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

Ocular Hypertension Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02083289
• Other study ID #: ONO-9054IOU003
• Status: Completed
• Phase: Phase 2
• First received: March 6, 2014
• Last updated: January 26, 2016
• Start date: May 2014

Study information

• Verified date: January 2016
• Source: Ono Pharmaceutical Co. Ltd
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 123
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Glaucoma
• Glaucoma, Open-Angle
• Hypertension
• Ocular Hypertension
• Open Angle-glaucoma

Intervention

Drug:
• ONO-9054

• Latanoprost

Locations

Country	Name	City	State
United States	Austin Clinical Site	Austin	Texas
United States	Cranberry Township Clinical Site	Cranberry Township	Pennsylvania
United States	High Point Clinical Site	High Point	North Carolina
United States	Los Angeles Clinical Site	Los Angeles	California
United States	Mission Hills Clinical Site	Mission Hills	California
United States	Morrow Clinical Site	Morrow	Georgia
United States	New York Clinical Site	New York	New York
United States	Newport Beach Clinical Site	Newport Beach	California
United States	Pasadena Clinical Site	Pasadena	California
United States	Petaluma Clinical Site	Petaluma	California
United States	Philadelphia Clinical Site	Philadelphia	Pennsylvania
United States	Roswell Clinical Site	Roswell	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
Ono Pharmaceutical Co. Ltd

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean change in diurnal IOP (average of four time points) from baseline		28 days	No
Primary	Evaluating the safety parameters per protocol	Physical and ocular examinations (tolerability, hyperemia, visual acuity, pupillometry, corneal thickness, aqueous cells and flare), vital signs, and safety laboratory evaluations	28 days	Yes
Secondary	Diurnal IOP		28 days	No
Secondary	Mean change from baseline in IOP at each measured time point		28 days	No
Secondary	Treatment response rates		28 days	No
Secondary	Percent change from baseline in IOP at each measured time point		28 days	No