DE-117 Spectrum 5 Study

August 8, 2023 updated by: Santen Inc.

An Open-Label, Multicenter Study Assessing the Efficacy and Safety of DE-117 Ophthalmic Solution 0.002% in Latanoprost Low/Non-Responder Subjects Diagnosed With Primary Open-Angle Glaucoma or Ocular Hypertension - Spectrum 5 Study

Santen will evaluate the intraocular pressure (IOP) lowering effect and efficacy of DE-117 ophthalmic solution 0.002% in latanoprost low/non-responder subjects diagnosed with POAG or OHT

Study Overview

Study Type

Interventional

Enrollment (Actual)

107

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

    • Arizona
      • Chandler, Arizona, United States, 85225
        • Arizona Eye Center
    • California
      • Glendale, California, United States, 91204
        • Global Research Management
      • Mission Hills, California, United States, 91345
        • North Valley Eye Medical Group
      • Newport Beach, California, United States, 92663
        • Eye Research Foundation
      • Petaluma, California, United States, 94954
        • North Bay Eye Associates
      • Rancho Cordova, California, United States, 95670
        • Martel Eye Medical Group
    • Connecticut
      • Danbury, Connecticut, United States, 06810
        • Danbury Eye Physicians & Surgeons
    • Florida
      • Largo, Florida, United States, 33773
        • Shettle Eye Research, Inc.
      • Ormond Beach, Florida, United States, 32174
        • International Eye Associates, PA
    • Georgia
      • Albany, Georgia, United States, 31701-2363
        • Dixon Eye Care
      • Morrow, Georgia, United States, 30260
        • Clayton Eye Clinical Research, LLC
      • Roswell, Georgia, United States, 30076
        • Coastal Research Associates, LEC
    • Kansas
      • Shawnee Mission, Kansas, United States, 66204
        • Heart of America Eye Care, P.A.
    • Missouri
      • Saint Louis, Missouri, United States, 63128
        • Tekwani Vision Center
      • Washington, Missouri, United States, 63090
        • Comprehensive Eye Care Ltd
    • New York
      • New York, New York, United States, 10017
        • NYU Langone Health Department of Ophthalmology
      • Rochester, New York, United States, 14618
        • Rochester Ophthalmological Group, PC
      • Wantagh, New York, United States, 14618
        • South Shore Eye Center
    • North Carolina
      • Asheville, North Carolina, United States, 28803
        • Asheville Eye Associates, PLLC
      • Charlotte, North Carolina, United States, 28204
        • Mundorf Eye Center
      • High Point, North Carolina, United States, 27262
        • Cornerstone Health Care
    • Ohio
      • Cincinnati, Ohio, United States, 45242
        • Apex Eye Clinical Research, LLC
      • Cleveland, Ohio, United States, 44115
        • Abrams Eye Center
    • Oklahoma
      • Tulsa, Oklahoma, United States, 74104
        • The Eye Institute
    • Pennsylvania
      • Cranberry Township, Pennsylvania, United States, 16066-6412
        • Scott & Christie and Associates PC
    • South Carolina
      • Mount Pleasant, South Carolina, United States, 29464
        • Glaucoma Consultants and Center for Eye Research, PA
    • Tennessee
      • Memphis, Tennessee, United States, 38120
        • VRF Eye Specialty Group
      • Memphis, Tennessee, United States, 38119
        • Total Eye Care PA
      • Nashville, Tennessee, United States, 37205
        • Nashville Vision Associates
    • Texas
      • Austin, Texas, United States, 78731
        • Texas Eye, PA
      • League City, Texas, United States, 77573
        • Eye Clinic of Texas
      • San Antonio, Texas, United States, 78240
        • Medical Center Ophthalmology Associates

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients with Primary Open-Angle Glaucoma or Ocular Hypertension in one or both eyes.
  • 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 after latanoprost Run-in Period.
  • Qualifying Anterior chamber angle.
  • Qualifying IOP measurement at 3 time-points during latanoprost Run-in Period.

Exclusion Criteria:

  • Patients who cannot safely discontinue use of Ocular Hypotensive Medications during Washout.
  • Patients with prior exposure to DE-117.
  • History of ocular surgery specifically intended to lower IOP
  • 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 Visit 1 (Screening) and throughout the study in either eye.
  • Females who are pregnant, nursing, or planning a pregnancy.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: DE-117 Ophthalmic Solution 0.002%
Interventional treatment will be made with DE-117 Ophthalmic Solution 0.002% once daily in the evening for the duration of the 3 month treatment period.
Interventional treatment will be made with DE-117 Ophthalmic Solution 0.002% once daily in the evening for the duration of the 3 month treatment period.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in Mean Diurnal Intraocular Pressure (IOP) at Month 3.
Time Frame: Month 3
IOP lowering effect of DE-117 ophthalmic solution 0.002% in Latanoprost low/non-responder subjects. Mean Diurnal Intraocular Pressure: Analysis of Change from Baseline in IOP score at Month 3 using Paired T-test on Observed Case. Mean Diurnal IOP is defined as the average IOP of all three timepoints (8:00,12:00, 16:00) at Month 3.
Month 3

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percent Change From Baseline in Mean Diurnal IOP at Week 2, Week 6 and Month 3
Time Frame: week 2, 6 and month 3
The secondary efficacy endpoint evaluated percent change from baseline in mean DIOP at week 2, 6 and month 3.
week 2, 6 and month 3
Change From Baseline in Mean Diurnal IOP at Week 2 and Week 6
Time Frame: week 2 and 6
Change from baseline (Visit 4) in mean diurnal IOP at Week 2 (Visit 5) and Week 6 (Visit 6).
week 2 and 6
Change From Baseline in IOP at Timepoints at Week 2
Time Frame: 08:00, 12:00 and 16:00 at Week 2
Change in mean IOP were evaluated at each time point at all post-baseline visits. (Change from baseline measurement at each timepoint was calculated by deducting the baseline value at corresponding timepoint from the IOP measurement).
08:00, 12:00 and 16:00 at Week 2
Change From Baseline in IOP at Timepoints at Week 6
Time Frame: 08:00, 12:00 and 16:00 at Week 6
Change in mean IOP were evaluated at each time point at all post-baseline visits.
08:00, 12:00 and 16:00 at Week 6
Change From Baseline in IOP at Timepoints at Month 3
Time Frame: 08:00, 12:00 and 16:00 at month 3
Change in mean IOP were evaluated at each time point at all post-baseline visits.
08:00, 12:00 and 16:00 at month 3
Intraocular Pressure: Percent Change From Baseline by Analysis Visit and Timepoint at Week 2
Time Frame: 08:00, 12:00 and 16:00 at week 2
Intraocular Pressure: Percent Change from Baseline by Analysis Visit and Timepoint.
08:00, 12:00 and 16:00 at week 2
Intraocular Pressure: Percent Change From Baseline by Analysis Visit and Timepoint at Week 6
Time Frame: 08:00, 12:00 and 16:00 at week 6
Intraocular Pressure: Percent Change from Baseline by Analysis Visit and Timepoint.
08:00, 12:00 and 16:00 at week 6
Intraocular Pressure: Percent Change From Baseline by Analysis Visit and Timepoint at Month 3
Time Frame: 08:00, 12:00 and 16:00 at month 3.
Intraocular Pressure: Percent Change from Baseline by Analysis Visit and Timepoint.
08:00, 12:00 and 16:00 at month 3.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 27, 2018

Primary Completion (Actual)

January 13, 2022

Study Completion (Actual)

January 13, 2022

Study Registration Dates

First Submitted

October 3, 2018

First Submitted That Met QC Criteria

October 3, 2018

First Posted (Actual)

October 5, 2018

Study Record Updates

Last Update Posted (Actual)

August 30, 2023

Last Update Submitted That Met QC Criteria

August 8, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Primary Open-angle Glaucoma and Ocular Hypertension

Clinical Trials on DE-117 Ophthalmic Solution

3
Subscribe