A Phase III Study Assessing the Efficacy and Safety of DE-117 Ophthalmic Solution Compared With Timolol Maleate Ophthalmic Solution 0.5% in Subjects With Glaucoma or Ocular Hypertension - Spectrum 4 Study

Sponsor:

Collaborators:

Information provided by (Responsible Party):

，

Tracking Information

First Submitted Date ^ICMJE

September 28, 2018

First Posted Date ^ICMJE

October 2, 2018

Last Update Posted Date

October 4, 2018

Actual Study Start Date ^ICMJE

September 13, 2018

Estimated Primary Completion Date

June 3, 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Intraocular pressure[ Time Frame: Week 1, Week 6 and Month 3 ]

Change in IOP

Original Primary Outcome Measures ^ICMJE

Same as current

Current Secondary Outcome Measures ^ICMJE

Intraocular pressure[ Time Frame: Week 1, Month 3 ]
Decrease in mean diurnal IOP reduction

Descriptive Information

Brief Title ^ICMJE

A Phase III Study Assessing the Efficacy and Safety of DE-117 Ophthalmic Solution Compared With Timolol Maleate Ophthalmic Solution 0.5% in Subjects With Glaucoma or Ocular Hypertension - Spectrum 4 Study

Official Title ^ICMJE

A Phase III, Randomized, Double-Masked, Active-Controlled, Parallel-Group, Multicenter Study Assessing the Efficacy and Safety of DE-117 Ophthalmic Solution Compared With Timolol Maleate Ophthalmic Solution 0.5% in Subjects With Glaucoma or Ocular Hypertension - Spectrum 4 Study

Brief Summary

This is a Phase III, randomized, double-masked, active-controlled, parallel-group, multi-center study. Subjects diagnosed with glaucoma or OHT who meet eligibility criteria at Visit 1 (Screening) will washout of 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 baseline will be randomized to receive double-masked treatment for 3 months. Approximately 400 adult subjects and up to 30 pediatric subjects with glaucoma or OHT who meet all eligibility criteria will be randomized in a 1:1 ratio to receive either: - DE-117 Ophthalmic Solution once daily and Vehicle once daily, or - Timolol Maleate Ophthalmic Solution 0.5% twice daily. The study will evaluate the efficacy and safety of DE-117 Ophthalmic Solution compared with Timolol Maleate Ophthalmic Solution 0.5% in subjects with glaucoma or OHT through Month 3.

Detailed Description

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Masking: Interventional
Masking Description:
Primary Purpose: Treatment

Condition ^ICMJE

Intervention ^ICMJE

Drug: DE-117 Ophthalmic Solution
Topical DE-117 Ophthalmic Solution once daily and Vehicle once daily for 3 months
Drug: Timolol Maleate Ophthalmic Solution 0.5%
Topical Timolol Maleate Ophthalmic Solution 0.5% twice daily and Vehicle once daily for 3 months

Study Arms

Experimental: DE-117 Ophthalmic Solution
Topical DE-117 Ophthalmic Solution once daily and Vehicle once daily for 3 months
Active Comparator: Timolol Maleate Ophthalmic Solution 0.5%
Topical Timolol Maleate Ophthalmic Solution 0.5% twice daily and Vehicle once daily for 3 months

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

430

Original Estimated Enrollment ^ICMJE

Same as current

Estimated Study Completion Date

October 17, 2019

Estimated Primary Completion Date

June 3, 2019 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria: • glaucoma or ocular hypertension Exclusion Criteria: - Females who are pregnant, nursing, or planning a pregnancy - Any corneal abnormality or other condition interfering with or preventing reliable tonometric measurements

Sex/Gender

Sexes Eligible for Study:

All

Ages

12 Months 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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