GlaucomaPhase 2NCT01345448
Intraocular Pressure (IOP) Lowering Efficacy of Transdermal Brimonidine Therapy
A Phase 2 study testing Brimonidine in people with Glaucoma, run by Nanduri, Padma, M.D., FACS at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the safety and effectiveness in lowering intraocular pressure (IOP) utilizing an experimental lotion containing 0.1% Brimonidine that is applied to the outside of one eyelid. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Glaucoma
- What is being tested?
- Brimonidine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2011to Jul 2011
- 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 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients with a clinical diagnosis of stable Chronic Open Angle Glaucoma and stable Vital signs who are controlled on a stable dose of a single IOP lowering agent and who have demonstrated stable target intraocular pressure for a minimum of 3 months.
- Male or Female patients aged at least 18 years of age.
- Females of childbearing potential must use a reliable form of contraception throughout the study period such as celibacy, birth control pills, or condoms.
- A negative urine pregnancy test result at Screening and Baseline (Day 1) for women of childbearing potential
- Best-Corrected Visual Acuity of 20/800 or better in both eyes
- Written informed consent.
- Ability to follow instructions and likely to complete all study visits based upon patient factors such as cognition, reliability, motivation, and ability to obtain reliable transportation to study site.
Who cannot join
- Uncontrolled glaucoma
- Glaucoma requiring more than a single agent for IOP control
- Patients with a corneal thickness greater then 620 micrometers
- Female patients who are pregnant, nursing, or planning a pregnancy during the study
- Patient who has any situation or condition, which in the investigator's opinion, may put the patient at a significant risk, may confound the study result or may interfere significantly with the participation in the study
- Uncontrolled or labile hypertension
- At the conclusion of the washout period any study participant with an IOP lower than 22 or greater than 35 mmHg.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Eye Surgical and Medical Associates
Visalia, California, 93277
Michael Boone, MD, 559-627-9393, drboone@visaliaeyecare.com
Amy Smith, (559)627-9393, amys@visaliaeyecare.com
About this study
Official title: Study of Safety and IOP Lowering Efficacy of Transdermal Brimonidine Therapy
The purpose of this study is to evaluate the safety and effectiveness in lowering intraocular pressure (IOP) utilizing an experimental lotion containing 0.1% Brimonidine that is applied to the outside of one eyelid.
Read the detailed description
Glaucoma is the leading cause of irreversible blindness worldwide, with primary open-angle glaucoma the most common form of glaucoma. Vision loss is caused by damage to the optic nerve. The modern goals of glaucoma management are to avoid glaucomatous damage, nerve damage, preserve visual field and total quality of life for patients with minimal side effects.
Although intraocular pressure is only one of the major risk factors for glaucoma, lowering it via various pharmaceuticals and/or surgical techniques is currently the mainstay of glaucoma treatment. Intraocular pressure can be lowered with medication, usually eye drops. There are several different classes of medications to treat glaucoma with several different medications in each class. In order to prevent blindness from glaucoma, it is critical that patients take their glaucoma eye drops accurately and faithfully for the rest of their lives. Poor compliance with medications and follow-up visits is a major reason for vision loss in glaucoma patients. In addition, coordination involved in placing an eye drop in the eye is considerably more difficult and unpleasant to patients than many other therapies. Thus, localized transdermal eyelid lotion would create a leap in safety of drug delivery while at the same time rendering ocular drugs easy and non traumatic to use.
- Conditions
- Glaucoma
- Being tested
- Brimonidine, Placebo Lotion
- Keywords
- Glaucoma, Brimonidine, Transdermal
- Medical subject headings
- Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BrimonidineDrug
Also called Alphagan
0.1% Brimonidine Lotion, dosed once.
Placebo LotionDrug
Placebo Lotion dosed once.
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraocular Pressure
Measured: Day one, every hour for twelve hours.
Heart Rate
Measured: Day one, every hour for twelve hours.
Blood Pressure
Measured: Day one, every hour for twelve hours.
Intraocular Pressure
Measured: Day two twice, once in the AM, once in the PM.
Intraocular Pressure
Measured: Day seven, once.
Intraocular Pressure
Measured: Day fourteen, once.
Intraocular Pressure
Measured: Day twenty one, once.
Intraocular Pressure
Measured: Day twenty eight, once.
Heart Rate
Measured: Day two twice, once in the AM, once in the PM.
Heart Rate
Measured: Day seven, once.
Heart Rate
Measured: Day fourteen, once.
Heart Rate
Measured: Day twenty one, once.
Heart Rate
Measured: Day twenty eight, once.
Blood Pressure
Measured: Day two twice, once in the AM, once in the PM.
Blood Pressure
Measured: Day seven, once.
Blood Pressure
Measured: Day fourteen, once.
Blood Pressure
Measured: Day twenty one, once.
Blood Pressure
Measured: Day twenty eight, once.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2011 (estimated)
- Study startApr 2011
- Primary completionJul 2011 (estimated)
- Study completionJul 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- 22 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanduri, Padma, M.D., FACS
- Investigators
- Padma Nanduri, MD, Principal investigatorMichael Boone, MD, Study director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01345448
- Sponsor's protocol ID
- White Rabbit 2010-0001
- Status last verified
- Apr 2011
- First submitted
- 27 Apr 2011
- Last updated
- 2 May 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Safety and IOP Lowering Efficacy of Transdermal Brimonidine Therapy
- ClinicalTrials.gov ID
- NCT01345448
- Acronym / sponsor ID
- White Rabbit 2010-0001
- Conditions
- Glaucoma
- Keywords
- Glaucoma, Brimonidine, Transdermal
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 22 participants (estimated)
- Lead sponsor
- Nanduri, Padma, M.D., FACS
- Study start
- Apr 2011
- Primary completion
- Jul 2011 (estimated)
- Study completion
- Jul 2011 (estimated)
- First posted
- 2 May 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.
The purpose of this study is to evaluate the safety and effectiveness in lowering intraocular pressure (IOP) utilizing an experimental lotion containing 0.1% Brimonidine that is applied to the outside of one eyelid.
Detailed description
Glaucoma is the leading cause of irreversible blindness worldwide, with primary open-angle glaucoma the most common form of glaucoma. Vision loss is caused by damage to the optic nerve. The modern goals of glaucoma management are to avoid glaucomatous damage, nerve damage, preserve visual field and total quality of life for patients with minimal side effects.
Although intraocular pressure is only one of the major risk factors for glaucoma, lowering it via various pharmaceuticals and/or surgical techniques is currently the mainstay of glaucoma treatment. Intraocular pressure can be lowered with medication, usually eye drops. There are several different classes of medications to treat glaucoma with several different medications in each class. In order to prevent blindness from glaucoma, it is critical that patients take their glaucoma eye drops accurately and faithfully for the rest of their lives. Poor compliance with medications and follow-up visits is a major reason for vision loss in glaucoma patients. In addition, coordination involved in placing an eye drop in the eye is considerably more difficult and unpleasant to patients than many other therapies. Thus, localized transdermal eyelid lotion would create a leap in safety of drug delivery while at the same time rendering ocular drugs easy and non traumatic to use.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients with a clinical diagnosis of stable Chronic Open Angle Glaucoma and stable Vital signs who are controlled on a stable dose of a single IOP lowering agent and who have demonstrated stable target intraocular pressure for a minimum of 3 months.
- Male or Female patients aged at least 18 years of age.
- Females of childbearing potential must use a reliable form of contraception throughout the study period such as celibacy, birth control pills, or condoms.
- A negative urine pregnancy test result at Screening and Baseline (Day 1) for women of childbearing potential
- Best-Corrected Visual Acuity of 20/800 or better in both eyes
Key exclusion criteria (7 listed)
- Uncontrolled glaucoma
- Glaucoma requiring more than a single agent for IOP control
- Patients with a corneal thickness greater then 620 micrometers
- Female patients who are pregnant, nursing, or planning a pregnancy during the study
- Patient who has any situation or condition, which in the investigator's opinion, may put the patient at a significant risk, may confound the study result or may interfere significantly with the 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 |
|---|---|---|
| BrimonidineAlso: Alphagan0.1% Brimonidine Lotion, dosed once. | Drug | – |
| Placebo LotionPlacebo Lotion dosed once. | Drug | – |
Primary outcome
Intraocular Pressure
Time frame: Day one, every hour for twelve hours.
Heart Rate
Time frame: Day one, every hour for twelve hours.
Blood Pressure
Time frame: Day one, every hour for twelve hours.
Intraocular Pressure
Time frame: Day two twice, once in the AM, once in the PM.
Intraocular Pressure
Time frame: Day seven, once.
Intraocular Pressure
Time frame: Day fourteen, once.
Intraocular Pressure
Time frame: Day twenty one, once.
Intraocular Pressure
Time frame: Day twenty eight, once.
Heart Rate
Time frame: Day two twice, once in the AM, once in the PM.
Heart Rate
Time frame: Day seven, once.
Heart Rate
Time frame: Day fourteen, once.
Heart Rate
Time frame: Day twenty one, once.
Heart Rate
Time frame: Day twenty eight, once.
Blood Pressure
Time frame: Day two twice, once in the AM, once in the PM.
Blood Pressure
Time frame: Day seven, once.
Blood Pressure
Time frame: Day fourteen, once.
Blood Pressure
Time frame: Day twenty one, once.
Blood Pressure
Time frame: Day twenty eight, once.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 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.
Padma Nanduri, MD principal investigator
Michael Boone, MD study director
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Brimonidine in people with Glaucoma, run by Nanduri, Padma, M.D., FACS at 1 site 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 7 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 2 May 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Michael Boone, MD ((559)627-9393, drboone@visaliaeyecare.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intraocular Pressure (time frame: Day one, every hour for twelve hours.). The study lists 18 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 2 May 2011.