GlaucomaNCT00567411
Comparison of the Alpha-2 Agonists for Prevention of Intraocular Pressure Elevation After Selective Laser Trabeculoplasty
A study testing brimonidine 0.1% and Apraclonidine 0.5% in people with Glaucoma and Ocular Hypertension, run by Walter Reed Army Medical Center at 1 site in United States.
Trial summary
The purpose of the study is to compare the safety and efficacy of two drops used to lower eye pressure when given prior to a glaucoma laser procedure. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glaucoma, Ocular Hypertension
- What is being tested?
- brimonidine 0.1% and Apraclonidine 0.5%
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2006to Jun 2009
- Phase
- Interventional
- 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, at least 18 years of age
- Open Angle Glaucoma with inadequate intraocular pressure (IOP) control or evidence of progression (based on optic nerve head appearance and/or visual field changes) despite current medical therapy
- Ocular Hypertension requiring lowering of IOP
- ability to understand and provide informed consent to participate in this study and willingness to follow study instructions and likely to complete all required visits
Who cannot join
- inability to understand and provide informed consent to participate in this study
- inability/unwillingness to follow study instructions and complete all required visits
- Documented allergy to either brimonidine or iopidine
- Angle Closure Glaucoma
- Congenital/Juvenile Glaucoma
- Neovascular Glaucoma
- Active uveitis
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Walter Reed Army Medical Center
Washington D.C., District of Columbia, 20307
Vladimir S Yakopson, MD, 202-782-6965, vladimir.yakopson@na.amedd.army.mil
William Wilson, MD
About this study
The purpose of the study is to compare the safety and efficacy of two drops used to lower eye pressure when given prior to a glaucoma laser procedure.
Read the detailed description
This is a prospective randomized double blind trial of patients undergoing selective laser trabeculoplasty for primary open angle glaucoma and ocular hypertension. Enrolled patients are randomized to receive one drop of brimonidine 0.1% in one eye and one drop of apraclonidine 0.5% in the fellow eye. The trabecular meshwork in both eyes of each enrolled patient is treated 360 degrees at the same sitting. Intraocular pressure is measured in each eye one hour before applying the study medications and at one hour and one week after laser surgery.
- Conditions
- Glaucoma, Ocular Hypertension
- Being tested
- brimonidine 0.1%, Apraclonidine 0.5%
- Keywords
- Glaucoma, Laser, laser trabeculoplasty, selective laser trabeculoplasty, intraocular pressure
- 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.
brimonidine 0.1%Drug
1 drop, 1 hour prior to selective laser trabeculoplasty (SLT)
Apraclonidine 0.5%Drug
1 drop applied 1 hour prior to SLT
| Study group | Role | What they receive |
|---|---|---|
| I | Active comparator | Eyes receiving Apraclonidine 0.5% (Iopidine) prior to SLT Receives: Drug: Apraclonidine 0.5% |
| A | Active comparator | Eyes receiving Brimonidine 0.1% (Alphagan) prior to SLT Receives: Drug: brimonidine 0.1% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative IOP
Measured: 1 hour and 1 week post surgery
Secondary outcomes (1)
Overall IOP reduction post SLT
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2007 (estimated)
- Study startAug 2006
- Study completionJun 2009 (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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 43 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Walter Reed Army Medical Center
- Sponsor type
- US federal agency
- Investigators
- Vladimir S Yakopson, MD, Principal investigator, Walter Reed AMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00567411
- Sponsor's protocol ID
- WRAMC WU # 06-23016
- Status last verified
- Nov 2007
- First submitted
- 4 Dec 2007
- Last updated
- 5 Dec 2007
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Alpha-2 Agonists for Prevention of Intraocular Pressure Elevation After Selective Laser Trabeculoplasty
- ClinicalTrials.gov ID
- NCT00567411
- Acronym / sponsor ID
- WRAMC WU # 06-23016
- Conditions
- Glaucoma, Ocular Hypertension
- Keywords
- Glaucoma, Laser, laser trabeculoplasty, selective laser trabeculoplasty, intraocular pressure
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 43 participants (estimated)
- Lead sponsor
- Walter Reed Army Medical CenterUS federal agency
- Study start
- Aug 2006
- Study completion
- Jun 2009 (estimated)
- First posted
- 5 Dec 2007 (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 the study is to compare the safety and efficacy of two drops used to lower eye pressure when given prior to a glaucoma laser procedure.
Detailed description
This is a prospective randomized double blind trial of patients undergoing selective laser trabeculoplasty for primary open angle glaucoma and ocular hypertension. Enrolled patients are randomized to receive one drop of brimonidine 0.1% in one eye and one drop of apraclonidine 0.5% in the fellow eye. The trabecular meshwork in both eyes of each enrolled patient is treated 360 degrees at the same sitting. Intraocular pressure is measured in each eye one hour before applying the study medications and at one hour and one week after laser surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| I | Active comparator | Drug: Apraclonidine 0.5%Eyes receiving Apraclonidine 0.5% (Iopidine) prior to SLT |
| A | Active comparator | Drug: brimonidine 0.1%Eyes receiving Brimonidine 0.1% (Alphagan) prior to SLT |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- male or female, at least 18 years of age
- Open Angle Glaucoma with inadequate intraocular pressure (IOP) control or evidence of progression (based on optic nerve head appearance and/or visual field changes) despite current medical therapy
- Ocular Hypertension requiring lowering of IOP
- ability to understand and provide informed consent to participate in this study and willingness to follow study instructions and likely to complete all required visits
Key exclusion criteria (7 listed)
- inability to understand and provide informed consent to participate in this study
- inability/unwillingness to follow study instructions and complete all required visits
- Documented allergy to either brimonidine or iopidine
- Angle Closure Glaucoma
- Congenital/Juvenile Glaucoma
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 |
|---|---|---|
| brimonidine 0.1%1 drop, 1 hour prior to selective laser trabeculoplasty (SLT) | Drug | A |
| Apraclonidine 0.5%1 drop applied 1 hour prior to SLT | Drug | I |
Primary outcome
Postoperative IOP
Time frame: 1 hour and 1 week post surgery
1 secondary outcome
Overall IOP reduction post SLT
Time frame: 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2007.
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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.
Vladimir S Yakopson, MD principal investigator
Walter Reed AMC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing brimonidine 0.1% and Apraclonidine 0.5% in people with Glaucoma and Ocular Hypertension, run by Walter Reed Army Medical Center 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 4 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 5 Dec 2007. 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.
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 Vladimir S Yakopson, MD (202-782-6965, vladimir.yakopson@na.amedd.army.mil), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative IOP (time frame: 1 hour and 1 week post surgery). 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 5 Dec 2007.