Glaucoma, Open-AnglePhase 1/2NCT00753168
Phase 1-2 Evaluation of OT-730 Eye Drops in Reducing the Intraocular Pressure in Patients With Ocular Hypertension or Open-Angle Glaucoma
A Phase 1/2 study testing OT-730 ophthalmic solution and timolol maleate ophthalmic solution in people with Glaucoma, Open-Angle and Ocular Hypertension, run by Othera Pharmaceuticals at 5 sites in United States.
Trial summary
The purpose of this study is to evaluate the safety and potential efficacy of a new drug, OT-730 ophthalmic solution (eye drops), in reducing intraocular pressure in the eyes of patients with open angle glaucoma or ocular hypertension. It will be compared with commercial timolol and placebo eye drops. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Glaucoma, Open-Angle, Ocular Hypertension
- What is being tested?
- OT-730 ophthalmic solution and timolol maleate ophthalmic solution
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 5 sitesUnited States
- Study dates
- Sep 2008to Dec 2008
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- healthy subjects, 18 to 80 years of age, any gender
- diagnosis of primary open angle, pseudoexfoliative or pigmentary glaucoma or ocular hypertension
Who cannot join
- have VA worse than 20/200,
- cataract that compromises visualization of fundus,
- history of lack of response to ocular beta blocker therapy,
- uncontrolled intraocular pressure,
- angle closure glaucoma or occludable angles,
- retinal detachment, macular hole, progressive vision loss, any progressive retinal disease or neurologic disease other than glaucoma that is likely to worsen visual field or acuity during the course of the study,
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- a history of, or any current condition contraindicated with use of a beta blocker (e.g., chronic obstructive pulmonary disease, bronchial asthma, congestive heart failure, myasthenia gravis, hypoglycemia, bradycardia, etc),
- chronic use of steroids,
- any disease that, in the opinion of the investigator, may put the patient at significant risk,
- taking systemic beta blockers
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Study site
Artesia, California
Study site
Charlotte, North Carolina
Study site
High Point, North Carolina
Study site
Mt. Pleasant, South Carolina
Study site
Roswell, Georgia
About this study
Official title: A Randomized, Parallel-Group, Multi-Center, Investigator-Masked, Active-and Placebo-Controlled, Phase 1-2 Evaluation of the Safety and Efficacy of OT-730 Ophthalmic Solution in Reducing the Intraocular Pressure in Subjects With Ocular Hypertension or Open-Angle Glaucoma
The purpose of this study is to evaluate the safety and potential efficacy of a new drug, OT-730 ophthalmic solution (eye drops), in reducing intraocular pressure in the eyes of patients with open angle glaucoma or ocular hypertension. It will be compared with commercial timolol and placebo eye drops.
Read the detailed description
Glaucoma is a group of diseases of the eye that can result in irreversible vision loss due to damage to the optic nerve. Elevated intraocular pressure (IOP) is one factor associated with glaucoma. Currently-available medication used to lower IOP includes beta-blocking agents, which can have undesirable side effects on the cardiac and respiratory systems.
The OT-730 ophthalmic solution contains OT-730, a prodrug that, when applied as an eyedrop, metabolizes to OT-705, an active beta blocker. The OT-730 ophthalmic solution is being studied to see how well it lowers IOP in patients with a diagnosis of open angle glaucoma or ocular hypertension. It will be compared with a well known beta blocker, timolol maleate ophthalmic solution, and with a placebo eye drop, in order to assess its ability to lower IOP without the typical side effects of other beta blockers.
- Conditions
- Glaucoma, Open-Angle, Ocular Hypertension
- Being tested
- OT-730 ophthalmic solution, timolol maleate ophthalmic solution, OT-730 placebo
- Keywords
- glaucoma, open angle, ocular hypertension, beta blocker, beta adrenergic, intraocular pressure
- 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.
OT-730 ophthalmic solutionDrug
one eye drop twice daily
timolol maleate ophthalmic solutionDrug
one eye drop twice daily
OT-730 placeboDrug
one eye drop twice daily
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | OT-730 ophthalmic solution Receives: Drug: OT-730 ophthalmic solution |
| 2 | Active comparator | timolol maleate ophthalmic solution Receives: Drug: timolol maleate ophthalmic solution |
| 3 | Placebo comparator | placebo eye drops Receives: Drug: OT-730 placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess the safety profile of OT-730
Measured: 8 days
Change from baseline in intraocular pressure
Measured: Day 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2008 (estimated)
- Study startSep 2008
- Primary completionDec 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glaucoma, Open-AngleStudies 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
- Investigator, Outcomes assessor
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Othera Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00753168
- Sponsor's protocol ID
- OT-730-C01
- Status last verified
- Jan 2009
- First submitted
- 8 Sep 2008
- Last updated
- 7 Jan 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Parallel-Group, Multi-Center, Investigator-Masked, Active-and Placebo-Controlled, Phase 1-2 Evaluation of the Safety and Efficacy of OT-730 Ophthalmic Solution in Reducing the Intraocular Pressure in Subjects With Ocular Hypertension or Open-Angle Glaucoma
- ClinicalTrials.gov ID
- NCT00753168
- Acronym / sponsor ID
- OT-730-C01
- Conditions
- Glaucoma, Open-Angle, Ocular Hypertension
- Keywords
- glaucoma, open angle, ocular hypertension, beta blocker, beta adrenergic, intraocular pressure
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Othera PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Sep 2008
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 16 Sep 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.
The purpose of this study is to evaluate the safety and potential efficacy of a new drug, OT-730 ophthalmic solution (eye drops), in reducing intraocular pressure in the eyes of patients with open angle glaucoma or ocular hypertension. It will be compared with commercial timolol and placebo eye drops.
Detailed description
Glaucoma is a group of diseases of the eye that can result in irreversible vision loss due to damage to the optic nerve. Elevated intraocular pressure (IOP) is one factor associated with glaucoma. Currently-available medication used to lower IOP includes beta-blocking agents, which can have undesirable side effects on the cardiac and respiratory systems.
The OT-730 ophthalmic solution contains OT-730, a prodrug that, when applied as an eyedrop, metabolizes to OT-705, an active beta blocker. The OT-730 ophthalmic solution is being studied to see how well it lowers IOP in patients with a diagnosis of open angle glaucoma or ocular hypertension. It will be compared with a well known beta blocker, timolol maleate ophthalmic solution, and with a placebo eye drop, in order to assess its ability to lower IOP without the typical side effects of other beta blockers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: OT-730 ophthalmic solutionOT-730 ophthalmic solution |
| 2 | Active comparator | Drug: timolol maleate ophthalmic solutiontimolol maleate ophthalmic solution |
| 3 | Placebo comparator | Drug: OT-730 placeboplacebo eye drops |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- healthy subjects, 18 to 80 years of age, any gender
- diagnosis of primary open angle, pseudoexfoliative or pigmentary glaucoma or ocular hypertension
Key exclusion criteria (10 listed)
- have VA worse than 20/200,
- cataract that compromises visualization of fundus,
- history of lack of response to ocular beta blocker therapy,
- uncontrolled intraocular pressure,
- angle closure glaucoma or occludable angles,
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 |
|---|---|---|
| OT-730 ophthalmic solutionone eye drop twice daily | Drug | 1 |
| timolol maleate ophthalmic solutionone eye drop twice daily | Drug | 2 |
| OT-730 placeboone eye drop twice daily | Drug | 3 |
Primary outcome
Assess the safety profile of OT-730
Time frame: 8 days
Change from baseline in intraocular pressure
Time frame: Day 6
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 7 Jan 2009.
- Othera Pharmaceuticals, Inc. websiteLink provided by the sponsor.
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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.
5 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 OT-730 ophthalmic solution and timolol maleate ophthalmic solution in people with Glaucoma, Open-Angle and Ocular Hypertension, run by Othera Pharmaceuticals at 5 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 2 inclusion and 10 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 7 Jan 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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?
Assess the safety profile of OT-730 (time frame: 8 days). The study lists 2 primary outcomes in all. 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 7 Jan 2009.