Open Angle GlaucomaPhase 3NCT01342094

DE-111 Against Timolol Ophthalmic Solution 0.5%

A Phase 3 study testing DE-111 ophthalmic solution and Timolol ophthalmic solution 0.5% 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

DE-111 ophthalmic solution will be evaluated for superiority in comparison with Timolol ophthalmic solution 0.5%, in IOP(intraocular pressure ) -lowering effect in primary open-angle glaucoma or ocular hypertension patients, in a multicenter, randomized, double-masked, parallel-group comparison study. Read more about this study

Who is it for?: Ages 20 years and older
Conditions the study is for: Open Angle Glaucoma, Ocular Hypertension
What is being tested?: DE-111 ophthalmic solution and Timolol ophthalmic solution 0.5%
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 166 participants
Where: 1 siteJapan
Study dates: May 2011to Sep 2012
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 years and older
All sexes
Adult, Older adult

Who may be able to join

Diagnosed with primary open angle glaucoma or ocular hypertension
Provided signed, written informed consent
20 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

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

Santen study sites
Osaka, Osaka

Other trials in Japan

About this study

Official title: A Double-masked Study of DE-111 Ophthalmic Solution Versus Timolol Ophthalmic Solution 0.5% in Patients With Primary Open Angle Glaucoma or Ocular Hypertension - Phase 3, Confirmatory Study -

Conditions: Open Angle Glaucoma, Ocular Hypertension
Being tested: DE-111 ophthalmic solution, Timolol ophthalmic solution 0.5%, Placebo ophthalmic solution
Keywords: Primary open angle glaucoma or ocular hypertension
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-111 ophthalmic solutionDrug
Timolol ophthalmic solution 0.5%Drug
Placebo ophthalmic solutionDrug

Study groups in NCT01342094
Study group	Role	What they receive
DE-111 ophthalmic solution	Experimental	DE-111 ophthalmic solution (one drop at a time, once daily) and Placebo ophthalmic solution (one drop at a time, BID) in both eyes. Receives: Drug: DE-111 ophthalmic solution; Drug: Placebo ophthalmic solution
Timolol ophthalmic solution 0.5%	Active comparator	Timolol ophthalmic solution 0.5% (one drop at a time, BID) and Placebo ophthalmic solution (one drop at a time, once daily) in both eyes. Receives: Drug: Timolol ophthalmic solution 0.5%; Drug: Placebo ophthalmic solution

What is being measured

The primary outcome is the main question the study is designed to answer.

Change From Baseline in Mean Diurnal IOP (Intraocular Pressure) at End of Study
Mean diurnal IOP (intraocular pressure) was calculated as an average of IOP (intraocular pressure) at 9:30 (pre-dose), 11:30 and 17:30.
Measured: Week 0(Baseline) and Week 4(End of Study)

Timeline

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

May 2011Sep 2012

First posted26 Apr 2011 (estimated)
Study startMay 2011
Primary completionSep 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
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 3
Primary purpose: Treatment
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 166 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01342094
Sponsor's protocol ID: 01111005
Status last verified: Jun 2015
First submitted: 24 Apr 2011
Last updated: 10 Jul 2015
Results posted: Yes, on ClinicalTrials.gov

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

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All Open Angle Glaucoma trials

Study at a glance

From the registry record, last updated by the sponsor on 10 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Double-masked Study of DE-111 Ophthalmic Solution Versus Timolol Ophthalmic Solution 0.5% in Patients With Primary Open Angle Glaucoma or Ocular Hypertension - Phase 3, Confirmatory Study -
ClinicalTrials.gov ID: NCT01342094
Acronym / sponsor ID: 01111005
Conditions: Open Angle Glaucoma, Ocular Hypertension
Keywords: Primary open angle glaucoma or ocular hypertension
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 166 participants (actual)
Lead sponsor: Santen Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
Study start: May 2011
Primary completion: Sep 2012 (actual)
First posted: 26 Apr 2011 (estimated)
Results: Posted 15 May 2015

Clinical summary

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

Study design

Primary purpose: Treatment
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
DE-111 ophthalmic solution	Experimental	Drug: DE-111 ophthalmic solution, Drug: Placebo ophthalmic solutionDE-111 ophthalmic solution (one drop at a time, once daily) and Placebo ophthalmic solution (one drop at a time, BID) in both eyes.
Timolol ophthalmic solution 0.5%	Active comparator	Drug: Timolol ophthalmic solution 0.5%, Drug: Placebo ophthalmic solutionTimolol ophthalmic solution 0.5% (one drop at a time, BID) and Placebo ophthalmic solution (one drop at a time, once daily) in both eyes.

Who may qualify

Ages: 20 years and older
Sex: All
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Diagnosed with primary open angle glaucoma or ocular hypertension
Provided signed, written informed consent
20 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

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-111 ophthalmic solution	Drug	DE-111 ophthalmic solution
Timolol ophthalmic solution 0.5%	Drug	Timolol ophthalmic solution 0.5%
Placebo ophthalmic solution	Drug	DE-111 ophthalmic solution, Timolol ophthalmic solution 0.5%

Primary outcome

Change From Baseline in Mean Diurnal IOP (Intraocular Pressure) at End of Study
Time frame: Week 0(Baseline) and Week 4(End of Study)
Mean diurnal IOP (intraocular pressure) was calculated as an average of IOP (intraocular pressure) at 9:30 (pre-dose), 11:30 and 17:30.

Results and safety

Results posted to the registry on 15 May 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
DE-111	82	77
Timolol	84	81

Primary outcome: Change From Baseline in Mean Diurnal IOP (Intraocular Pressure) at End of Study

Time frame: Week 0(Baseline) and Week 4(End of Study). Mean (Standard Deviation). Unit: mmHg

Measure	DE-111 n = 82	Timolol n = 84
Value	-3.2 (2.1)	-1.7 (2.1)

DE-111 vs Timolol: Mean Difference (Final Values): -1.5 (95% CI -2.2 to -0.9), p < 0.001, ANCOVA

Adverse events

Time frame: Week 0(Baseline) and Week 4(End of Study). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
DE-111	0 of 82 (0%)	11 of 82 (13.4%)	Not reported
Timolol	0 of 84 (0%)	2 of 84 (2.4%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Open Angle Glaucoma

Recruiting
A Study Evaluating the Safety and Efficacy of MINIject S+ in Subjects With Open Angle Glaucoma
Glaucoma
Active, not recruiting
OMNI 3.1 Surgical System in Subjects With Primary Open-Angle Glaucoma
Primary Open Angle Glaucoma
Not yet recruiting
Evaluation the Safety and Effectiveness of the GORE GDI in Adult Subjects With Primary Open-angle Glaucoma in Whom Previous Medical and Surgical Treatment Have Failed.
Glaucoma, Primary Open Angle
Active, not recruiting
Electrical Stimulation for the Treatment of Optic Neuropathies
Glaucoma, Glaucoma, Open-Angle
Not yet recruitingPhase 4
The Effect of Lumify™ on Ocular Redness, Intraocular Pressure, and Eyelid Position in Glaucoma Patients
Glaucoma, Glaucoma, Open-Angle

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 4 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 10 Jul 2015. 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. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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

Are results available for this study?

Yes. Results are posted in the registry (first posted 15 May 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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.

What does the primary outcome measure?

Change From Baseline in Mean Diurnal IOP (Intraocular Pressure) at End of Study (time frame: Week 0(Baseline) and Week 4(End of Study)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01342094.

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 10 Jul 2015.