DE-117 Spectrum 5 Study

Sponsor:

Collaborators:

Information provided by (Responsible Party):

，

Tracking Information

First Submitted Date ^ICMJE

October 3, 2018

First Posted Date ^ICMJE

October 5, 2018

Last Update Posted Date

October 5, 2018

Actual Study Start Date ^ICMJE

September 27, 2018

Estimated Primary Completion Date

October 31, 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Intraocular pressure[ Time Frame: Month 3 ]

Reduction in IOP in Latanoprost low/non-responder subjects

Original Primary Outcome Measures ^ICMJE

Same as current

Current Secondary Outcome Measures ^ICMJE

[ Time Frame: ]

Descriptive Information

Brief Title ^ICMJE

DE-117 Spectrum 5 Study

Official Title ^ICMJE

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

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

Detailed Description

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation:
Intervention Model: Single Group Assignment
Intervention Model Description:
Masking: Interventional
Masking Description:
Primary Purpose: Treatment

Condition ^ICMJE

Intervention ^ICMJE

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.

Study Arms

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.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

150

Original Estimated Enrollment ^ICMJE

Same as current

Estimated Study Completion Date

November 30, 2019

Estimated Primary Completion Date

October 31, 2019 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Sex/Gender

Sexes Eligible for Study:

All

Ages

18 Years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Listed Location Countries ^ICMJE

United States

Removed Location Countries

Administrative Information

Has Data Monitoring Committee

U.S. FDA-regulated Product

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

Plan to Share IPD:

Responsible Party

，

Study Sponsor ^ICMJE

Santen Inc.

Collaborators ^ICMJE

Investigators ^ICMJE

PRS Account

Verification Date

October 2018

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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