Summary

for people ages 12 months and up (full criteria)
at UCSF
study started
estimated completion:

Description

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.

Official Title

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

Keywords

Glaucoma and Ocular Hypertension Hypertension Glaucoma Ocular Hypertension Pharmaceutical Solutions Ophthalmic Solutions Timolol Maleic acid DE-117 Ophthalmic Solution Timolol Maleate Ophthalmic Solution 0.5%

Eligibility

You can join if…

Open to people ages 12 months and up

• glaucoma or ocular hypertension

You CAN'T join if...

  • Females who are pregnant, nursing, or planning a pregnancy
  • Any corneal abnormality or other condition interfering with or preventing reliable tonometric measurements

Locations

  • University of California San Francisco not yet accepting patients
    San Francisco California 94143 United States
  • AdvanceMed Clinical Research not yet accepting patients
    San Diego California 92122 United States
  • Eye Research Foundation not yet accepting patients
    Newport Beach California 92663-3642 United States
  • United Medical Research Inst not yet accepting patients
    Inglewood California 90301 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Santen Inc.
ID
NCT03691662
Phase
Phase 3
Study Type
Interventional
Last Updated