Study Assessing the Safety and Efficacy of DE-117 Ophthalmic Solution Once Daily and Twice Daily in Subjects With Primary Open-Angle Glaucoma SPECTRUM 6

A Randomized, Double-Masked, Parallel-Group, Multicenter Study Assessing the Safety and Efficacy of DE-117 Ophthalmic Solution 0.002% Once Daily and Twice Daily in Subjects With Primary Open-Angle Glaucoma or Ocular Hypertension SPECTRUM 6 Study.

This is a randomized, double-masked, parallel-group, multi-center study. Subjects diagnosed with POAG or OHT who meet eligibility criteria at Visit 1 (Screening) will wash out their current topical IOP lowering medication(s), if any. After completing the required washout period, subjects will return for Visit 2 (Baseline, Day 1). Subjects who meet all eligibility criteria at Visit 2 (Baseline, Day 1) will be randomized to receive study medication for up to 6 weeks.

Approximately 100 subjects with POAG or OHT will be randomized in a 1:1 ratio to either:

• DE-117 ophthalmic solution 0.002% QD (Once Daily)
• DE-117 ophthalmic solution 0.002% BID (Twice Daily)

This study will consist of a screening period of up to 35 days including a washout period of up to 28 days (+ 7 days window), and a 6-week double-masked treatment period.

Study Overview

• Status: Completed
• Conditions: Primary Open-angle Glaucoma and Ocular Hypertension
• Intervention / Treatment: Drug: DE-117 Ophthalmic Solution QD; Drug: DE-117 Ophthalmic Solution BID

• Study Type: Interventional
• Enrollment (Actual): 98
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90013
      • East West Eye Institute
  • Connecticut
    • Danbury, Connecticut, United States, 06810
      • Danbury Eye Specialist
  • Florida
    • Brooksville, Florida, United States, 34613
      • Hernando Eye Institute
    • Jacksonville, Florida, United States, 32204
      • Levenson Eye Associates
  • Maryland
    • Havre De Grace, Maryland, United States, 21078
      • Seidenberg Protzko Eye Associates
  • Missouri
    • Saint Louis, Missouri, United States, 63128
      • Tekwani Vision Center
  • New Jersey
    • Vineland, New Jersey, United States, 08361
      • Eye Associates/SurgiCenter of Vineland
  • New York
    • Lynbrook, New York, United States, 11563
      • Ophthalmic Consultants of Long Island
  • Ohio
    • Cincinnati, Ohio, United States, 45242
      • Apex Eye Clinical Research, LLC
    • Cleveland, Ohio, United States, 44115
      • Abrams Eye Center
  • Pennsylvania
    • Cranberry Township, Pennsylvania, United States, 16066
      • Scott & Christie and Associates PC
  • Tennessee
    • Maryville, Tennessee, United States, 37803
      • University Eye Specialist
    • Nashville, Tennessee, United States, 37205
      • Advanced Vision Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

Provide signed written informed consent

• Have a diagnosis of POAG or OHT in both eyes, or one eye with POAG and the other with OHT.
• 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 180 days prior to Screening and throughout the study in either eye
• Females who are pregnant, nursing, or planning a pregnancy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Drug Arm: DE-117 QD; DE-117 Ophthalmic Solution QD (20:00) and Vehicle (8:00; no active DE-117 ingredient) QD	Drug: DE-117 Ophthalmic Solution QD; DE-117 ophthalmic solution QD and Vehicle (no active DE-117 ingredient) QD add one drop in each eye
Experimental: Test Arm: DE-117 BID; DE-117 Ophthalmic Solution BID Twice daily (20:00 and 8:00)	Drug: DE-117 Ophthalmic Solution BID; DE-117 ophthalmic solution BID twice Daily (20:00 and 8:00) add one drop in each eye

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intraocular Pressure (IOP) at Week 2	Intraocular pressure (IOP), the fluid pressure inside the eye, was measured by applanation tonometry in millimeters mercury (mmHg).	08:00 at week 2
Intraocular Pressure (IOP) at Week 2	Intraocular pressure (IOP), the fluid pressure inside the eye, was measured by applanation tonometry in millimeters mercury (mmHg).	12:00 at week 2
Intraocular Pressure (IOP) at Week 2	Intraocular pressure (IOP), the fluid pressure inside the eye, was mea...	16:00 at week 2
Intraocular Pressure (IOP) at Week 6	Intraocular pressure (IOP), the fluid pressure inside the eye, was measured by applanation tonometry in millimeters mercury (mmHg).	08:00 at week 6
Intraocular Pressure (IOP) at Week 6	Intraocular pressure (IOP), the fluid pressure inside the eye, was measured by applanation tonometry in millimeters mercury (mmHg).	12:00 at week 6
Intraocular Pressure (IOP) at Week 6	Intraocular pressure (IOP), the fluid pressure inside the eye, was mea...	16:00 at week 6

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Diurnal Intraocular Pressure (IOP)	Intraocular pressure (IOP), the fluid pressure inside the eye, was measured by applanation tonometry in millimeters mercury (mmHg).	6 weeks

Collaborators and Investigators

• Sponsor: Santen Inc.

Study record dates

Study Major Dates

• Study Start (Actual): January 28, 2019
• Primary Completion (Actual): June 20, 2019
• Study Completion (Actual): June 20, 2019

Study Registration Dates

• First Submitted: February 27, 2019
• First Submitted That Met QC Criteria: February 27, 2019
• First Posted (Actual): March 1, 2019

Study Record Updates

• Last Update Posted (Actual): August 4, 2020
• Last Update Submitted That Met QC Criteria: July 20, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Eye Diseases; Glaucoma; Glaucoma, Open-Angle; Ocular Hypertension; Hypertension; Ophthalmic Solutions; Pharmaceutical Solutions
• Other Study ID Numbers: 011712IN

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No