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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

Primary Purpose

Primary Open-angle Glaucoma and Ocular Hypertension

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
DE-117 Ophthalmic Solution QD
DE-117 Ophthalmic Solution BID
Sponsored by
Santen Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Primary Open-angle Glaucoma and Ocular Hypertension

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • East West Eye Institute
  • Danbury Eye Specialist
  • Hernando Eye Institute
  • Levenson Eye Associates
  • Seidenberg Protzko Eye Associates
  • Tekwani Vision Center
  • Eye Associates/SurgiCenter of Vineland
  • Ophthalmic Consultants of Long Island
  • Apex Eye Clinical Research, LLC
  • Abrams Eye Center
  • Scott & Christie and Associates PC
  • University Eye Specialist
  • Advanced Vision Research

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Drug Arm: DE-117 QD

Test Arm: DE-117 BID

Arm Description

DE-117 Ophthalmic Solution QD (20:00) and Vehicle (8:00; no active DE-117 ingredient) QD

DE-117 Ophthalmic Solution BID Twice daily (20:00 and 8:00)

Outcomes

Primary Outcome Measures

Intraocular Pressure (IOP) at Week 2
Intraocular pressure (IOP), the fluid pressure inside the eye, was measured by applanation tonometry in millimeters mercury (mmHg).
Intraocular Pressure (IOP) at Week 2
Intraocular pressure (IOP), the fluid pressure inside the eye, was measured by applanation tonometry in millimeters mercury (mmHg).
Intraocular Pressure (IOP) at Week 2
Intraocular pressure (IOP), the fluid pressure inside the eye, was mea...
Intraocular Pressure (IOP) at Week 6
Intraocular pressure (IOP), the fluid pressure inside the eye, was measured by applanation tonometry in millimeters mercury (mmHg).
Intraocular Pressure (IOP) at Week 6
Intraocular pressure (IOP), the fluid pressure inside the eye, was measured by applanation tonometry in millimeters mercury (mmHg).
Intraocular Pressure (IOP) at Week 6
Intraocular pressure (IOP), the fluid pressure inside the eye, was mea...

Secondary Outcome Measures

Mean Diurnal Intraocular Pressure (IOP)
Intraocular pressure (IOP), the fluid pressure inside the eye, was measured by applanation tonometry in millimeters mercury (mmHg).

Full Information

First Posted
February 27, 2019
Last Updated
July 20, 2020
Sponsor
Santen Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03858894
Brief Title
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
Official Title
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.
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
January 28, 2019 (Actual)
Primary Completion Date
June 20, 2019 (Actual)
Study Completion Date
June 20, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Santen Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Open-angle Glaucoma and Ocular Hypertension

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
98 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Drug Arm: DE-117 QD
Arm Type
Experimental
Arm Description
DE-117 Ophthalmic Solution QD (20:00) and Vehicle (8:00; no active DE-117 ingredient) QD
Arm Title
Test Arm: DE-117 BID
Arm Type
Experimental
Arm Description
DE-117 Ophthalmic Solution BID Twice daily (20:00 and 8:00)
Intervention Type
Drug
Intervention Name(s)
DE-117 Ophthalmic Solution QD
Intervention Description
DE-117 ophthalmic solution QD and Vehicle (no active DE-117 ingredient) QD add one drop in each eye
Intervention Type
Drug
Intervention Name(s)
DE-117 Ophthalmic Solution BID
Intervention Description
DE-117 ophthalmic solution BID twice Daily (20:00 and 8:00) add one drop in each eye
Primary Outcome Measure Information:
Title
Intraocular Pressure (IOP) at Week 2
Description
Intraocular pressure (IOP), the fluid pressure inside the eye, was measured by applanation tonometry in millimeters mercury (mmHg).
Time Frame
08:00 at week 2
Title
Intraocular Pressure (IOP) at Week 2
Description
Intraocular pressure (IOP), the fluid pressure inside the eye, was measured by applanation tonometry in millimeters mercury (mmHg).
Time Frame
12:00 at week 2
Title
Intraocular Pressure (IOP) at Week 2
Description
Intraocular pressure (IOP), the fluid pressure inside the eye, was mea...
Time Frame
16:00 at week 2
Title
Intraocular Pressure (IOP) at Week 6
Description
Intraocular pressure (IOP), the fluid pressure inside the eye, was measured by applanation tonometry in millimeters mercury (mmHg).
Time Frame
08:00 at week 6
Title
Intraocular Pressure (IOP) at Week 6
Description
Intraocular pressure (IOP), the fluid pressure inside the eye, was measured by applanation tonometry in millimeters mercury (mmHg).
Time Frame
12:00 at week 6
Title
Intraocular Pressure (IOP) at Week 6
Description
Intraocular pressure (IOP), the fluid pressure inside the eye, was mea...
Time Frame
16:00 at week 6
Secondary Outcome Measure Information:
Title
Mean Diurnal Intraocular Pressure (IOP)
Description
Intraocular pressure (IOP), the fluid pressure inside the eye, was measured by applanation tonometry in millimeters mercury (mmHg).
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
East West Eye Institute
City
Los Angeles
State/Province
California
ZIP/Postal Code
90013
Country
United States
Facility Name
Danbury Eye Specialist
City
Danbury
State/Province
Connecticut
ZIP/Postal Code
06810
Country
United States
Facility Name
Hernando Eye Institute
City
Brooksville
State/Province
Florida
ZIP/Postal Code
34613
Country
United States
Facility Name
Levenson Eye Associates
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32204
Country
United States
Facility Name
Seidenberg Protzko Eye Associates
City
Havre De Grace
State/Province
Maryland
ZIP/Postal Code
21078
Country
United States
Facility Name
Tekwani Vision Center
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63128
Country
United States
Facility Name
Eye Associates/SurgiCenter of Vineland
City
Vineland
State/Province
New Jersey
ZIP/Postal Code
08361
Country
United States
Facility Name
Ophthalmic Consultants of Long Island
City
Lynbrook
State/Province
New York
ZIP/Postal Code
11563
Country
United States
Facility Name
Apex Eye Clinical Research, LLC
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45242
Country
United States
Facility Name
Abrams Eye Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44115
Country
United States
Facility Name
Scott & Christie and Associates PC
City
Cranberry Township
State/Province
Pennsylvania
ZIP/Postal Code
16066
Country
United States
Facility Name
University Eye Specialist
City
Maryville
State/Province
Tennessee
ZIP/Postal Code
37803
Country
United States
Facility Name
Advanced Vision Research
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37205
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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