Open-Angle GlaucomaPhase 2NCT00650338
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 Inc. at 14 sites in United States.
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 18 years and older
- 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
- 165 participants
- Where
- 14 sitesUnited States
- Study dates
- Mar 2008to Oct 2008
- 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
- Provided signed, written informed consent.
- Diagnosed with primary open-angle glaucoma or ocular hypertension.
- 18 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
14 sites in 1 country.
14 sites in 1 country
United States14 sites
Sall Research Medical Center
Artesia, California, 90701
Keystone Research, Ltd.
Austin, Texas, 78731
Seidenberg Protzko Eye Associates
Bel Air, Maryland, 21014
Cornerstone Eye Care
High Point, North Carolina, 27262
USC Department of Ophthalmology
Los Angeles, California, 90033
Virginia Eye Consultants
Norfolk, Virginia, 23507
University of Nebraska Medical Center
Omaha, Nebraska, 68198-5540
Associated Glaucoma Consultants
Philadelphia, Pennsylvania, 19107
Rochester Ophthalmological Group, PC
Rochester, New York, 14618
David Shulman, MD P-A
San Antonio, Texas, 78209
Eye Clinics of South Texas
San Antonio, Texas, 78209
Medical Center Ophthalmology Associates
San Antonio, Texas, 78240
East Florida Eye Institute
Stuart, Florida, 34994
Wolstan Eye Associates
Torrance, California, 90505
About this study
Official title: A Randomized, Double-masked, Placebo- and Active- Controlled, Parallel-group, Multi-center, Dose-response Trial of DE-104 Ophthalmic Solution in Subjects With Primary 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, Placebo, 0.005% latanoprost
- 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
Topical ocular application
DE-104 ophthalmic solution, medium concentrationDrug
Topical ocular application
DE-104 ophthalmic solution, high concentrationDrug
Topical ocular application
PlaceboDrug
placebo
0.005% latanoprostDrug
Topical ocular application
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | <described in intervention> Receives: Drug: DE-104 ophthalmic solution, low concentration |
| 2 | Experimental | <described in intervention> Receives: Drug: DE-104 ophthalmic solution, medium concentration |
| 3 | Experimental | <described in intervention> Receives: Drug: DE-104 ophthalmic solution, high concentration |
| 4 | Placebo comparator | <described in intervention> Receives: Drug: Placebo |
| 5 | Active comparator | <described intervention> Receives: Drug: 0.005% latanoprost |
What is being measured
The primary outcome is the main question the study is designed to answer.
To investigate the dose-response relationship of DE-104 in lowering intraocular pressure (IOP)
Measured: 28 days
Secondary outcomes (1)
To compare the safety and efficacy of DE-104 ophthalmic solution with placebo and 0.005% latanoprost.
Measured: 35 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2008 (estimated)
- Study startMar 2008
- Primary completionSep 2008
- Study completionOct 2008
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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 165 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Santen Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00650338
- Sponsor's protocol ID
- 27-002
- Status last verified
- Nov 2011
- First submitted
- 27 Mar 2008
- Last updated
- 3 Nov 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-masked, Placebo- and Active- Controlled, Parallel-group, Multi-center, Dose-response Trial of DE-104 Ophthalmic Solution in Subjects With Primary Open-angle Glaucoma or Ocular Hypertension
- ClinicalTrials.gov ID
- NCT00650338
- Acronym / sponsor ID
- 27-002
- Conditions
- Open-Angle Glaucoma, Ocular Hypertension
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 165 participants (estimated)
- Lead sponsor
- Santen Inc.Industry (pharma, biotech, devices)
- Study start
- Mar 2008
- Primary completion
- Sep 2008 (actual)
- Study completion
- Oct 2008 (actual)
- First posted
- 1 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: DE-104 ophthalmic solution, low concentration<described in intervention> |
| 2 | Experimental | Drug: DE-104 ophthalmic solution, medium concentration<described in intervention> |
| 3 | Experimental | Drug: DE-104 ophthalmic solution, high concentration<described in intervention> |
| 4 | Placebo comparator | Drug: Placebo<described in intervention> |
| 5 | Active comparator | Drug: 0.005% latanoprost<described intervention> |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Provided signed, written informed consent.
- Diagnosed with primary open-angle glaucoma or ocular hypertension.
- 18 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-104 ophthalmic solution, low concentrationTopical ocular application | Drug | 1 |
| DE-104 ophthalmic solution, medium concentrationTopical ocular application | Drug | 2 |
| DE-104 ophthalmic solution, high concentrationTopical ocular application | Drug | 3 |
| Placeboplacebo | Drug | 4 |
| 0.005% latanoprostTopical ocular application | Drug | 5 |
Primary outcome
To investigate the dose-response relationship of DE-104 in lowering intraocular pressure (IOP)
Time frame: 28 days
1 secondary outcome
To compare the safety and efficacy of DE-104 ophthalmic solution with placebo and 0.005% latanoprost.
Time frame: 35 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 3 Nov 2011.
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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.
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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 Inc. at 14 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 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 3 Nov 2011. 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. 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.
What does the primary outcome measure?
To investigate the dose-response relationship of DE-104 in lowering intraocular pressure (IOP) (time frame: 28 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 3 Nov 2011.