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CompletedNCT00650338Updated Nov 3, 2011

Safety and Efficacy Study of DE-104 Ophthalmic Solution to Treat Open-angle Glaucoma or Ocular Hypertension

A Phase 2 interventional study of DE-104 ophthalmic solution, low concentration and DE-104 ophthalmic solution, medium concentration in Open-Angle Glaucoma and Ocular Hypertension, sponsored by Santen Inc.. Completed at 14 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2011-11-03.

Sponsored by Santen Inc. · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
165
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

To investigate the dose-response relationship of DE-104 ophthalmic solution in lowering intraocular pressure (IOP) in subjects with Primary Open-Angle Glaucoma or Ocular Hypertension

02

Conditions studied

  • Open-Angle Glaucoma
  • Ocular Hypertension
03

In context

Glaucoma

1,818 studies on the registry are indexed under Glaucoma; 231 are open to participants now.

This study's planned enrollment of 165 is above the median of 65 across 1,272 interventional studies indexed under Glaucoma.

Browse Glaucoma studies →

Lead sponsor

Santen Inc. is the lead sponsor of 31 studies on the registry; none are open to participants now.

Of its 10 completed or terminated interventional studies of FDA-regulated products, 10 (100%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Provided signed, written informed consent.
  • Diagnosed with primary open-angle glaucoma or ocular hypertension.
  • 18 years of age and older.
  • If a subject is a female of childbearing potential, she must utilize reliable contraceptive throughout the study, and must have a negative urine pregnancy test prior to enrollment into this study.

Exclusion criteria

Exclusion Criteria:

  • Females who are pregnant, nursing or planning a pregnancy, or females of childbearing potential who are not using a reliable method of contraception.
  • Presence of any abnormality or significant illness that could be expected to interfere with the study.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
165 participants (estimated)

Study arms

  • Experimental
    1

    \<described in intervention\>

    Drug: DE-104 ophthalmic solution, low concentration

  • Experimental
    2

    \<described in intervention\>

    Drug: DE-104 ophthalmic solution, medium concentration

  • Experimental
    3

    \<described in intervention\>

    Drug: DE-104 ophthalmic solution, high concentration

  • Placebo comparator
    4

    \<described in intervention\>

    Drug: Placebo

  • Active comparator
    5

    \<described intervention\>

    Drug: 0.005% latanoprost

Interventions

  • DrugDE-104 ophthalmic solution, low concentration

    Topical ocular application

  • DrugDE-104 ophthalmic solution, medium concentration

    Topical ocular application

  • DrugDE-104 ophthalmic solution, high concentration

    Topical ocular application

  • DrugPlacebo

    placebo

  • Drug0.005% latanoprost

    Topical ocular application

06

What researchers measure

Primary outcomes

  1. To investigate the dose-response relationship of DE-104 in lowering intraocular pressure (IOP)

    Time frame: 28 days

Secondary outcomes

  1. To compare the safety and efficacy of DE-104 ophthalmic solution with placebo and 0.005% latanoprost.

    Time frame: 35 days

07

Study locations

14 sites
  • Sall Research Medical Center
    Artesia, California 90701, United States
  • USC Department of Ophthalmology
    Los Angeles, California 90033, United States
  • Wolstan Eye Associates
    Torrance, California 90505, United States
  • East Florida Eye Institute
    Stuart, Florida 34994, United States
  • Seidenberg Protzko Eye Associates
    Bel Air, Maryland 21014, United States
  • University of Nebraska Medical Center
    Omaha, Nebraska 68198-5540, United States
  • Rochester Ophthalmological Group, PC
    Rochester, New York 14618, United States
  • Cornerstone Eye Care
    High Point, North Carolina 27262, United States
  • Associated Glaucoma Consultants
    Philadelphia, Pennsylvania 19107, United States
  • Keystone Research, Ltd.
    Austin, Texas 78731, United States
  • David Shulman, MD P-A
    San Antonio, Texas 78209, United States
  • Eye Clinics of South Texas
    San Antonio, Texas 78209, United States
  • Medical Center Ophthalmology Associates
    San Antonio, Texas 78240, United States
  • Virginia Eye Consultants
    Norfolk, Virginia 23507, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 3, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00650338
Lead sponsor
Santen Inc.
Responsible party
Sponsor
First posted
Apr 1, 2008
Start date
Mar 2008
Primary completion
Sep 2008
Completion
Oct 2008
Last update
Nov 3, 2011
View the source record on ClinicalTrials.gov ↗

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