Glaucoma and Ocular HypertensionPhase 1/2NCT01654484
A Study Assessing the Safety and Efficacy of DE-117 Ophthalmic Solution in Patients With POAG or OHT
A Phase 1/2 study testing DE-117, 0.0015% tafluprost and DE-117 and 0.0015% tafluprost in people with Glaucoma and Ocular Hypertension, run by Santen Inc. at 10 sites in United States.
Trial summary
The purpose of this study is to investigate the safety and efficacy of up to three concentrations of DE-117 ophthalmic solution (Low Dose, Medium Dose, and High Dose) as monotherapy and as adjunctive therapy (DE-117 ophthalmic solution with 0.0015% tafluprost) in subjects with primary open-angle glaucoma or ocular… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glaucoma and Ocular Hypertension
- What is being tested?
- DE-117, 0.0015% tafluprost and DE-117 and 0.0015% tafluprost
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 10 sitesUnited States
- Study dates
- Jul 2012to Nov 2012
- Phase
- Phase 1/2
- 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
- Male or Female, 18 years of age or older
- Current diagnosis of primary open-angle glaucoma or ocular hypertension in both eyes
- Qualifying intraocular pressure (IOP) in at least one eye at Baseline
Who cannot join
- Closed/barely open anterior chamber angle or a history of acute angle closure in either eye
- Anticipate the need to initiate or modify medication (systemic or topical) that is known to affect intraocular pressure (IOP) during the study period
- Females who are pregnant, nursing or planning a pregnancy
- Presence of any abnormality or significant illness that could be expected to interfere with the study.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
Santen Investigational Site
Austin, Texas, 78731
Santen Investigational Site
Cleveland, Ohio, 44115
Santen Investigational Site
Deerfield Beach, Florida, 33064
Santen Investigational Site
Fort Worth, Texas, 76102
Santen Investigational Site
Largo, Florida, 33773
Santen Investigational Site
Morrow, Georgia, 30260
Santen Investigational Site
Newport Beach, California, 92663
Santen Investigational Site
Rochester, New York, 14618
Santen Investigational Site
Roswell, Georgia, 30076
Santen Investigational Site
San Antonio, Texas, 78240
About this study
Official title: A Phase I/II, Randomized, Observer-masked, Placebo-and Active-controlled, Parallel-group, Multi-center Study Assessing the Safety and Efficacy of DE-117 Ophthalmic Solution in Subjects With Primary Open-angle Glaucoma or Ocular Hypertension
The purpose of this study is to investigate the safety and efficacy of up to three concentrations of DE-117 ophthalmic solution (Low Dose, Medium Dose, and High Dose) as monotherapy and as adjunctive therapy (DE-117 ophthalmic solution with 0.0015% tafluprost) in subjects with primary open-angle glaucoma or ocular hypertension.
Read the detailed description
This is a two stage study.
Stage One will explore the dose response of three concentrations of DE-117 as monotherapy compared with 0.0015% tafluprost and placebo. The safety and efficacy of DE-117 as adjunctive therapy (with 0.0015% tafluprost) compared with 0.0015% tafluprost and placebo will also be evaluated. In addition, the additive effect of adjunctive therapy of each concentration will be compared with the corresponding monotherapy concentration.
Stage Two will assess the safety and efficacy of the optimal DE-117 concentration as monotherapy compared with 0.0015% tafluprost. The safety and efficacy of the optimal DE-117 concentration as adjunctive therapy (with 0.0015% tafluprost) compared with DE-117 monotherapy and 0.0015% tafluprost will also be evaluated.
- Conditions
- Glaucoma and Ocular Hypertension
- Being tested
- DE-117, 0.0015% tafluprost, DE-117 and 0.0015% tafluprost, Placebo
- Medical subject headings
- Glaucoma, Ocular Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DE-117Drug
Ophthalmic Solution, QD, 28 Days
0.0015% tafluprostDrug
Ophthalmic Solution, QD, 28 days
DE-117 and 0.0015% tafluprostDrug
Ophthalmic Solutions, QD, 28 days
PlaceboDrug
Ophthalmic Solution, QD, 28 days
| Study group | Role | What they receive |
|---|---|---|
| Low Dose DE-117 | Experimental | Monotherapy Receives: Drug: DE-117 |
| Medium Dose DE-117 | Experimental | Monotherapy Receives: Drug: DE-117 |
| High Dose DE-117 | Experimental | Monotherapy Receives: Drug: DE-117 |
| Low Dose DE-117 and 0.0015% tafluprost | Experimental | Adjunctive Therapy Receives: Drug: DE-117 and 0.0015% tafluprost |
| Med. Dose DE-117 and 0.0015% tafluprost | Experimental | Adjunctive Therapy Receives: Drug: DE-117 and 0.0015% tafluprost |
| High Dose DE-117 and 0.0015% tafluprost | Experimental | Adjunctive Therapy Receives: Drug: DE-117 and 0.0015% tafluprost |
| 0.0015% tafluprost | Active comparator | Monotherapy Receives: Drug: 0.0015% tafluprost |
| Placebo | Placebo comparator | Monotherapy Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in intraocular pressure (IOP) on Day 29 at each scheduled time point
Measured: Day 28 T0 (08:00 ±30 mins), T0+2 hrs, T0+4 hrs, T0+8 hrs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2012 (estimated)
- Study startJul 2012
- Primary completionNov 2012
- Study completionNov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glaucoma and Ocular HypertensionStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Santen Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01654484
- Sponsor's protocol ID
- 33-001
- Status last verified
- Apr 2018
- First submitted
- 27 Jul 2012
- Last updated
- 18 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
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
- A Phase I/II, Randomized, Observer-masked, Placebo-and Active-controlled, Parallel-group, Multi-center Study Assessing the Safety and Efficacy of DE-117 Ophthalmic Solution in Subjects With Primary Open-angle Glaucoma or Ocular Hypertension
- ClinicalTrials.gov ID
- NCT01654484
- Acronym / sponsor ID
- 33-001
- Conditions
- Glaucoma and Ocular Hypertension
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Santen Inc.Industry (pharma, biotech, devices)
- Study start
- Jul 2012
- Primary completion
- Nov 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 31 Jul 2012 (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 up to three concentrations of DE-117 ophthalmic solution (Low Dose, Medium Dose, and High Dose) as monotherapy and as adjunctive therapy (DE-117 ophthalmic solution with 0.0015% tafluprost) in subjects with primary open-angle glaucoma or ocular hypertension.
Detailed description
This is a two stage study.
Stage One will explore the dose response of three concentrations of DE-117 as monotherapy compared with 0.0015% tafluprost and placebo. The safety and efficacy of DE-117 as adjunctive therapy (with 0.0015% tafluprost) compared with 0.0015% tafluprost and placebo will also be evaluated. In addition, the additive effect of adjunctive therapy of each concentration will be compared with the corresponding monotherapy concentration.
Stage Two will assess the safety and efficacy of the optimal DE-117 concentration as monotherapy compared with 0.0015% tafluprost. The safety and efficacy of the optimal DE-117 concentration as adjunctive therapy (with 0.0015% tafluprost) compared with DE-117 monotherapy and 0.0015% tafluprost will also be evaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Low Dose DE-117 | Experimental | Drug: DE-117Monotherapy |
| Medium Dose DE-117 | Experimental | Drug: DE-117Monotherapy |
| High Dose DE-117 | Experimental | Drug: DE-117Monotherapy |
| Low Dose DE-117 and 0.0015% tafluprost | Experimental | Drug: DE-117 and 0.0015% tafluprostAdjunctive Therapy |
| Med. Dose DE-117 and 0.0015% tafluprost | Experimental | Drug: DE-117 and 0.0015% tafluprostAdjunctive Therapy |
| High Dose DE-117 and 0.0015% tafluprost | Experimental | Drug: DE-117 and 0.0015% tafluprostAdjunctive Therapy |
| 0.0015% tafluprost | Active comparator | Drug: 0.0015% tafluprostMonotherapy |
| Placebo | Placebo comparator | Drug: PlaceboMonotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male or Female, 18 years of age or older
- Current diagnosis of primary open-angle glaucoma or ocular hypertension in both eyes
- Qualifying intraocular pressure (IOP) in at least one eye at Baseline
Key exclusion criteria (4 listed)
- Closed/barely open anterior chamber angle or a history of acute angle closure in either eye
- Anticipate the need to initiate or modify medication (systemic or topical) that is known to affect intraocular pressure (IOP) during the study period
- Females who are pregnant, nursing or planning a pregnancy
- 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-117Ophthalmic Solution, QD, 28 Days | Drug | High Dose DE-117, Low Dose DE-117, Medium Dose DE-117 |
| 0.0015% tafluprostOphthalmic Solution, QD, 28 days | Drug | 0.0015% tafluprost |
| DE-117 and 0.0015% tafluprostOphthalmic Solutions, QD, 28 days | Drug | High Dose DE-117 and 0.0015% tafluprost, Low Dose DE-117 and 0.0015% tafluprost, Med. Dose DE-117 and 0.0015% tafluprost |
| PlaceboOphthalmic Solution, QD, 28 days | Drug | Placebo |
Primary outcome
Change from baseline in intraocular pressure (IOP) on Day 29 at each scheduled time point
Time frame: Day 28 T0 (08:00 ±30 mins), T0+2 hrs, T0+4 hrs, T0+8 hrs
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.
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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.
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing DE-117, 0.0015% tafluprost and DE-117 and 0.0015% tafluprost in people with Glaucoma and Ocular Hypertension, run by Santen Inc. at 10 sites in United States.
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 4 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 10 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. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Change from baseline in intraocular pressure (IOP) on Day 29 at each scheduled time point (time frame: Day 28 T0 (08:00 ±30 mins), T0+2 hrs, T0+4 hrs, T0+8 hrs). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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.