An interventional study of Dorzolamide 2%-timolol 0.5% and Brimonidine 0.2%-0.5% timolol 0.5 in Glaucoma, sponsored by Massachusetts Eye and Ear Infirmary. Completed at 1 site in United States. Open to participants aged 40 Years to 80 Years. Per ClinicalTrials.gov, last updated 2017-04-04.
Sponsored by Massachusetts Eye and Ear Infirmary · Not applicable, Interventional, and Basic science
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.
1,818 studies on the registry are indexed under Glaucoma; 231 are open to participants now.
This study's enrollment of 21 is below the median of 65 across 1,272 interventional studies indexed under Glaucoma.
Browse Glaucoma studies →Massachusetts Eye and Ear Infirmary is the lead sponsor of 99 studies on the registry; 23 are open to participants now.
Of its 13 completed or terminated interventional studies of FDA-regulated products, 6 (46%) have results posted.
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Exclusion Criteria:
Patients using timolol were switched to brimonidine tartrate / timolol maleate 0.2%/05% 1 get BID OU for six weeks.
Drug: Brimonidine 0.2%-0.5% timolol 0.5
Patients using timolol were switched ti dorzolamide hydrochloride / timolol 0.5% 2%/0.5% bid OU for six weeks
Drug: Dorzolamide 2%-timolol 0.5%
BID OU for 6 weeks
Also known as: Cosopt, RVD intervention after run-in on timolol 0.5% bid OU
BID OU for 6 weeks
Also known as: Combigan, RVD intervention after run-in on timolol 0.5% bid OU
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.
Time frame: 6 weeks post treatment
A total of 21 primary open angle glaucoma patients were recruited for the study from the practices of Douglas J. Rhee, Angela V. Turalba, and Louis R. Pasquale at Massachusetts Eye and Ear Infirmary, Boston. Recruitment took place between February 13, 2009 and December 21, 2011.
| Milestone | Dorzolamide-Timolol Then Brimonidine-Timolol | Brimonidine-Timolol Then Dorzolamide-Timolol |
|---|---|---|
| Started | 4 | 3 |
| Completed | 4 | 3 |
| Not completed | 0 | 0 |
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.
| Participants | Dorzolamide-Timolol | Brimonidine-Timolol |
|---|---|---|
| Presence of Retinal Vascular Dysregulation (RVD) | 7 | 4 |
Collected over The time period of the entire study.. Non-serious events are listed at a 3.8% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Dorzolamide-Timolol Then Brimonidine-Timolol | — | 0/4 (0%) | 0/4 (0%) |
| Brimonidine-Timolol Then Dorzolamide-Timolol | — | 0/3 (0%) | 0/3 (0%) |
There are 14 subjects in this study whop have PAOG without RVD. There are 7 subjects with POAG with RVD. The 14 subjects without RVD did not continue in the two treament arms of this study.
| Age, Continuous(years) | Primary Open Angle Glaucoma | POAG With RVD | Total |
|---|---|---|---|
| Mean | 64.5 ± 8.2 | 60.0 ± 8.6 | 63 ± 8.3 |
| Sex: Female, Male(Participants) | Primary Open Angle Glaucoma | POAG With RVD | Total |
|---|---|---|---|
| Female | 3 | 2 | 5 |
| Male | 11 | 5 | 16 |
| Race (NIH/OMB)(Participants) | Primary Open Angle Glaucoma | POAG With RVD | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 1 | 0 | 1 |
| White | 13 | 7 | 20 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | Primary Open Angle Glaucoma | POAG With RVD | Total |
|---|---|---|---|
| United States | 14 | 7 | 21 |
Plan to share: No
This study is completed, as verified in Mar 2017. You cannot join it, but the record below documents what was studied.
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Massachusetts Eye and Ear Infirmary