. |
|
| Part B | Experimental | Participants will receive highest feasible dose (HFD) or maximum tolerated dose (MTD) of RO5093151 from Part A or 0.005% latanoprost (topical ocular instillation) once daily for 7 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Latanoprost | Drug | Latanoprost is a ophthalmic solution, available in dose strength as 0.005%. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse events | Up to 12 weeks | |
| Changes in vital signs, electrocardiogram (ECG), opthalmologic assessments, and clinical laboratory results | Up to 12 weeks | |
| Change in mean IOP after 7 days treatment vs baseline: change from baseline for RO5093151 and latanoprost and difference in change from baseline between RO5093151 and latanoprost | Baseline (Day 1) and Day 8 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in IOP at matched clock-times after 7 days of treatment vs baseline (diurnal IOP) and between RO5093151 and latanoprost | Baseline and Day 8 | |
| Maximum observed plasma concentration (Cmax) | Day 1: Pre-dose (morning); 30 minutes, 1, 4, 8, 11 (evening pre-dose) and 12 hours post-dose; Day 7: Pre-dose (evening), 1, 12 (Day 8), 16 (Day 8), 20 (Day 8) hours post-dose |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sall Research Medical Center | Artesia | California | 90701 | United States | ||
| Rocky Mountain Lions Eye Inst |
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo |
| Drug |
Matching placebo formulation will be administered in Part A. |
|
| RO5093151 | Drug | RO5093151 is a ophthalmic solution, available in dose strengths as 0.1%, 0.5% and 1%. |
|
| Time to maximum observed plasma concentration (Tmax) | Day 1: Pre-dose (morning); 30 minutes, 1, 4, 8, 11 (evening pre-dose) and 12 hours post-dose; Day 7: Pre-dose (evening), 1, 12 (Day 8), 16 (Day 8), 20 (Day 8) hours post-dose |
| Concentration at the end of a dosing interval before the next dose administration (Ctrough) | Day 1: Pre-dose (morning); 30 minutes, 1, 4, 8, 11 (evening pre-dose) and 12 hours post-dose; Day 7: Pre-dose (evening), 1, 12 (Day 8), 16 (Day 8), 20 (Day 8) hours post-dose |
| Area under the plasma concentration versus time curve from zero to 24 h post-dose (AUC0-24) | Day 1: Pre-dose (morning); 30 minutes, 1, 4, 8, 11 (evening pre-dose) and 12 hours post-dose; Day 7: Pre-dose (evening), 1, 12 (Day 8), 16 (Day 8), 20 (Day 8) hours post-dose |
| Area under the plasma concentration versus time curve up to the last measurable concentration (AUClast) | Day 1: Pre-dose (morning); 30 minutes, 1, 4, 8, 11 (evening pre-dose) and 12 hours post-dose; Day 7: Pre-dose (evening), 1, 12 (Day 8), 16 (Day 8), 20 (Day 8) hours post-dose |
| Apparent terminal half-life (T1/2) | Day 1: Pre-dose (morning); 30 minutes, 1, 4, 8, 11 (evening pre-dose) and 12 hours post-dose; Day 7: Pre-dose (evening), 1, 12 (Day 8), 16 (Day 8), 20 (Day 8) hours post-dose |
| Aurora |
| Colorado |
| 80045 |
| United States |
| Eye Care Centers Management, Inc. (Clayton Eye Center) | Morrow | Georgia | 30260 | United States |
| New York Eye and Ear Infirmary of Mt. Sinai; New York Glaucoma Research Institute | New York | New York | 10003 | United States |
| Cornerstone Eye Care, Div of Cornerstone Health Care | High Point | North Carolina | 27262 | United States |
| West Virginia University Eye Institute | Morgantown | West Virginia | 26506 | United States |
| Singapore National Eye Centre; Glaucoma Department | Singapore | 168751 | Singapore |
| ID | Term |
|---|---|
| D005901 | Glaucoma |
| ID | Term |
|---|---|
| D009798 | Ocular Hypertension |
| D005128 | Eye Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077338 | Latanoprost |
| ID | Term |
|---|---|
| D011461 | Prostaglandins F, Synthetic |
| D011465 | Prostaglandins, Synthetic |
| D011453 | Prostaglandins |
| D015777 | Eicosanoids |
| D005231 | Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D012898 | Autacoids |
| D018836 | Inflammation Mediators |
| D001685 | Biological Factors |
Not provided
Not provided