Phase 4
N=15
Comparing Effects of Two Fixed Combinations Ophthalmic Solutions on Ocular Blood Flow
Glaucoma
Bottom Line
View on ClinicalTrials.gov: NCT00811850 ↗Enrolled (actual)
15
Serious AEs
0.0%
Results posted
Aug 2012
Primary outcome: Primary: Retrobulbar Blood Flow (Peak Systolic Velocity) as Measured by Color Doppler Imaging in the Nasal Short Posterior Ciliary Artery — 8.61; 8.02 Centimeters per second (cm/s)
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- fixed combination of brimonidine tartrate 0.2% timolol maleate 0.5% ophthalmic solution (Drug); fixed combination of dorzolamide hydrochloride timolol maleate ophthalmic solution (Drug)
- Age
- Adult, Older Adult · 30+ yrs
- Sex
- All
- Sponsor
- Allergan
- Primary completion
- Dec 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Retrobulbar Blood Flow (Peak Systolic Velocity) as Measured by Color Doppler Imaging in the Nasal Short Posterior Ciliary Artery |
8.61; 8.02 | — |
| PRIMARY Retrobulbar Blood Flow (End Diastolic Velocity) as Measured by Color Doppler Imaging in the Nasal Short Posterior Ciliary Artery |
2.63; 2.61 | — |
| PRIMARY Retrobulbar Blood Flow (Peak Systolic Velocity) as Measured by Color Doppler Imaging in the Temporal Short Posterior Ciliary Artery |
8.52; 8.84 | — |
| PRIMARY Retrobulbar Blood Flow (End Diastolic Velocity) as Measured by Color Doppler Imaging in the Temporal Short Posterior Ciliary Artery |
2.73; 2.87 | — |
| PRIMARY Retrobulbar Blood Flow (Peak Systolic Velocity) as Measured by Color Doppler Imaging in the Ophthalmic Artery |
24.5; 22.09 | — |
| PRIMARY Retrobulbar Blood Flow (End Diastolic Velocity) as Measured by Color Doppler Imaging in the Ophthalmic Artery |
5.83; 5.18 | — |
| PRIMARY Retrobulbar Blood Flow (Peak Systolic Velocity) as Measured by Color Doppler Imaging in the Central Retinal Artery |
8.86; 8.81 | — |
| PRIMARY Retrobulbar Blood Flow (End Diastolic Velocity) as Measured by Color Doppler Imaging in the Central Retinal Artery |
2.73; 2.75 | — |
Summary
A 10 week evaluation, crossover design study including a 3 week washout period between treatments, to determine the effects of Combigan® (fixed combination brimonidine tartrate 0.2%/timolol maleate 0.5%) and Cosopt® (fixed combination dorzolamide hydrochloride-timolol maleate ophthalmic solutions) on ocular blood flow as measured by retrobulbar blood flow.
Eligibility Criteria
Inclusion Criteria
- Age: 30 years or older.
- Primary open-angle glaucoma (POAG) or ocular hypertensive in at least one eye.
- Best corrected visual acuity at least 20/40 in at least one eye.
Exclusion Criteria
- History of acute angle-closure or a narrow, occludable anterior chamber angle by gonioscopy.
- History of chronic or recurrent inflammatory eye diseases (e.g., scleritis, uveitis).
- History or signs of intraocular trauma.
- Any abnormality preventing reliable applanation tonometry.
- Current use of any ophthalmic or systemic steroid which may interfere with this investigation.
- Severe, unstable or uncontrolled cardiovascular, renal, or pulmonary disease.
Data sourced from ClinicalTrials.gov (NCT00811850). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.