Overview

This trial is active, not recruiting.

Conditions ocular hypertension, open angle-glaucoma
Treatments ono-9054, latanoprost
Phase phase 2
Sponsor Ono Pharmaceutical Co. Ltd
Start date May 2014
End date December 2014
Trial size 108 participants
Trial identifier NCT02083289, ONO-9054IOU003

Summary

The primary objectives of this study are to compare the safety, tolerability, and mean change from baseline in diurnal intraocular pressure (IOP) of ONO-9054 30 µg/mL (0.003%) to latanoprost 0.005% following ocular instillation once every evening for 28 days.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking double blind (subject, investigator)
Primary purpose treatment
Arm
(Experimental)
ONO-9054 eye drop solution, 30 µg/mL (0.003%), once daily in both eyes, for 28 days.
ono-9054
(Active Comparator)
Latanoprost eye drop solution, 0.005%, once daily in both eyes for 28 days.
latanoprost Xalatan®

Primary Outcomes

Measure
Mean change in diurnal IOP (average of four time points) from baseline
time frame: 28 days
Evaluating the safety parameters per protocol
time frame: 28 days

Secondary Outcomes

Measure
Diurnal IOP
time frame: 28 days
Mean change from baseline in IOP at each measured time point
time frame: 28 days
Treatment response rates
time frame: 28 days
Percent change from baseline in IOP at each measured time point
time frame: 28 days

Eligibility Criteria

Male or female participants from 18 years up to 85 years old.

Inclusion Criteria: - Male or female aged 18-85 (inclusive) with confirmed diagnosis of OHT or OAG - Confirmed diagnosis of bilateral OHT or mild to moderate chronic OAG - Able to undergo washout of all ocular drugs - An IOP ≥ 24 mmHg at 8:00 AM and ≥ 21 mmHg at 10:00 AM in at least 1 eye; but < 36 mmHg in both eyes at both Day -5 and Day 1 - Central corneal thickness 500-620 µm at screening and Day -5 in both eyes - Best corrected visual acuity (BCVA) of +0.7 Log Mar or better Exclusion Criteria: - Any history of severe ocular trauma in either eye at any time - History of angle closure 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 or photography of the fundus in either eye

Additional Information

Official title A 28-day Double-masked, Randomized, Parallel-group, Active Controlled Study of ONO-9054 Ophthalmic Solution in Subjects With Ocular Hypertension (OHT) or Open-angle Glaucoma (OAG)
Trial information was received from ClinicalTrials.gov and was last updated in November 2014.
Information provided to ClinicalTrials.gov by Ono Pharmaceutical Co. Ltd.