Fixed Combination Brinzolamide 1%/Timolol 0.5% Versus Brinzolamide 1% + Timolol 0.5% in Open-angle Glaucoma or Ocular Hypertension
| Status: | Completed |
|---|---|
| Conditions: | High Blood Pressure (Hypertension), Ocular |
| Therapuetic Areas: | Cardiology / Vascular Diseases, Ophthalmology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 11/18/2012 |
| Start Date: | December 2010 |
| End Date: | January 2013 |
| Contact: | Alcon Call Center |
| Email: | medical.information@alconlabs.com |
| Phone: | 1-888-451-3937 |
Eligible patients will be randomized in a 1.1 ratio to receive Brinzolamide 1%/Timolol 0.5%
or Brinzolamide 1% plus Timolol 0.5% two times a day for 8 Weeks. The study treatments will
be compared for mean diurnal intraocular pressure (IOP) change from baseline at Week 8.
Safety parameters measured at 4 study visits: ocular signs, visual acuity, cardiovascular
parameters (blood pressure and pulse), dilated fundus (entry and exit) and adverse events.
Inclusion Criteria:
- Patients of either sex and any race, 18 years of age or older, diagnosed with open
angle glaucoma or ocular hypertension who are not sufficiently responsive to
monotherapy.
- Patients must meet the following IOP criteria in at least one eye. For each
qualifying eye, the mean IOP should be ≥21 mmHg at 9 AM and 11 AM time points at the
eligibility visit
- The mean IOP in either eye at the eligibility visit must not be greater than 35 mmHg
at any time point.
Exclusion Criteria:
- Patients with any form of glaucoma other than open-angle glaucoma (with or without
pigment dispersion or pseudoexfoliation component) or ocular hypertension.
- Patients with iridocorneal angle Shaffer grade less than 2 (extreme narrow angle with
complete or partial closure) in either eye, as measured by gonioscopy.
- Patients with cup/disc ratio greater than 0.8 in either eye.
- Patients with severe central visual field loss in either eye. Severe central field
loss is defined as a sensitivity of ≤ 10dB in at least 2 of the 4 visual field test
points closest to the point of fixation.
- History of chronic, recurrent, or severe ocular infection, inflammatory eye disease
(e.g., scleritis, uveitis, herpes keratitis) in either eye.
- Current ocular infection or ocular inflammation within the past 3 months in either
eye.
- History of, or current clinically relevant or progressive retinal disease such as
retinal degeneration, diabetic retinopathy, or retinal detachment in either eye.
- History of, or current other severe ocular pathology (including severe dry eye) in
either eye, that would preclude the administration of a topical CAI or beta-blocker.
- History of ocular trauma within the past 6 months in either eye.
- Intraocular surgery within the past 3 months.
- Ocular laser surgery within the past 3 months.
- Best-corrected visual acuity score worse than 55 ETDRS letters read (equivalent to
approximately 20/80 Snellen, 0.60 logMAR or 0.25 decimal).
- Any abnormality preventing reliable applanation tonometry.
We found this trial at
1
site
Alcon Call Center Alcon is helping people see the world better through advanced surgical, pharmaceutical...
Click here to add this to my saved trials
