NCT01654484

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jul 2012

Shorter than P25 for phase_1

Geographic Reach
1 country

10 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2012

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

July 27, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 31, 2012

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2012

Completed
Last Updated

April 18, 2018

Status Verified

April 1, 2018

Enrollment Period

4 months

First QC Date

July 27, 2012

Last Update Submit

April 16, 2018

Conditions

Glaucoma and Ocular Hypertension

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (8)

Low Dose DE-117

EXPERIMENTAL

Monotherapy

Drug: DE-117

Medium Dose DE-117

EXPERIMENTAL

Monotherapy

Drug: DE-117

High Dose DE-117

EXPERIMENTAL

Monotherapy

Drug: DE-117

Low Dose DE-117 and 0.0015% tafluprost

EXPERIMENTAL

Adjunctive Therapy

Drug: DE-117 and 0.0015% tafluprost

Med. Dose DE-117 and 0.0015% tafluprost

EXPERIMENTAL

Adjunctive Therapy

Drug: DE-117 and 0.0015% tafluprost

High Dose DE-117 and 0.0015% tafluprost

EXPERIMENTAL

Adjunctive Therapy

Drug: DE-117 and 0.0015% tafluprost

0.0015% tafluprost

ACTIVE COMPARATOR

Monotherapy

Drug: 0.0015% tafluprost

Placebo

PLACEBO COMPARATOR

Monotherapy

Drug: Placebo

Interventions

DE-117DRUG

Ophthalmic Solution, QD, 28 Days

High Dose DE-117Low Dose DE-117Medium Dose DE-117
0.0015% tafluprostDRUG

Ophthalmic Solution, QD, 28 days

0.0015% tafluprost
DE-117 and 0.0015% tafluprostDRUG

Ophthalmic Solutions, QD, 28 days

High Dose DE-117 and 0.0015% tafluprostLow Dose DE-117 and 0.0015% tafluprostMed. Dose DE-117 and 0.0015% tafluprost
PlaceboDRUG

Ophthalmic Solution, QD, 28 days

Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Santen Investigational Site

Newport Beach, California, 92663, United States

Location

Santen Investigational Site

Deerfield Beach, Florida, 33064, United States

Location

Santen Investigational Site

Largo, Florida, 33773, United States

Location

Santen Investigational Site

Morrow, Georgia, 30260, United States

Location

Santen Investigational Site

Roswell, Georgia, 30076, United States

Location

Santen Investigational Site

Rochester, New York, 14618, United States

Location

Santen Investigational Site

Cleveland, Ohio, 44115, United States

Location

Santen Investigational Site

Austin, Texas, 78731, United States

Location

Santen Investigational Site

Fort Worth, Texas, 76102, United States

Location

Santen Investigational Site

San Antonio, Texas, 78240, United States

Location

MeSH Terms

Conditions

GlaucomaOcular Hypertension

Interventions

tafluprost

Condition Hierarchy (Ancestors)

Eye Diseases

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 27, 2012

First Posted

July 31, 2012

Study Start

July 1, 2012

Primary Completion

November 1, 2012

Study Completion

November 1, 2012

Last Updated

April 18, 2018

Record last verified: 2018-04

Locations

US(10)