The Diurnal and Nocturnal Effect of Simbrinza and Timolol on Intraocular Pressure and Ocular Perfusion Pressure
| Status: | Completed |
|---|---|
| Conditions: | High Blood Pressure (Hypertension), Ocular |
| Therapuetic Areas: | Cardiology / Vascular Diseases, Ophthalmology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | August 2014 |
| End Date: | March 2016 |
The purpose of this research study is to hypothesize that Simbrinza will achieve a decrease
in intraocular pressure and increase in ocular perfusion pressure throughout the diurnal and
nocturnal periods. The primary aim of this study will be to determine the effects of
Simbrinza at multiple intervals throughout a 24-hour period. The secondary aim will be to
compare these to those of timolol.
in intraocular pressure and increase in ocular perfusion pressure throughout the diurnal and
nocturnal periods. The primary aim of this study will be to determine the effects of
Simbrinza at multiple intervals throughout a 24-hour period. The secondary aim will be to
compare these to those of timolol.
Intraocular pressure (IOP) is a major risk factor for the development of glaucoma. In
addition, it is the only modifiable factor in the prevention and subsequent treatment of
glaucomatous optic neuropathy. Most clinicians only have access to a single IOP measurement
during a patient visit that may only occur once every four months. These snapshots in time
are probably not adequate for the optimal management of glaucoma. Diurnal IOP curves can
provide a better estimate of each patient's individual IOP variation throughout the day.
However diurnal curves do not typically cover another crucial time, the nocturnal period.
Glaucomatous eyes have been shown to have different IOP curves during the nocturnal period
compared to healthy controls. In addition, different classes of glaucoma drugs have variable
IOP lowering effects during the nocturnal hours compared to the diurnal/wake period. For
example, the betablocker timolol was shown to lower IOP during daytime hours but failed to
lower IOP during the nocturnal period in the habitual position. Similarly, the alpha-agonist
brimonidine failed to lower IOP overnight after significantly lowering IOP during the
diurnal period. On the other hand, the prostaglandin analogues, including latanoprost and
travoprost, lowered IOP throughout the diurnal and nocturnal periods although nocturnal
lowering appears less than the daytime hours. Therefore it is crucial to determine an
accurate IOP curve for each form of medication during both wake and sleep hours.
addition, it is the only modifiable factor in the prevention and subsequent treatment of
glaucomatous optic neuropathy. Most clinicians only have access to a single IOP measurement
during a patient visit that may only occur once every four months. These snapshots in time
are probably not adequate for the optimal management of glaucoma. Diurnal IOP curves can
provide a better estimate of each patient's individual IOP variation throughout the day.
However diurnal curves do not typically cover another crucial time, the nocturnal period.
Glaucomatous eyes have been shown to have different IOP curves during the nocturnal period
compared to healthy controls. In addition, different classes of glaucoma drugs have variable
IOP lowering effects during the nocturnal hours compared to the diurnal/wake period. For
example, the betablocker timolol was shown to lower IOP during daytime hours but failed to
lower IOP during the nocturnal period in the habitual position. Similarly, the alpha-agonist
brimonidine failed to lower IOP overnight after significantly lowering IOP during the
diurnal period. On the other hand, the prostaglandin analogues, including latanoprost and
travoprost, lowered IOP throughout the diurnal and nocturnal periods although nocturnal
lowering appears less than the daytime hours. Therefore it is crucial to determine an
accurate IOP curve for each form of medication during both wake and sleep hours.
Inclusion Criteria:
- Diagnosis of open angle glaucoma or ocular hypertension including pigment dispersion
glaucoma and pseudoexfoliation glaucoma.
- Age ≥ 18 years, of either gender, or any race/ethnicity
Exclusion Criteria:
- Females who are currently pregnant or planning to become pregnant during the study
period
- Contraindications to beta blockers (see below)
- Patients currently taking oral beta blocker therapy
- Diagnosis of any other form of glaucoma other than open-angle
- Schaffer angle grade < 2 in either eye by gonioscopy
- Intraocular surgery within 6 months or laser within 3 months
- Inability to safely discontinue all ocular medications for 6 weeks
- Patients who smoke or have irregular daily sleep patterns
- History of allergy or intolerance to topical carbonic anhydrase inhibitors, or
alpha-agonists
- Patients who have started or changed glucocorticoids therapy in the last 3 months
- Patients who are currently using medical or recreational marijuana
- Any use of a non-FDA approved medication for glaucoma in the last 3 months
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