Open-angle GlaucomaPhase 2SEE-1NCT02179008

Multi-center Phase II Study Assessing the Safety and Efficacy of DE-117 Ophthalmic Solution in Subjects With Primary Open-angle Glaucoma or Ocular Hypertension

A Phase 2 study testing DE-117 Low Dose ophthalmic solution, DE-117 Low/Middle Dose ophthalmic solution and DE-117 Middle Dose ophthalmic solution in people with Open-angle Glaucoma and Ocular Hypertension, run by Santen Inc. at 14 sites in United States.

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

The purpose of this study is to investigate the safety and efficacy of five concentrations of DE-117 ophthalmic solution. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Open-angle Glaucoma, Ocular Hypertension
What is being tested?: DE-117 Low Dose ophthalmic solution, DE-117 Low/Middle Dose ophthalmic solution and DE-117 Middle Dose ophthalmic solution
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 184 participants
Where: 14 sitesUnited States
Study dates: Jun 2014to Jan 2015
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 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Current diagnosis of primary open-angle glaucoma or ocular hypertension in both eyes
Qualifying intraocular pressure in at least one eye at Baseline
Qualifying corrected ETDRS visual acuity in each eye
Qualifying central cornea thickness in each eye

Who cannot join

Closed/barely open anterior chamber angle or a history of acute angle closure in either eye
Diagnosis of primary open-angle glaucoma or ocular hypertension due to etiology known to be non-responsive to conventional drug therapy
Evidence of advanced glaucoma, visual field defect or progressive visual field loss that that do not meet the study criteria
History of ocular surgery specifically intended to lower IOP
History of any ocular or systemic abnormality or condition that may put the subject at significant risk, may confound study results, or may interfere significantly with the subject's participation in the study
Intended or current use of any ocular medications other than study medications during the study

Show all 11Show fewer

Use of contact lenses within one week prior to Baseline (Day 1) until end of treatment
Known allergy or sensitivity to any components of the study medications
Use of steroids (systemic) within 30 days prior to Visit 1 (Screening)
Anticipate the need to initiate or modify an existing chronic therapy that could substantially affect IOP or the study outcomes during the study period
Females who are pregnant, nursing or planning a pregnancy

Trial locations and contacts

14 sites in 1 country.

City, postcode or hospital

14 sites in 1 country

United States14 sites

Study site
Artesia, California, 90701
Study site
Austin, Texas, 78731
Study site
Chandler, Arizona, 85225
Study site
Cleveland, Ohio, 44115
Study site
Glendale, California, 91204
Study site
High Point, North Carolina, 27262
Study site
Houston, Texas, 77005
Study site
Largo, Florida, 33773
Study site
Long Beach, California, 90806
Study site
Morrow, Georgia, 30260
Study site
Newport Beach, California, 92663
Study site
Rochester, New York, 14618
Study site
Roswell, Georgia, 30076
Study site
San Antonio, Texas, 78240

Other trials in United States

About this study

The purpose of this study is to investigate the safety and efficacy of five concentrations of DE-117 ophthalmic solution.

Read the detailed description

This is a 90-day randomized, observer-masked, active-controlled, parallel-group, multi-center, study assessing the safety and efficacy of five concentrations of DE-117 ophthalmic solution when compared to latanoprost (0.005% latanoprost) in subjects with primary open-angle glaucoma or ocular hypertension.

Conditions: Open-angle Glaucoma, Ocular Hypertension
Being tested: DE-117 Low Dose ophthalmic solution, DE-117 Low/Middle Dose ophthalmic solution, DE-117 Middle Dose ophthalmic solution, DE-117 Middle/High Dose ophthalmic solution, DE-117 High Dose ophthalmic solution
Keywords: Santen, Eye, Glaucoma, Ocular hypertension
Medical subject headings: Glaucoma, Open-Angle, Ocular Hypertension, Glaucoma

What participants receive

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

DE-117 Low Dose ophthalmic solutionDrug
Also called DE-117
Low Dose DE-117 ophthalmic solution
DE-117 Low/Middle Dose ophthalmic solutionDrug
Also called DE-117
Low/Middle Dose DE-117
DE-117 Middle Dose ophthalmic solutionDrug
Also called DE-117
Middle Dose DE-117
DE-117 Middle/High Dose ophthalmic solutionDrug
Also called DE-117
Middle/High Dose DE-117
DE-117 High Dose ophthalmic solutionDrug
Also called DE-117
High Dose DE-117
latanoprost ophthalmic solution 0.005%Drug
Also called latanoprost
0.005% latanoprost

Study groups in NCT02179008
Study group	Role	What they receive
DE-117 Low Dose ophthalmic solution	Experimental	One drop Low Dose DE-117 in each eye QD for 90 days Receives: Drug: DE-117 Low Dose ophthalmic solution
DE-117 Low/Middle Dose ophthalmic solution	Experimental	One drop DE-117 Low/Middle Dose ophthalmic solution in each eye QD for 90 days Receives: Drug: DE-117 Low/Middle Dose ophthalmic solution
DE-117 Middle Dose ophthalmic solution	Experimental	One drop Middle Dose DE-117 in each eye QD for 90 days Receives: Drug: DE-117 Middle Dose ophthalmic solution
DE-117 Middle/High Dose ophthalmic solution	Experimental	One drop Middle/High Dose DE-117 in each eye QD for 90 days Receives: Drug: DE-117 Middle/High Dose ophthalmic solution
DE-117 High Dose ophthalmic solution	Experimental	One drop High Dose DE-117 in each eye QD for 90 days Receives: Drug: DE-117 High Dose ophthalmic solution
latanoprost ophthalmic solution 0.005%	Active comparator	One drop latanaprost in each eye QD for 90 days Receives: Drug: latanoprost ophthalmic solution 0.005%

What is being measured

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

Intraocular pressure (mmHg)
Intraocular pressure (mmHg) measurements will be collected using Goldmann applanation tonometry
Measured: Day 91

Secondary outcomes (1)

Number of Subjects with Adverse Events as a Measure of Safety and Tolerability
Adverse events will be assessed at each visit to evaluate safety
Measured: Day 1, Day 8, Day 15, Day 31, Day 61 and Day 91

Timeline

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

Jun 2014Jan 2015

First posted1 Jul 2014 (estimated)
Study startJun 2014
Primary completionJan 2015
Study completionJan 2015

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
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 184 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02179008
Sponsor's protocol ID: 33-003
Acronym: SEE-1
Status last verified: Apr 2018
First submitted: 26 Jun 2014
Last updated: 18 Apr 2018
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

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
RecruitingObservational study
PRESERFLO™ MicroShunt XI Observational PMCF Study With no Control Group
Primary Open Angle Glaucoma
RecruitingPhase 4
Adaptive Optics OCT Evaluation of Rhopressa's Effects on the Retinal Ganglion Cells in Glaucoma Patients
Open Angle Glaucoma (OAG), Glaucoma
Active, not recruitingObservational study
Impact of Glaucoma and Visual Field Loss on Life Space
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 18 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Multi-center Phase II Study Assessing the Safety and Efficacy of DE-117 Ophthalmic Solution in Subjects With Primary Open-angle Glaucoma or Ocular Hypertension
ClinicalTrials.gov ID: NCT02179008
Acronym / sponsor ID: SEE-1 / 33-003
Conditions: Open-angle Glaucoma, Ocular Hypertension
Keywords: Santen, Eye, Glaucoma, Ocular hypertension
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 184 participants (actual)
Lead sponsor: Santen Inc.Industry (pharma, biotech, devices)
Study start: Jun 2014
Primary completion: Jan 2015 (actual)
Study completion: Jan 2015 (actual)
First posted: 1 Jul 2014 (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.

The purpose of this study is to investigate the safety and efficacy of five concentrations of DE-117 ophthalmic solution.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 6

Arm	Type	Receives
DE-117 Low Dose ophthalmic solution	Experimental	Drug: DE-117 Low Dose ophthalmic solutionOne drop Low Dose DE-117 in each eye QD for 90 days
DE-117 Low/Middle Dose ophthalmic solution	Experimental	Drug: DE-117 Low/Middle Dose ophthalmic solutionOne drop DE-117 Low/Middle Dose ophthalmic solution in each eye QD for 90 days
DE-117 Middle Dose ophthalmic solution	Experimental	Drug: DE-117 Middle Dose ophthalmic solutionOne drop Middle Dose DE-117 in each eye QD for 90 days
DE-117 Middle/High Dose ophthalmic solution	Experimental	Drug: DE-117 Middle/High Dose ophthalmic solutionOne drop Middle/High Dose DE-117 in each eye QD for 90 days
DE-117 High Dose ophthalmic solution	Experimental	Drug: DE-117 High Dose ophthalmic solutionOne drop High Dose DE-117 in each eye QD for 90 days
latanoprost ophthalmic solution 0.005%	Active comparator	Drug: latanoprost ophthalmic solution 0.005%One drop latanaprost in each eye QD for 90 days

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Current diagnosis of primary open-angle glaucoma or ocular hypertension in both eyes
Qualifying intraocular pressure in at least one eye at Baseline
Qualifying corrected ETDRS visual acuity in each eye
Qualifying central cornea thickness in each eye

Key exclusion criteria (11 listed)

Closed/barely open anterior chamber angle or a history of acute angle closure in either eye
Diagnosis of primary open-angle glaucoma or ocular hypertension due to etiology known to be non-responsive to conventional drug therapy
Evidence of advanced glaucoma, visual field defect or progressive visual field loss that that do not meet the study criteria
History of ocular surgery specifically intended to lower IOP
History of any ocular or systemic abnormality or condition that may put the subject at significant risk, may confound study results, or may interfere significantly with the subject's participation in 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-117 Low Dose ophthalmic solutionAlso: DE-117Low Dose DE-117 ophthalmic solution	Drug	DE-117 Low Dose ophthalmic solution
DE-117 Low/Middle Dose ophthalmic solutionAlso: DE-117Low/Middle Dose DE-117	Drug	DE-117 Low/Middle Dose ophthalmic solution
DE-117 Middle Dose ophthalmic solutionAlso: DE-117Middle Dose DE-117	Drug	DE-117 Middle Dose ophthalmic solution
DE-117 Middle/High Dose ophthalmic solutionAlso: DE-117Middle/High Dose DE-117	Drug	DE-117 Middle/High Dose ophthalmic solution
DE-117 High Dose ophthalmic solutionAlso: DE-117High Dose DE-117	Drug	DE-117 High Dose ophthalmic solution
latanoprost ophthalmic solution 0.005%Also: latanoprost0.005% latanoprost	Drug	latanoprost ophthalmic solution 0.005%

Primary outcome

Intraocular pressure (mmHg)
Time frame: Day 91
Intraocular pressure (mmHg) measurements will be collected using Goldmann applanation tonometry

1 secondary outcome

Number of Subjects with Adverse Events as a Measure of Safety and Tolerability
Time frame: Day 1, Day 8, Day 15, Day 31, Day 61 and Day 91

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 18 Apr 2018.

Related trials for Open-angle Glaucoma

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
RecruitingObservational study
PRESERFLO™ MicroShunt XI Observational PMCF Study With no Control Group
Primary Open Angle Glaucoma
RecruitingPhase 4
Adaptive Optics OCT Evaluation of Rhopressa's Effects on the Retinal Ganglion Cells in Glaucoma Patients
Open Angle Glaucoma (OAG), Glaucoma
Active, not recruitingObservational study
Impact of Glaucoma and Visual Field Loss on Life Space
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.

14 sites 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 11 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 18 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 sites in United States. 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 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.

What does the primary outcome measure?

Intraocular pressure (mmHg) (time frame: Day 91). 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 NCT02179008.

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 18 Apr 2018; AzTrials last refreshed its copy on 31 Oct 2026.