A Study Assessing the Safety and Efficacy of DE-117 Ophthalmic Solution in Patients With POAG or OHT

A Phase I/II, Randomized, Observer-masked, Placebo-and Active-controlled, Parallel-group, Multi-center Study Assessing the Safety and Efficacy of DE-117 Ophthalmic Solution in Subjects With Primary Open-angle Glaucoma or Ocular Hypertension

Status

Completed

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01654484

Enrollment

Registered

2012-07-31

Start date

2012-07-31

Completion date

2012-11-30

Last updated

2018-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Glaucoma and Ocular Hypertension

Brief summary

The purpose of this study is to investigate the safety and efficacy of up to three concentrations of DE-117 ophthalmic solution (Low Dose, Medium Dose, and High Dose) as monotherapy and as adjunctive therapy (DE-117 ophthalmic solution with 0.0015% tafluprost) in subjects with primary open-angle glaucoma or ocular hypertension.

Detailed description

This is a two stage study. Stage One will explore the dose response of three concentrations of DE-117 as monotherapy compared with 0.0015% tafluprost and placebo. The safety and efficacy of DE-117 as adjunctive therapy (with 0.0015% tafluprost) compared with 0.0015% tafluprost and placebo will also be evaluated. In addition, the additive effect of adjunctive therapy of each concentration will be compared with the corresponding monotherapy concentration. Stage Two will assess the safety and efficacy of the optimal DE-117 concentration as monotherapy compared with 0.0015% tafluprost. The safety and efficacy of the optimal DE-117 concentration as adjunctive therapy (with 0.0015% tafluprost) compared with DE-117 monotherapy and 0.0015% tafluprost will also be evaluated.

Interventions

DRUGDE-117

Ophthalmic Solution, QD, 28 Days

DRUG0.0015% tafluprost

Ophthalmic Solution, QD, 28 days

DRUGDE-117 and 0.0015% tafluprost

Ophthalmic Solutions, QD, 28 days

DRUGPlacebo

Ophthalmic Solution, QD, 28 days

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

1. Male or Female, 18 years of age or older 2. Current diagnosis of primary open-angle glaucoma or ocular hypertension in both eyes 3. Qualifying intraocular pressure (IOP) in at least one eye at Baseline

Exclusion criteria

1. Closed/barely open anterior chamber angle or a history of acute angle closure in either eye 2. Anticipate the need to initiate or modify medication (systemic or topical) that is known to affect intraocular pressure (IOP) during the study period 3. Females who are pregnant, nursing or planning a pregnancy 4. Presence of any abnormality or significant illness that could be expected to interfere with the study.

Design outcomes

Primary

Measure	Time frame
Change from baseline in intraocular pressure (IOP) on Day 29 at each scheduled time point	Day 28 T0 (08:00 ±30 mins), T0+2 hrs, T0+4 hrs, T0+8 hrs

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026