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

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ClinicalTrials.gov Identifier: NCT02083289
Recruitment Status : Completed
First Posted : March 11, 2014
Last Update Posted : February 25, 2016
Sponsor:
Information provided by (Responsible Party):
Ono Pharmaceutical Co. Ltd

Brief 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.

Condition or disease Intervention/treatment Phase
Ocular Hypertension Open Angle-glaucoma Drug: ONO-9054 Drug: Latanoprost Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 123 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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)
Study Start Date : May 2014
Actual Primary Completion Date : December 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma
Drug Information available for: Latanoprost

Arm Intervention/treatment
Experimental: Experimental Arm 1
ONO-9054 eye drop solution, 30 µg/mL (0.003%), once daily in both eyes, for 28 days.
Drug: ONO-9054
Active Comparator: Active Comparator Arm 2
Latanoprost eye drop solution, 0.005%, once daily in both eyes for 28 days.
Drug: Latanoprost
Other Name: Xalatan®




Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02083289


Locations
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United States, California
Los Angeles Clinical Site
Los Angeles, California, United States, 90048
Mission Hills Clinical Site
Mission Hills, California, United States, 91345
Newport Beach Clinical Site
Newport Beach, California, United States, 92663
Pasadena Clinical Site
Pasadena, California, United States, 91105
Petaluma Clinical Site
Petaluma, California, United States, 94954
United States, Georgia
Morrow Clinical Site
Morrow, Georgia, United States, 30260
Roswell Clinical Site
Roswell, Georgia, United States, 30076
United States, New York
New York Clinical Site
New York, New York, United States, 10029
United States, North Carolina
High Point Clinical Site
High Point, North Carolina, United States, 27262
United States, Pennsylvania
Cranberry Township Clinical Site
Cranberry Township, Pennsylvania, United States, 16066
Philadelphia Clinical Site
Philadelphia, Pennsylvania, United States, 19104
United States, Texas
Austin Clinical Site
Austin, Texas, United States, 78731
Sponsors and Collaborators
Ono Pharmaceutical Co. Ltd
Investigators
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Study Director: Ono Pharmaceutical Co., Ltd. Ono Pharmaceutical Co. Ltd
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Ono Pharmaceutical Co. Ltd
ClinicalTrials.gov Identifier: NCT02083289    
Other Study ID Numbers: ONO-9054IOU003
First Posted: March 11, 2014    Key Record Dates
Last Update Posted: February 25, 2016
Last Verified: January 2016
Keywords provided by Ono Pharmaceutical Co. Ltd:
ONO-9054
ocular hypertension (OHT)
Open angle-glaucoma (OAG)
Glaucoma
Eye Diseases
Mild to moderate
Additional relevant MeSH terms:
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Glaucoma
Glaucoma, Open-Angle
Ocular Hypertension
Hypertension
Vascular Diseases
Cardiovascular Diseases
Eye Diseases
Latanoprost
Ophthalmic Solutions
Pharmaceutical Solutions