GlaucomaNCT00824824

Effect of Cosopt Versus Combigan on Retinal Vascular Autoregulation in Primary Open Angle Glaucoma (POAG)

A study testing Dorzolamide 2%-timolol 0.5% and Brimonidine 0.2%-0.5% timolol 0.5 in people with Glaucoma, run by Massachusetts Eye and Ear Infirmary at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 40 to 80 years
Conditions the study is for: Glaucoma
What is being tested?: Dorzolamide 2%-timolol 0.5% and Brimonidine 0.2%-0.5% timolol 0.5
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 21 participants
Where: 1 siteUnited States
Study dates: Jan 2009to Aug 2012
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 40 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

POAG
Age 40 to 80 years
Untreated IOP greater than 21 mm Hg

Who cannot join

More than two IOP lowering medications
Exfoliation or pigment dispersion syndrome
Diabetic retinopathy
History of ocular surgery

Trial locations and contacts

1 site in 1 country.

United States1 site

Massachusetts Eye and Ear Infirmary
Boston, Massachusetts, 02114

Other trials in United States

About this study

We have completed a study in which we examined the response of the retinal circulation to changes in posture from sitting to lying down in patients with primary open angle glaucoma (POAG). This alteration in position produces changes in the local blood pressure at the entrance to the retinal vasculature. In a healthy retina, the vasculature adapts by dilating and constricting in order to maintain a steady blood flow rate. In an eye with POAG, this often does not occur. As a result, there are large fluctuations in blood flow which may produce the retinal neuronal damage associated with glaucoma.

The purpose of this study is to demonstrate that topical anti-glaucoma treatments with agents that have vasoactive as well as IOP-lowering effects can have a beneficial effect on maintaining a steady retinal blood flow rate even when there are changes in local blood pressure.

Conditions: Glaucoma
Being tested: Dorzolamide 2%-timolol 0.5%, Brimonidine 0.2%-0.5% timolol 0.5
Keywords: Retinal Vascular Autoregulation
Medical subject headings: Glaucoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Dorzolamide 2%-timolol 0.5%Drug
Also called Cosopt, RVD intervention after run-in on timolol 0.5% bid OU
BID OU for 6 weeks
Brimonidine 0.2%-0.5% timolol 0.5Drug
Also called Combigan, RVD intervention after run-in on timolol 0.5% bid OU
BID OU for 6 weeks

Study groups in NCT00824824
Study group	Role	What they receive
Brimonidine 0.2%-timolol 0.5% arm	Experimental	Patients using timolol were switched to brimonidine tartrate / timolol maleate 0.2%/05% 1 get BID OU for six weeks. Receives: Drug: Brimonidine 0.2%-0.5% timolol 0.5
Dorzolamide 2%-timolol 0.5% arm	Active comparator	Patients using timolol were switched ti dorzolamide hydrochloride / timolol 0.5% 2%/0.5% bid OU for six weeks Receives: Drug: Dorzolamide 2%-timolol 0.5%

What is being measured

The primary outcome is the main question the study is designed to answer.

Presence of Retinal Vascular Dysregulation (RVD)
We determined whether RVD was present in the following way. The difference between the retinal blood flow measured while reclining for 30 minutes and the baseline retinal blood flow measured while seated was calculated. In a previous study, we found that among healthy subjects the change in the blood flow while reclining compared to baseline was +6.5% ± 12%. For this study, we defined the normal range of blood flow autoregulation as ± 2 standard deviations about the mean percentage change found in the control group in the initial study (6.5% ± 24.0%); that is, as -17.5% to +30.5%. Participants with a change in retinal blood flow induced by posture change outside this range were randomized to either dorzolamide-timolol fixed combination BID OU or brimonidine-timolol fixed combination BID OU for 6 weeks.
Measured: 6 weeks post treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2009Aug 2012

First posted19 Jan 2009 (estimated)
Study startJan 2009
Primary completionAug 2012
Study completionAug 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
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: Basic science
Allocation: Randomised
Intervention model: Single group
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 21 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00824824
Sponsor's protocol ID: 08-12-057
Status last verified: Mar 2017
First submitted: 16 Jan 2009
Last updated: 4 Apr 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No

Publications

Feke GT, Pasquale LR. Retinal blood flow response to posture change in glaucoma patients compared with healthy subjects. Ophthalmology. 2008 Feb;115(2):246-52. doi: 10.1016/j.ophtha.2007.04.055. Epub 2007 Aug 8.
PubMed 17689612

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
Implementing AI-based Glaucoma Screening Within Federally Qualified Health Centers
Glaucoma, Ocular Hypertension
Not yet recruiting
AI-Assisted vs Conventional Teleglaucoma Referral
Glaucoma
Recruiting
Brain Stimulation Effects on Orientation and Mobility Skills in Adults With Vision Impairment
Retinitis Pigmentosa (RP), Rod Cone Dystrophy
Recruiting
Automated Applanation Tonometry - Updated
Glaucoma, Glaucoma, Suspect
RecruitingPhase 2
A Phase 2a Study Comparing the Efficacy, Safety and Tolerability of Pregabalin Eye Drops Comparing With Timolol Eye Drops in Adults With Glaucoma or High Eye Pressure.
Primary Open - Angle Glaucoma (POAG), Ocular Hypertension (OHT)

All Glaucoma trials

Study at a glance

From the registry record, last updated by the sponsor on 4 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effect of Cosopt Versus Combigan on Retinal Vascular Autoregulation in Primary Open Angle Glaucoma (POAG)
ClinicalTrials.gov ID: NCT00824824
Acronym / sponsor ID: 08-12-057
Conditions: Glaucoma
Keywords: Retinal Vascular Autoregulation
Study type: Interventional
Recruitment status: Completed
Enrolment: 21 participants (actual)
Lead sponsor: Massachusetts Eye and Ear InfirmaryUniversity, hospital or other
Study start: Jan 2009
Primary completion: Aug 2012 (actual)
Study completion: Aug 2012 (actual)
First posted: 19 Jan 2009 (estimated)
Results: Posted 28 Oct 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Single group
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Brimonidine 0.2%-timolol 0.5% arm	Experimental	Drug: Brimonidine 0.2%-0.5% timolol 0.5Patients using timolol were switched to brimonidine tartrate / timolol maleate 0.2%/05% 1 get BID OU for six weeks.
Dorzolamide 2%-timolol 0.5% arm	Active comparator	Drug: Dorzolamide 2%-timolol 0.5%Patients using timolol were switched ti dorzolamide hydrochloride / timolol 0.5% 2%/0.5% bid OU for six weeks

Who may qualify

Ages: 40 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

POAG
Age 40 to 80 years
Untreated IOP greater than 21 mm Hg

Key exclusion criteria (4 listed)

More than two IOP lowering medications
Exfoliation or pigment dispersion syndrome
Diabetic retinopathy
History of ocular surgery

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
Dorzolamide 2%-timolol 0.5%Also: Cosopt, RVD intervention after run-in on timolol 0.5% bid OUBID OU for 6 weeks	Drug	Dorzolamide 2%-timolol 0.5% arm
Brimonidine 0.2%-0.5% timolol 0.5Also: Combigan, RVD intervention after run-in on timolol 0.5% bid OUBID OU for 6 weeks	Drug	Brimonidine 0.2%-timolol 0.5% arm

Primary outcome

Presence of Retinal Vascular Dysregulation (RVD)
Time frame: 6 weeks post treatment
We determined whether RVD was present in the following way. The difference between the retinal blood flow measured while reclining for 30 minutes and the baseline retinal blood flow measured while seated was calculated. In a previous study, we found that among healthy subjects the change in the blood flow while reclining compared to baseline was +6.5% ± 12%. For this study, we defined the normal range of blood flow autoregulation as ± 2 standard deviations about the mean percentage change found in the control group in the initial study (6.5% ± 24.0%); that is, as -17.5% to +30.5%. Participants with a change in retinal blood flow induced by posture change outside this range were randomized to either dorzolamide-timolol fixed combination BID OU or brimonidine-timolol fixed combination BID OU for 6 weeks.

Results and safety

Results posted to the registry on 28 Oct 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Dorzolamide-Timolol Then Brimonidine-Timolol	4	4
Brimonidine-Timolol Then Dorzolamide-Timolol	3	3

Primary outcome: Presence of Retinal Vascular Dysregulation (RVD)

Time frame: 6 weeks post treatment. Number. Unit: Participants

Measure	Dorzolamide-Timolol n = 7	Brimonidine-Timolol n = 6
Value	7	4

Population analysed: 21 participants were tested for RVD after 6 weeks of timolol treatment. Of the 21 participants who were tested, 7 had RVD and were randomized to Dorzolamide-Timolol and Brimonidine-Timolol; 14 had normal autoregulation. One participant was removed from the analysis in the Brimonidine-Timolol arm due to technical difficulties with equipment.

Adverse events

Time frame: The time period of the entire study.. Other adverse events reported at 3.8% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Dorzolamide-Timolol Then Brimonidine-Timolol	0 of 4 (0%)	0 of 4 (0%)	Not reported
Brimonidine-Timolol Then Dorzolamide-Timolol	0 of 3 (0%)	0 of 3 (0%)	Not reported

Limitations and caveats (from the sponsor): A potential limitation of this study is that no washout period occurred because the 6-week treatment periods extended beyond the typical 2-week washout period for dorzolamide and the 3-week washout period for brimonidine.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 17689612Feke GT, Pasquale LR. Retinal blood flow response to posture change in glaucoma patients compared with healthy subjects. Ophthalmology. 2008 Feb;115(2):246-52. doi: 10.1016/j.ophtha.2007.04.055. Epub 2007 Aug 8.
Individual participant dataSharing planned: No

Related trials for Glaucoma

Recruiting
Implementing AI-based Glaucoma Screening Within Federally Qualified Health Centers
Glaucoma, Ocular Hypertension
Not yet recruiting
AI-Assisted vs Conventional Teleglaucoma Referral
Glaucoma
Recruiting
Brain Stimulation Effects on Orientation and Mobility Skills in Adults With Vision Impairment
Retinitis Pigmentosa (RP), Rod Cone Dystrophy
Recruiting
Automated Applanation Tonometry - Updated
Glaucoma, Glaucoma, Suspect
RecruitingPhase 2
A Phase 2a Study Comparing the Efficacy, Safety and Tolerability of Pregabalin Eye Drops Comparing With Timolol Eye Drops in Adults With Glaucoma or High Eye Pressure.
Primary Open - Angle Glaucoma (POAG), Ocular Hypertension (OHT)

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.

Louis Pasquale principal investigator

Mass Eye and Ear Infirmary

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Dorzolamide 2%-timolol 0.5% and Brimonidine 0.2%-0.5% timolol 0.5 in people with Glaucoma, run by Massachusetts Eye and Ear Infirmary 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 3 inclusion and 4 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 4 Apr 2017. 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?

Yes. Results are posted in the registry (first posted 28 Oct 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Presence of Retinal Vascular Dysregulation (RVD) (time frame: 6 weeks post treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00824824, which also lists 1 linked publication.

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 4 Apr 2017.