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DE-117 Spectrum 5 Study

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: NCT03697811
Recruitment Status : Unknown
Verified January 2020 by Santen Inc..
Recruitment status was:  Recruiting
First Posted : October 5, 2018
Last Update Posted : January 10, 2020
Sponsor:
Information provided by (Responsible Party):
Santen Inc.

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

Condition or disease Intervention/treatment Phase
Primary Open-angle Glaucoma and Ocular Hypertension Drug: DE-117 Ophthalmic Solution Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : September 27, 2018
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma

Arms and Interventions
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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.
 Drug: DE-117 Ophthalmic Solution
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.


Outcome Measures
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Primary Outcome Measures :
  1. Intraocular pressure [ Time Frame: Month 3 ]
    Change in IOP in Latanoprost low/non-responder subjects


Eligibility Criteria
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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:

  • 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.

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.
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): NCT03697811


Contacts
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Contact: Santen Inc Clinical Operations 415-268-9052 clinicaltrials@santen.com

Locations
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Sponsors and Collaborators
Santen Inc.
More Information
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Responsible Party: Santen Inc.
ClinicalTrials.gov Identifier: NCT03697811    
Other Study ID Numbers: 011711IN
First Posted: October 5, 2018    Key Record Dates
Last Update Posted: January 10, 2020
Last Verified: January 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
Ophthalmic Solutions
Pharmaceutical Solutions