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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

Phase 3
Waitlist Available
Research Sponsored by Santen Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
• glaucoma or ocular hypertension
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 08:00, 10:00 and 16:00 at month 3
Awards & highlights
No Placebo-Only Group
Pivotal Trial

Summary

This trial is testing two types of eye drops, DE-117 and Timolol, in adults and children with glaucoma or high eye pressure. Both treatments aim to lower eye pressure but work in different ways.

Eligible Conditions
  • Glaucoma

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~08:00, 10:00 and 16:00 at month 3
This trial's timeline: 3 weeks for screening, Varies for treatment, and 08:00, 10:00 and 16:00 at month 3 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Intraocular Pressure (IOP) at Month 3
Intraocular Pressure (IOP) at Week 1
Intraocular Pressure (IOP) at Week 6
Secondary study objectives
Intraocular Pressure (IOP) at Month 3 With Baseline Mean Diurnal IOP Less Than 25 mmHg (Second Key Secondary Endpoint)
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)
+2 more

Side effects data

From 2020 Phase 3 trial • 426 Patients • NCT03691649
6%
Conjunctival hyperaemia
5%
Vision blurred
5%
Photophobia
3%
Vital dye staining cornea present
3%
Ocular hyperaemia
2%
Instillation site pain
2%
Headache
2%
Eye pain
2%
Visual impairment
2%
Dry eye
1%
Vitreous floaters
1%
Eye irritation
1%
Vitreous detachment
1%
Growth of eyelashes
100%
80%
60%
40%
20%
0%
Study treatment Arm
DE-117 Ophthalmic Solution (Double Masked Treatment Period)
Timolol Maleate Ophthalmic Solution 0.5% (Double Masked Treatment Period)
DE-117 Ophthalmic Solution (Open Label Treatment Period)

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: DE-117 Ophthalmic SolutionExperimental Treatment1 Intervention
Topical DE-117 Ophthalmic Solution once daily and Vehicle once daily for 3 months
Group II: Timolol Maleate Ophthalmic Solution 0.5%Active Control1 Intervention
Topical Timolol Maleate Ophthalmic Solution 0.5% twice daily for 3 months
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Omidenepag isopropyl
Not yet FDA approved

Find a Location

Who is running the clinical trial?

Santen Inc.Lead Sponsor
34 Previous Clinical Trials
4,152 Total Patients Enrolled
11 Trials studying Glaucoma
1,891 Patients Enrolled for Glaucoma
~58 spots leftby Dec 2025
Unbiased ResultsWe believe in providing patients with all the options.
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