Open-angle GlaucomaPhase 1/2NCT01279083
Safety and Efficacy Trial to Treat Open-Angle Glaucoma or Ocular Hypertension
A Phase 1/2 study testing DE-112 and Timolol Maleate Solution in people with Open-angle Glaucoma and Ocular Hypertension, run by Santen Inc. at 2 sites in United States.
Trial summary
To investigate the safety and efficacy of DE-112 in lowering intraocular pressure in subjects with primary open-angle glaucoma or ocular hypertension. 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-112 and Timolol Maleate Solution
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 147 participants
- Where
- 2 sitesUnited States
- Study dates
- Jan 2011to Feb 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
- Provide signed, written informed consent
- 18 yeas of age and older
- Diagnosed with primary open-angle glaucoma or ocular hypertension
- Female subject of childbearing potential must utilize reliable contraceptive throughout the study and have a negative urine pregnancy test prior to enrollment into this study
- Meet specific Visit 2, Day 0 (Baseline)criteria at baseline
Who cannot join
- 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
2 sites in 1 country.
United States2 sites
Study site
Austin, Texas, 78731
Study site
San Antonio, Texas, 78207
About this study
Official title: A Phase I/II Dose Escalation Safety and Efficacy Trial of DE-112 Ophthalmic Solution in Subjects With Primary Open-Angle Glaucoma or Ocular Hypertension
To investigate the safety and efficacy of DE-112 in lowering intraocular pressure in subjects with primary open-angle glaucoma or ocular hypertension.
Read the detailed description
This study will be conducted in two stages. Stage One is an open-label, adaptive dose-selection, safety and efficacy trial of up to four concentrations of DE-112 ophthalmic solution enrolling a total of 24 subjects.
Stage Two of the study is a randomized, double-masked, placebo- and active-controlled, parallel-group, multi-center trial comparing the efficacy and safety of two concentrations of DE-112 ophthalmic solution with placebo and timolol enrolling a total of 120 subjects.
- Conditions
- Open-angle Glaucoma, Ocular Hypertension
- Being tested
- DE-112, DE-112 Vehicle Solution, Timolol Maleate Solution
- 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-112Drug
Topical ocular solution
DE-112Drug
Topical ocular solution
DE-112Drug
Topical ocular solution
DE-112Drug
Topical ocular solution
DE-112 Vehicle SolutionDrug
Topical ocular solution
Timolol Maleate SolutionDrug
Topical ocular solution
| Study group | Role | What they receive |
|---|---|---|
| Concentration 1 | Experimental | Not described Receives: Drug: DE-112 |
| Concentration 2 | Experimental | Not described Receives: Drug: DE-112 |
| Concentration 3 | Experimental | Not described Receives: Drug: DE-112 |
| Concentration 4 | Experimental | Not described Receives: Drug: DE-112 |
| Vehicle Solution | Placebo comparator | Not described Receives: Drug: DE-112 Vehicle Solution |
| Timolol Maleate Ophthalmic Solution | Active comparator | Not described Receives: Drug: Timolol Maleate Solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraocular pressure (IOP)
Change from baseline in mean diurnal IOP
Measured: 29 days
Secondary outcomes (1)
Intraocular pressure (IOP)
Percent change from baseline in mean diurnal IOP
Measured: 29 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2011 (estimated)
- Study startJan 2011
- Primary completionNov 2011
- Study completionFeb 2012
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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 147 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
- NCT01279083
- Sponsor's protocol ID
- 29-001
- Status last verified
- Dec 2012
- First submitted
- 14 Jan 2011
- Last updated
- 17 Dec 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II Dose Escalation Safety and Efficacy Trial of DE-112 Ophthalmic Solution in Subjects With Primary Open-Angle Glaucoma or Ocular Hypertension
- ClinicalTrials.gov ID
- NCT01279083
- Acronym / sponsor ID
- 29-001
- Conditions
- Open-angle Glaucoma, Ocular Hypertension
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 147 participants (actual)
- Lead sponsor
- Santen Inc.Industry (pharma, biotech, devices)
- Study start
- Jan 2011
- Primary completion
- Nov 2011 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 19 Jan 2011 (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 safety and efficacy of DE-112 in lowering intraocular pressure in subjects with primary open-angle glaucoma or ocular hypertension.
Detailed description
This study will be conducted in two stages. Stage One is an open-label, adaptive dose-selection, safety and efficacy trial of up to four concentrations of DE-112 ophthalmic solution enrolling a total of 24 subjects.
Stage Two of the study is a randomized, double-masked, placebo- and active-controlled, parallel-group, multi-center trial comparing the efficacy and safety of two concentrations of DE-112 ophthalmic solution with placebo and timolol enrolling a total of 120 subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Concentration 1 | Experimental | Drug: DE-112 |
| Concentration 2 | Experimental | Drug: DE-112 |
| Concentration 3 | Experimental | Drug: DE-112 |
| Concentration 4 | Experimental | Drug: DE-112 |
| Vehicle Solution | Placebo comparator | Drug: DE-112 Vehicle Solution |
| Timolol Maleate Ophthalmic Solution | Active comparator | Drug: Timolol Maleate Solution |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Provide signed, written informed consent
- 18 yeas of age and older
- Diagnosed with primary open-angle glaucoma or ocular hypertension
- Female subject of childbearing potential must utilize reliable contraceptive throughout the study and have a negative urine pregnancy test prior to enrollment into this study
- Meet specific Visit 2, Day 0 (Baseline)criteria at baseline
Key exclusion criteria (2 listed)
- 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-112Topical ocular solution | Drug | Concentration 1 |
| DE-112Topical ocular solution | Drug | Concentration 2 |
| DE-112Topical ocular solution | Drug | Concentration 3 |
| DE-112Topical ocular solution | Drug | Concentration 4 |
| DE-112 Vehicle SolutionTopical ocular solution | Drug | Vehicle Solution |
| Timolol Maleate SolutionTopical ocular solution | Drug | Timolol Maleate Ophthalmic Solution |
Primary outcome
Intraocular pressure (IOP)
Time frame: 29 days
Change from baseline in mean diurnal IOP
1 secondary outcome
Intraocular pressure (IOP)
Time frame: 29 days
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 17 Dec 2012.
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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.
2 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-112 and Timolol Maleate Solution in people with Open-angle Glaucoma and Ocular Hypertension, run by Santen Inc. at 2 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 5 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 17 Dec 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
Intraocular pressure (IOP) (time frame: 29 days). 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 17 Dec 2012.