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 3 Study

Overview

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. Adult subjects will receive open-label DE-117 Ophthalmic Solution for an additional 9 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 and will provide additional safety data through Month 12 for subjects receiving DE-117.

Full Title of Study: “A Phase III, Randomized, Double-Masked, Active-Controlled, Parallel-Group, Multi-center 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 3 Study”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: December 6, 2019

Interventions

  • Drug: DE-117 Ophthalmic Solution
    • Topical DE-117 Ophthalmic Solution once daily and Vehicle once daily for 3 months for all subjects, followed by DE-117 Ophthalmic Solution once daily for additional 9 month for adult subjects only
  • Drug: Timolol Maleate Ophthalmic Solution 0.5%
    • Topical Timolol Maleate Ophthalmic Solution 0.5% twice daily for 3 months for all subjects, followed by DE-117 Ophthalmic Solution once daily for additional 9 month for adult subjects only

Arms, Groups and Cohorts

  • Experimental: DE-117 Ophthalmic Solution
    • Topical DE-117 Ophthalmic Solution once daily and Vehicle once daily for 3 months for all subjects, followed by DE-117 Ophthalmic Solution once daily for additional 9 month for adult subjects only
  • Active Comparator: Timolol Maleate Ophthalmic Solution 0.5%
    • Topical Timolol Maleate Ophthalmic Solution 0.5% twice daily for 3 months for all subjects, followed by DE-117 Ophthalmic Solution once daily for additional 9 month for adult subjects only

Clinical Trial Outcome Measures

Primary Measures

  • Intraocular Pressure at Week 1
    • Time Frame: 08:00, 10:00 and 16:00 at Week 1
    • Intraocular Pressure (IOP), the fluid pressure inside the eye was measured with calibrated Goldmann applanation tonometer in millimeters mercury (mmHg) at 3 time points throughout the day. Analysis using Mixed-Effects Model for Repeated Measures (MMRM)
  • Intraocular Pressure at Week 6
    • Time Frame: 08:00, 10:00 and 16:00 at Week 6
    • Intraocular Pressure (IOP), the fluid pressure inside the eye was measured with calibrated Goldmann applanation tonometer in millimeters mercury (mmHg) at 3 time points throughout the day. Analysis using Mixed-Effects Model for Repeated Measures (MMRM)
  • Intraocular Pressure at Month 3
    • Time Frame: 08:00, 10:00 and 16:00 at Month 3
    • Intraocular Pressure (IOP), the fluid pressure inside the eye was measured with calibrated Goldmann applanation tonometer in millimeters mercury (mmHg) at 3 time points throughout the day. Analysis using Mixed-Effects Model for Repeated Measures (MMRM)

Secondary Measures

  • Mean Diurnal Intraocular Pressure (IOP) at Month 3 (First Key Secondary Endpoint)
    • Time Frame: Month 3
    • Mean Diurnal Intraocular Pressure (IOP) at Month 3: Analysis using Mixed-Effects Model for Repeated Measures (MMRM) on observed cases.
  • Intraocular Pressure (IOP) at Week 1 With Baseline Mean Diurnal IOP Less Than 25 mmHg (Second Key Secondary Endpoint)
    • Time Frame: 08:00, 10:00 and 16:00 at Week 1
    • Intraocular Pressure (IOP) at Week 1 with baseline mean diurnal IOP less than 25 mmHg (Second Key Secondary Endpoint)
  • Intraocular Pressure (IOP) at Week 6 With Baseline Mean Diurnal IOP Less Than 25 mmHg (Second Key Secondary Endpoint)
    • Time Frame: 08:00, 10:00 and 16:00 at Week 6
    • Intraocular Pressure (IOP) at Week 6 with baseline mean diurnal IOP less than 25 mmHg (Second Key Secondary Endpoint)
  • Intraocular Pressure (IOP) at Month 3 With Baseline Mean Diurnal IOP Less Than 25 mmHg (Second Key Secondary Endpoint)
    • Time Frame: 08:00, 10:00 and 16:00 at Month 3
    • Intraocular Pressure (IOP) at Month 3 with baseline mean diurnal IOP less than 25 mmHg (Second Key Secondary Endpoint)
  • Mean Diurnal Intraocular Pressure (IOP) at Week 1 (Third Key Secondary Endpoint)
    • Time Frame: Week 1
    • Mean Diurnal Intraocular Pressure (IOP) at Week 1: Analysis using Mixed-Effects Model for Repeated Measures (MMRM) on observed cases. Mean Diurnal IOP at week 1 is defined as the average IOP of all three timepoints (8AM, 10AM and 4PM) at week 1.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 12 Months

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Santen Inc.
  • Provider of Information About this Clinical Study
    • Sponsor

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