Single and Multiple Dose Escalation and Two-sequence Crossover Study of ONO-9054 in Patients With Ocular Hypertension or Mild Open-angle Glaucoma

Ono Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Mild Open Angle-glaucoma (OAG); Ocular Hypertension (OHT)

Treatments: Drug: Placebo; Drug: ONO-9054

Study type: Interventional

Funder types: Industry

Identifiers

NCT01670266

ONO-9054IOU002

Details and patient eligibility

About

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.

Enrollment: 60 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 5 patient groups, including a placebo group

Experimental Arm 1

Experimental group

Description:

Experimental Eye drops 3.0 µg/mL QD both eyes on Day 1, 5-18

Treatment:

Drug: ONO-9054

Experimental Arm 2

Experimental group

Description:

Experimental Eye drops 10.0 µg/mL QD both eyes on Day 1, 5-18

Treatment:

Drug: ONO-9054

Experimental Arm 3

Experimental group

Description:

Experimental Eye drop 30.0 µg/mL QD both eyes on day 1, 5-18

Treatment:

Drug: ONO-9054

Experimental Arm 4

Experimental group

Description:

Experimental Eye drop, 2 sequence crossover Cohort \[1 dose; 1-30 µg/mL\]to be determined and placebo

Treatment:

Drug: Placebo

Drug: ONO-9054

Placebo Arm

Placebo Comparator group

Description:

Matched placebo eye drops dosed in same manner as ONO-9054

Treatment:

Drug: Placebo