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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03858894
Recruitment Status : Completed
First Posted : March 1, 2019
Results First Posted : August 4, 2020
Last Update Posted : August 4, 2020
Sponsor:
Information provided by (Responsible Party):
Santen Inc.

Study Description
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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.


Condition or disease Intervention/treatment Phase
Primary Open-angle Glaucoma and Ocular Hypertension Drug: DE-117 Ophthalmic Solution QD Drug: DE-117 Ophthalmic Solution BID Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 98 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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.
Actual Study Start Date : January 28, 2019
Actual Primary Completion Date : June 20, 2019
Actual Study Completion Date : June 20, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma

Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Intraocular Pressure (IOP) at Week 2 [ Time Frame: 08:00 at week 2 ]
    Intraocular pressure (IOP), the fluid pressure inside the eye, was measured by applanation tonometry in millimeters mercury (mmHg).

  2. Intraocular Pressure (IOP) at Week 2 [ Time Frame: 12:00 at week 2 ]
    Intraocular pressure (IOP), the fluid pressure inside the eye, was measured by applanation tonometry in millimeters mercury (mmHg).

  3. Intraocular Pressure (IOP) at Week 2 [ Time Frame: 16:00 at week 2 ]
    Intraocular pressure (IOP), the fluid pressure inside the eye, was mea...

  4. Intraocular Pressure (IOP) at Week 6 [ Time Frame: 08:00 at week 6 ]
    Intraocular pressure (IOP), the fluid pressure inside the eye, was measured by applanation tonometry in millimeters mercury (mmHg).

  5. Intraocular Pressure (IOP) at Week 6 [ Time Frame: 12:00 at week 6 ]
    Intraocular pressure (IOP), the fluid pressure inside the eye, was measured by applanation tonometry in millimeters mercury (mmHg).

  6. Intraocular Pressure (IOP) at Week 6 [ Time Frame: 16:00 at week 6 ]
    Intraocular pressure (IOP), the fluid pressure inside the eye, was mea...


Secondary Outcome Measures :
  1. Mean Diurnal Intraocular Pressure (IOP) [ Time Frame: 6 weeks ]
    Intraocular pressure (IOP), the fluid pressure inside the eye, was measured by applanation tonometry in millimeters mercury (mmHg).


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03858894


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

Documents provided by Santen Inc.:
Study Protocol  [PDF] November 13, 2018
Statistical Analysis Plan  [PDF] July 11, 2019

More Information
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Responsible Party: Santen Inc.
ClinicalTrials.gov Identifier: NCT03858894    
Other Study ID Numbers: 011712IN
First Posted: March 1, 2019    Key Record Dates
Results First Posted: August 4, 2020
Last Update Posted: August 4, 2020
Last Verified: July 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Glaucoma
Glaucoma, Open-Angle
Ocular Hypertension
Hypertension
Vascular Diseases
 Cardiovascular Diseases
Eye Diseases
Pharmaceutical Solutions
Ophthalmic Solutions