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

A Randomized, Double-masked, Placebo- and Active- Controlled, Parallel-group, Multi-center, Dose-response Trial of DE-104 Ophthalmic Solution in Subjects With Primary Open-angle Glaucoma or Ocular Hypertension

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00650338
Enrollment
165
Registered
2008-04-01
Start date
2008-03-31
Completion date
2008-10-31
Last updated
2011-11-03

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

Conditions

Ocular Hypertension, Open-Angle Glaucoma

Brief 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

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

Sponsors

Santen Inc.
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

* 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.

Design outcomes

Primary

MeasureTime frame
To investigate the dose-response relationship of DE-104 in lowering intraocular pressure (IOP)28 days

Secondary

MeasureTime frame
To compare the safety and efficacy of DE-104 ophthalmic solution with placebo and 0.005% latanoprost.35 days

Countries

United States

Outcome results

None listed

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