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NCT01670266 · ClinicalTrials.gov registry record · Phase 1
Single and Multiple Dose Escalation and Two-sequence Crossover Study of ONO-9054 in Patients With Ocular Hypertension or Mild Open-angle Glaucoma
A Phase 1 study, sponsored by Ono Pharma USA.
- Completed
- Registry status
- Phase 1
- Development phase
- 60
- Enrollment target
NCT01670266: Completed Phase 1 study, sponsored by Ono Pharma USA.
NCT01670266 is a Phase 1 study that has completed, run by Ono Pharma USA. The registered enrollment target is 60 participants, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01670266, a Phase 1 study, has completed, sponsored by Ono Pharma USA.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 60 participants
- Enrollment target
Study Summary
The primary objective of this study is to evaluate the safety and tolerability of 3 planned doses of ONO-9054 in the eyes of adult male and female patients with ocular hypertension (OHT) or mild open angle-glaucoma (OAG). The secondary objectives are to evaluate Pharmacodynamics (PD) and to characterize the pharmacokinetic (PK) profile of ONO-9054 and its metabolite in plasma and to compare its tolerability following morning and evening dosing.
Primary Outcome
Safety and tolerability of ONO-9054 will be measured using vital signs, ECGs, laboratory tests, ocular exams, physical examination and incidence/severity of adverse events over a dosing period of up to 14 days
Interventions
- DRUG Placebo
- DRUG ONO-9054
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2012-08 |
| Phase | Phase 1 |
What the finished NCT01670266 record still lists
NCT01670266 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01670266 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01670266 about?
NCT01670266 is a clinical study titled "Single and Multiple Dose Escalation and Two-sequence Crossover Study of ONO-9054 in Patients With Ocular Hypertension or Mild Open-angle Glaucoma". The primary objective of this study is to evaluate the safety and tolerability of 3 planned doses of ONO-9054 in the eyes of adult male and female patients with ocular hypertension (OHT) or mild open angle-glaucoma (OAG). The secondary objectives are to evaluate Pharmacodynamics (PD) and to charact...
What is the current status of trial NCT01670266?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 60 participants. The study started on 2012-08.
What interventions are being tested in trial NCT01670266?
The interventions under investigation include: Placebo (DRUG), ONO-9054 (DRUG).
Who is sponsoring clinical trial NCT01670266?
This trial is sponsored by Ono Pharma USA, which has 17 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01670266's enrollment target sits among peer trials
60 831st of 2000 higher than 1,106 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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