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Completed

NCT Number: NCT02083289

A 28 Day Study of ONO-9054 Ophthalmic Solution in Subjects With Ocular Hypertension (OHT) or Open-angle Glaucoma (OAG)

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.

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Key information

Conditions

Ocular Hypertension Eye Diseases Glaucoma Glaucoma, Open-Angle Open Angle-glaucoma

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Los Angeles Clinical Site, Los Angeles, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ONO-9054

Drug

latanoprost

Drug

Other names: Xalatan®

Primary outcomes

  1. Mean change in diurnal IOP (average of four time points) from baseline

    Time frame: 28 days

  2. Evaluating the safety parameters per protocol

    Time frame: 28 days

    Physical and ocular examinations (tolerability, hyperemia, visual acuity, pupillometry, corneal thickness, aqueous cells and flare), vital signs, and safety laboratory evaluations

Secondary outcomes

  1. Diurnal IOP

    Time frame: 28 days

  2. Mean change from baseline in IOP at each measured time point

    Time frame: 28 days

  3. Treatment response rates

    Time frame: 28 days

  4. Percent change from baseline in IOP at each measured time point

    Time frame: 28 days

Sponsors and collaborators

Lead sponsor

Ono Pharmaceutical Co., Ltd.

Industry

Registry information

Official study 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)

Important dates

Study start
2014
Primary completion
2014
First posted
Mar 11, 2014
Registry last updated
Feb 25, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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