Single and Multiple Dose Escalation and Two-sequence Crossover Study of ONO-9054 in Patients With Ocular Hypertension or Mild Open-angle Glaucoma
Completed · Phase 1 · Has a placebo group
Conditions studied: Ocular Hypertension (OHT), Mild Open Angle-glaucoma (OAG)
In brief
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.
Key facts
- Study ID
- NCT01670266
- Run by
- Ono Pharma USA Inc
- People needed
- 60
- Starts
- 2012-08-01
- Last updated by the study team
- 2013-06-03
Who can join
Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Male or female subjects age 18-80 (inclusive) with confirmed diagnosis of OHT or OAG
- Confirmed diagnosis of bilateral OHT or chronic open-angle glaucoma
- Able to undergo washout of all ocular drugs
- An IOP ≥ 22mmHg at 8:00 AM and ≥ 21 mmHg at 10:00 AM in at least one eye; but ≤ 35 mmHg at all time points in both eyes on Day -2 and Day -1
- Central corneal thickness 500-600 µm at screening in both eyes
- BCVA 20/100 or better in both eyes
You may not qualify if…
- Any history of severe ocular trauma in either eye at any time
- Any history of previous intraocular or ocular laser surgery within the past 3 months or any refractive surgery procedure within the past 6 months of screening visit in the study eye(s)
- Cataracts that prevent observation of the fundus in either eye
Where it is running
- Costa Mesa Clinical Site — Costa Mesa, California, United States
- Newport Beach (satellite site) — Newport Beach, California, United States
- Santa Ana (satellite site) — Santa Ana, California, United States
Full record on ClinicalTrials.gov
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