Open-Angle GlaucomaPhase 2NCT00657579

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

A Phase 2 study testing DE-104 ophthalmic solution, low concentration, DE-104 ophthalmic solution, medium concentration and DE-104 ophthalmic solution, high concentration in people with Open-Angle Glaucoma and Ocular Hypertension, run by Santen Pharmaceutical Co., Ltd. at 1 site in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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 Read more about this study

Who is it for?: Ages 20 to 74 years
Conditions the study is for: Open-Angle Glaucoma, Ocular Hypertension
What is being tested?: DE-104 ophthalmic solution, low concentration, DE-104 ophthalmic solution, medium concentration and DE-104 ophthalmic solution, high concentration
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: Not given
Where: 1 siteJapan
Study dates: Start not givento not given
Phase: Phase 2
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 20 to 74 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Diagnosed with primary open-angle glaucoma or ocular hypertension.
Provided signed, written informed consent.
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.

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

Japan1 site

Osaka, Japan
Osaka

Other trials in Japan

About this study

Official title: A Randomized, Double-Masked, Parallel-Group, Dose-Response Trial of DE-104 Ophthalmic Solution in Subjects With Open-Angle Glaucoma or Ocular Hypertension

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

Conditions: Open-Angle Glaucoma, Ocular Hypertension
Being tested: DE-104 ophthalmic solution, low concentration, DE-104 ophthalmic solution, medium concentration, DE-104 ophthalmic solution, high concentration, DE-104 vehicle
Medical subject headings: Glaucoma, Open-Angle, Ocular Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

DE-104 ophthalmic solution, low concentrationDrug
DE-104 ophthalmic solution, medium concentrationDrug
DE-104 ophthalmic solution, high concentrationDrug
DE-104 vehicleDrug

Study groups in NCT00657579
Study group	Role	What they receive
1	Experimental	Not described Receives: Drug: DE-104 ophthalmic solution, low concentration
2	Experimental	Not described Receives: Drug: DE-104 ophthalmic solution, medium concentration
3	Experimental	Not described Receives: Drug: DE-104 ophthalmic solution, high concentration
4	Placebo comparator	Not described Receives: Drug: DE-104 vehicle

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

First posted14 Apr 2008 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Open-Angle GlaucomaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2

IDs, dates and publications

ClinicalTrials.gov ID: NCT00657579
Sponsor's protocol ID: 01040702
Status last verified: Mar 2009
First submitted: 7 Apr 2008
Last updated: 16 Mar 2009
Results posted: No
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 2
A Phase 2a Study Comparing the Efficacy, Safety and Tolerability of Pregabalin Eye Drops Comparing With Timolol Eye Drops in Adults With Glaucoma or High Eye Pressure.
Primary Open - Angle Glaucoma (POAG), Ocular Hypertension (OHT)
Recruiting
The Acute Effect of Exercise Type And Timing on Ambulatory Blood Pressure and Intra-Ocular Pressure in Individuals With Glaucoma (The ACHIEVE-project).
Glaucoma Open-Angle Primary, Hypertension
RecruitingPhase 4
Adaptive Optics OCT Evaluation of Rhopressa's Effects on the Retinal Ganglion Cells in Glaucoma Patients
Open Angle Glaucoma (OAG), Glaucoma
RecruitingObservational study
PRESERFLO™ MicroShunt XI Observational PMCF Study With no Control Group
Primary Open Angle Glaucoma
Active, not recruitingObservational study
Glaucoma, Visual Field Loss, and Their Association With Life Space in Older Adults
Primary Open Angle Glaucoma

All Open-Angle Glaucoma trials

Study at a glance

From the registry record, last updated by the sponsor on 16 Mar 2009. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Double-Masked, Parallel-Group, Dose-Response Trial of DE-104 Ophthalmic Solution in Subjects With Open-Angle Glaucoma or Ocular Hypertension
ClinicalTrials.gov ID: NCT00657579
Acronym / sponsor ID: 01040702
Conditions: Open-Angle Glaucoma, Ocular Hypertension
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Lead sponsor: Santen Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
First posted: 14 Apr 2008 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Number of arms: 4

Arm	Type	Receives
1	Experimental	Drug: DE-104 ophthalmic solution, low concentration
2	Experimental	Drug: DE-104 ophthalmic solution, medium concentration
3	Experimental	Drug: DE-104 ophthalmic solution, high concentration
4	Placebo comparator	Drug: DE-104 vehicle

Who may qualify

Ages: 20 to 74 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Diagnosed with primary open-angle glaucoma or ocular hypertension.
Provided signed, written informed consent.
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.

Key exclusion criteria (2 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
DE-104 ophthalmic solution, low concentration	Drug	1
DE-104 ophthalmic solution, medium concentration	Drug	2
DE-104 ophthalmic solution, high concentration	Drug	3
DE-104 vehicle	Drug	4

Primary outcome

Not reported in the source record.

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2009.

Related trials for Open-Angle Glaucoma

RecruitingPhase 2
A Phase 2a Study Comparing the Efficacy, Safety and Tolerability of Pregabalin Eye Drops Comparing With Timolol Eye Drops in Adults With Glaucoma or High Eye Pressure.
Primary Open - Angle Glaucoma (POAG), Ocular Hypertension (OHT)
Recruiting
The Acute Effect of Exercise Type And Timing on Ambulatory Blood Pressure and Intra-Ocular Pressure in Individuals With Glaucoma (The ACHIEVE-project).
Glaucoma Open-Angle Primary, Hypertension
RecruitingPhase 4
Adaptive Optics OCT Evaluation of Rhopressa's Effects on the Retinal Ganglion Cells in Glaucoma Patients
Open Angle Glaucoma (OAG), Glaucoma
RecruitingObservational study
PRESERFLO™ MicroShunt XI Observational PMCF Study With no Control Group
Primary Open Angle Glaucoma
Active, not recruitingObservational study
Glaucoma, Visual Field Loss, and Their Association With Life Space in Older Adults
Primary Open Angle Glaucoma

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Mar 2009. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00657579.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2009.