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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE March 6, 2014
First Posted Date  ICMJE March 11, 2014
Last Update Posted Date February 25, 2016
Study Start Date  ICMJE May 2014
Actual Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 7, 2014)
  • 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 ]
    Physical and ocular examinations (tolerability, hyperemia, visual acuity, pupillometry, corneal thickness, aqueous cells and flare), vital signs, and safety laboratory evaluations
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 7, 2014)
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A 28 Day Study of ONO-9054 Ophthalmic Solution in Subjects With Ocular Hypertension (OHT) or Open-angle Glaucoma (OAG)
Official Title  ICMJE 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)
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Ocular Hypertension
  • Open Angle-glaucoma
Intervention  ICMJE
  • Drug: ONO-9054
  • Drug: Latanoprost
    Other Name: Xalatan®
Study Arms  ICMJE
  • Experimental: Experimental Arm 1
    ONO-9054 eye drop solution, 30 µg/mL (0.003%), once daily in both eyes, for 28 days.
    Intervention: Drug: ONO-9054
  • Active Comparator: Active Comparator Arm 2
    Latanoprost eye drop solution, 0.005%, once daily in both eyes for 28 days.
    Intervention: Drug: Latanoprost
Publications * Miller Ellis E, Berlin MS, Ward CL, Sharpe JA, Jamil A, Harris A. Ocular hypotensive effect of the novel EP3/FP agonist ONO-9054 versus Xalatan: results of a 28-day, double-masked, randomised study. Br J Ophthalmol. 2017 Jun;101(6):796-800. doi: 10.1136/bjophthalmol-2016-309023. Epub 2016 Sep 20.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 19, 2014)
123
Original Estimated Enrollment  ICMJE
 (submitted: March 7, 2014)
108
Study Completion Date  ICMJE Not Provided
Actual Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02083289
Other Study ID Numbers  ICMJE ONO-9054IOU003
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Ono Pharmaceutical Co. Ltd
Study Sponsor  ICMJE Ono Pharmaceutical Co. Ltd
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Ono Pharmaceutical Co., Ltd. Ono Pharmaceutical Co. Ltd
PRS Account Ono Pharmaceutical Co. Ltd
Verification Date January 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP