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DE-117 Ophthalmic Solution for Glaucoma

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

Study 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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Intraocular Pressure (IOP) at Month 3
Intraocular Pressure (IOP) at Week 1
Intraocular Pressure (IOP) at Week 6
Secondary outcome measures
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
4%
Vision blurred
3%
Conjunctival hyperaemia
2%
Vital dye staining cornea present
2%
Cystoid macular oedema
2%
Eye pain
2%
Vitreous floaters
2%
Punctate keratitis
2%
Macular oedema
1%
Urinary tract infection
1%
Photophobia
1%
Eye irritation
1%
Hypertension
1%
Conjunctival haemorrhage
1%
Cystoid macular
1%
Growth of eyelashes
1%
Eyelash changes
1%
Eyelash thickening
1%
Sinusitis
1%
Upper respiratory tract infection
1%
Eyelash hyperpigmentation
1%
Pneumonia
100%
80%
60%
40%
20%
0%
Study treatment Arm
DE-117 Ophthalmic Solution (Open Label Treatment Period)
DE-117 Ophthalmic Solution (Double Masked Treatment Period)
Timolol Maleate Ophthalmic Solution 0.5% (Double Masked Treatment Period)

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

Frequently Asked Questions

~64 spots leftby Mar 2025