A Phase IIb Safety and Efficacy Study of DE-126 Ophthalmic Solution in Primary Open-Angle Glaucoma or Ocular Hypertension- Angel Study

Open-angle Glaucoma, Ocular Hypertension Clinical Trial

Official title:

A Phase IIb, Randomized, Observer-Masked, Placebo- and Active-Controlled, Parallel-Group, Multinational and Multicenter Study Assessing the Safety and Efficacy of DE-126 Ophthalmic Solution in Subjects With Primary Open-Angle Glaucoma or Ocular Hypertension- Angel Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03216902
• Other study ID #: 012601IN
• Status: Completed
• Phase: Phase 2
• Start date: July 25, 2017
• Est. completion date: February 27, 2018

Study information

• Verified date: September 2020
• Source: Santen Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Treatment of elevated pressure in the eye (Intraocular pressure, or 'IOP') with eye drop medications has been shown to be effective in delaying or preventing the progression of glaucoma, and it is the only proven method for reducing the risk of glaucomatous visual field loss. This study is being conducted to determine how well DE-126 ophthalmic solution works (efficacy) in safely lowering IOP when dosed as topical eyedrops. This study will evaluate the safety and efficacy of four (4) concentrations of DE-126, when compared with latanoprost (0.005%) eye drops in patients with primary open-angle glaucoma or ocular hypertension. The IOP will be measured at 3 different times throughout the day, over 6 total visits during a 3-month treatment period (with up to 4 extra weeks observation if the patient must stop taking current eye drops to lower IOP). Safety assessments will be done throughout the study, including ocular signs and symptoms, vital signs, and clinical laboratory tests. While the most important time-point to measure IOP in this study and evaluate efficacy will be at the final study visit (month 3), IOP values will also be evaluated at other visits throughout the 3-month treatment period.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 241
• Est. completion date: February 27, 2018
• Est. primary completion date: February 27, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Provide signed written informed consent
• Diagnosis of POAG or OHT in both eyes
• Qualifying corrected visual acuity in each eye
• Qualifying central corneal thickness in each eye
• Qualifying Day 1 IOP measurement at 3 time-points in both eyes
• Qualifying Anterior chamber angle

Exclusion Criteria:

• History of ocular surgery specifically intended to lower IOP
• Subjects who cannot safely discontinue use of ocular hypotensive medications during the wait/washout period
• Advanced glaucoma in either eye
• Any corneal abnormality or other condition interfering with or preventing reliable Goldmann applanation tonometry
• Any ocular surgery or ocular laser treatment within 90 days prior to Visit 1 (Screening) and throughout the study in either eye
• Females who are pregnant, nursing, or planning a pregnancy

Related Conditions & MeSH terms

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

Intervention

Drug:
• Vehicle of DE-126 Ophthalmic Solution, high dose of DE-126 Ophthalmic Solution
Vehicle of DE-126 Ophthalmic Solution dosed once daily for 6weeks, followed by high dose of DE-126 dosed once daily for 6 additional weeks
• Topical ultra-low dose of DE-126 Ophthalmic Solution
Topical ultra-low dose of DE-126 Ophthalmic Solution dosed once daily for 12 weeks
• Topical low dose of DE-126 Ophthalmic Solution
Topical low dose of DE-126 Ophthalmic Solution dosed once daily for 12 weeks
• Topical medium dose of DE-126 Ophthalmic Solution
Topical medium dose of DE-126 Ophthalmic Solution dosed once daily for 12 weeks
• Topical high dose of DE-126 Ophthalmic Solution
Topical high dose of DE-126 Ophthalmic Solution dosed once daily for 12 weeks
• 0.005% Latanoprost Ophthalmic Solution
0.005% Latanoprost Ophthalmic Solution dosed once daily for 12 weeks

Locations

Country	Name	City	State
Japan	Murakami Karindoh Hospital	Fukuoka-shi, Fukuoka
Japan	Nagasaka Eye Clinic	Nagoya-shi, Aichi
Japan	Sugiura Eye Clinic	Osaka-shi, Osaka
Japan	Sapporo Katoh Ophthalmology Clinic	Sapporo-shi, Hokkaido
Japan	Dogenzaka Kato Eye Clinic	Shibuya-ku, Tokyo
United States	Sall Research Medical Center, Inc	Artesia	California
United States	Keystone Research Ltd SMO/Texan Eye, PA	Austin	Texas
United States	Mundorf Eye Center	Charlotte	North Carolina
United States	Cornerstone Health Care, LLC	High Point	North Carolina
United States	Shettle Eye Research, Inc.	Largo	Florida
United States	North Valley Eye Medical Group	Mission Hills	California
United States	Clayton Eye Clinical Research, LLC	Morrow	Georgia
United States	Eye Research Foundation, INC	Newport Beach	California
United States	North Bay Eye Associates, Inc.	Petaluma	California
United States	Rochester Ophthalmological Group, PC	Rochester	New York
United States	Coastal Research Associates, LLC	Roswell	Georgia
United States	Keystone Research LTD SMO/Medical Center Ophthalmology Assoc.	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Santen Inc.

Countries where clinical trial is conducted

United States,  Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intraocular Pressure in the Study Eye at Month 3	Intraocular Pressure (IOP),the fluid pressure inside the eye was measured by the Goldmann applanation tonometer in millimeters mercury (mmHg) at 3 time-points throughout the day.	9:00, 13:00 and 17:00 at Month 3
Secondary	Intraocular Pressure in the Study Eye at Week 6	Intraocular Pressure (IOP),the fluid pressure inside the eye was measured by the Goldmann applanation tonometer in millimeters mercury (mmHg) at 3 time-points throughout the day.	9:00, 13:00 and 17:00 at Week 6
Secondary	Intraocular Pressure in the Study Eye at Week 1 and Week 2	Intraocular Pressure (IOP),the fluid pressure inside the eye was measured by the Goldmann applanation tonometer in millimeters mercury (mmHg) at 3 time-points throughout the day.	9:00, 13:00 and 17:00 at Week 1 and Week 2
Secondary	Mean Diurnal Intraocular Pressure in the Study Eye at Each Post-baseline Visit	Mean Diurnal IOP was defined as the mean of the IOP values at the three schedules timepoints (9:00, 13:00 and 17:00) at that visit for that subject.	Week 1, Week 2, Week 6 and Month 3.
Secondary	Change From Baseline (CFB) in Mean Diurnal Intraocular Pressure in the Study Eye at Each Post-baseline Visit	Mean Diurnal IOP was defined as the mean of the IOP values at the three schedules timepoints (9:00, 13:00 and 17:00) at that visit for that subject.	Week 1, Week 2, Week 6 and Month 3.
Secondary	Percent Change From Baseline (CFB) in Mean Diurnal Intraocular Pressure in the Study Eye at Each Post-baseline Visit	Mean Diurnal IOP was defined as the mean of the IOP values at the three schedules timepoints (9:00, 13:00 and 17:00) at that visit for that subject.	Week 1, Week 2, Week 6 and Month 3.
Secondary	Change From Baseline (CFB) in Intraocular Pressure in the Study Eye at Three Time Points at Each Post-baseline Visit	Intraocular Pressure (IOP),the fluid pressure inside the eye was measured by the Goldmann applanation tonometer in millimeters mercury (mmHg) at 3 time-points throughout the day.	9:00, 13:00 and 17:00 at Week 1, Week 2, Week 6 and Month 3.
Secondary	Percent Change From Baseline (CFB) in Intraocular Pressure in the Study Eye at Three Time Points at Each Post-baseline Visit	Intraocular Pressure (IOP),the fluid pressure inside the eye was measured by the Goldmann applanation tonometer in millimeters mercury (mmHg) at 3 time-points throughout the day.	9:00, 13:00 and 17:00 at Week 1, Week 2, Week 6 and Month 3.
Secondary	Percentage of Subjects With Mean Diurnal Intraocular Pressure Reduction From Baseline = 20%, 25% and 30% in the Study Eye at Each Post-baseline Visit	A Subject was a responder if the percent reduction from baseline in mean diurnal IOP in the study eye was = 20%.; A Subject was a responder if the percent reduction from baseline in mean diurnal IOP in the study eye was = 25%.; A Subject was a responder if the percent reduction from baseline in mean diurnal IOP in the study eye was = 30%.	WeeK 1, Week 2, Week 6 and Month 3.
Secondary	Percentage of Subjects With Mean Diurnal Intraocular Pressure = 18 mmHg in the Study Eye at Each Post-baseline Visit	A subject was a responder if the mean diurnal IOP in the study eye was = 18 mmHg.	Week 1, Week 2, Week 6 and Month 3.