ABSTRACT: To compare the efficacy of brinzolamide versus placebo when added to travoprost/timolol fixed combination (TTFC) in uncontrolled patients.
This was a prospective, double-masked, randomized, placebo-controlled, parallel comparison of ocular hypertensive or primary open-angle glaucoma patients. Patients treated with a prostaglandin-based mono or adjunctive therapy were changed to TTFC qam (every day dosing) for 4 weeks. Patients with an intraocular pressure (IOP) of 19 to 32 mm Hg at 08:00 hours underwent additional measurements at 12:00 and 16:00 hours. Patients were then randomized to either placebo or brinzolamide given twice daily in addition to TTFC. At week 12, patients had their IOP measurements repeated.
The per protocol dataset consisting of 78 placebo and 75 brinzolamide-treated patients decreased mean diurnal IOP (mm Hg) as well as IOP at all 3 individual time points (P≤0.005). Brinzolamide reduced the mean diurnal IOP from 20.3±2.0 to 17.5±2.6, whereas placebo reduced IOP from 20.9±2.7 to 19.4±3.8. The mean diurnal IOP was reduced from baseline and for the 08:00 and 16:00 hours time points in the brinzolamide group compared with placebo (P≤0.014). There were 30 adverse events with placebo and 24 with brinzolamide (intent-to-treat). There was no statistical difference for the side-effect profile observed between the treatment groups (P=0.47).
This study suggests that brinzolamide may be safely added to TTFC therapy to provide further significant reduction in IOP patients with ocular hypertensive or primary open-angle glaucoma.
Journal of glaucoma 11/2010; 21(1):55-9. · 1.74 Impact Factor
ABSTRACT: To determine the prevalence of ocular surface disease (OSD) in patients with glaucoma using topical intraocular pressure (IOP)-lowering therapy.
This prospective observational study enrolled patients with primary open-angle glaucoma or ocular hypertension who were on a topical IOP-lowering medication regimen. Enrolled patients completed the ocular surface disease index (OSDI) and OSDI scores (0-100, with 0 representing no symptoms) were calculated for each patient. Medical history, demographics, and concomitant medication information were also collected.
Overall, 630 patients from 10 sites participated. Of these, 305 patients (48.4%) had an OSDI score indicating either mild (n = 134, 21.3%), moderate (n = 84, 13.3%), or severe (n = 87, 13.8%) OSD symptoms. OSDI scores were significantly different between patients with and without a prior diagnosis of dry eye syndrome (25.2 +/- 15.4 vs 15.4 +/- 15.8, respectively; P = 0.0036) and between patients who did and did not use artificial tears at the time of study participation (23.0 +/- 15.6 vs 15.3 +/- 15.8, respectively; P = 0.0046). Mean OSDI scores varied significantly with the number of topical IOP-lowering medications used, with higher (more severe) OSDI scores in patients using multiple IOP-lowering medications. Specifically, patients on a single medication had a mean OSDI score of 12.9 +/- 13.1, which was significantly lower than those of patients on 2 (16.7 +/- 17.0; P = 0.007) or 3 medications (19.4 +/- 18.1; P = 0.0001).
OSD is prevalent among medically treated patients with glaucoma. The severity of OSD symptoms is positively correlated to the number of IOP-lowering medications used.
Cornea 04/2010; 29(6):618-21. · 1.73 Impact Factor
ABSTRACT: To assess the safety and efficacy of changing to the travoprost/timolol fixed combination (TTFC) from other mono- or adjunctive therapies.
A prospective, open-label, observational cohort of primary open-angle glaucoma and ocular hypertensive patients whose intraocular pressure (IOP) was uncontrolled on prior therapy or was not on target. Patients were changed from prior mono- or adjunctive treatment at Day 0 to TTFC dosed every evening and underwent active treatment efficacy and safety evaluations at Week 12.
In 474/522 (91%) patients who completed this trial an IOP (mm Hg) of 21.9 +/- 2.0 on prior treatment was reduced by TTFC at Month 3: from all prior treatments 5.6 +/- 2.6; from monotherapy 5.9 +/- 2.3; from adjunctive treatments 4.5 +/- 2.9; and from several of the most frequent individual treatments: timolol 5.7 +/- 2.2; latanoprost 6.3 +/- 2.6; and latanoprost/timolol fixed combination 4.4 +/- 1.9. Ocular hyperemia was the most frequent adverse effect (n = 21, 4%). Both patients and physicians preferred TTFC compared to all prior and common individual treatments. The solicited symptom survey showed, following a modified Bonferroni correction (alpha/5), a reduced incidence with TTFC of ocular pain (P = 0.01) while the prior medicine had a lower incidence of burning on instillation (P < 0.001).
Changing patients from prior mono- or adjunctive therapy to TTFC can provide on average a further reduction in IOP while demonstrating a favorable safety profile and a high patient preference.
Clinical Ophthalmology 01/2010; 4:459-66.
ABSTRACT: The purpose of this study was to compare the aqueous humor concentrations of bimatoprost acid after topical instillation in rabbits of bimatoprost ophthalmic solution 0.01% and bimatoprost ophthalmic solution 0.03%, two commercially available intraocular pressure-lowering medications.
Male Dutch Belted rabbits were divided into two teratment groups (four rabbits/eight eyes per group): bimatoprost 0.01% and bimatoprost 0.03%. Thirty microliters (μL) of study medication was to pically instilled into both eyes of each animal. Thirty minutes and 90 minutes after instillation, aqueous humor samples were collected. These samples were analyzed by reverse-phase high-performance liquid chromatography for bimatoprost acid concentration.
Following a single topical ocular instillation, the bimatoprost 0.01% formulation had a lower mean aqueous humor concentration of bimatoprost acid than the bimatoprost 0.03% formulation at both 30 minutes (11.5 ± 2.1 ng/mL versus 37.8 ± 28.8 ng/mL; P = 0.17) and 90 minutes (20.8 ± 5.7 ng/mL versus 45.8 ± 14.3 ng/mL; P = 0.03) after topical instillation.
Topical ocular instillation of bimatoprost 0.01% produced significantly lower bimatoprost acid concentration in the aqueous humor of rabbits than bimatoprost 0.03%, despite the 4-fold increase of benzalkonium chloride contained in bimatoprost 0.01%.
Clinical Ophthalmology 01/2010; 4:1447-50.
ABSTRACT: To compare the diurnal intraocular pressure (IOP)-lowering efficacy and safety of travoprost 0.004% and tafluprost 0.0015% administered to patients with primary open-angle glaucoma or ocular hypertension.
This was a randomized, double-masked, active-controlled, crossover design trial, in which patients were randomized to either travoprost or tafluprost monotherapy administered once daily in the evening for six weeks and then crossed over to the alternative treatment for another six weeks. Diurnal IOP was measured (8 am to 8 pm, every two hours) and a solicited symptom survey was administered at the end of both six-week periods, as was conjunctival hyperemia and visual acuity assessment, slit-lamp biomicroscopy, and adverse event solicitation.
Fifty-one patients were randomized and 48 patients completed the study. The 12-hour mean diurnal IOP was significantly lower with travoprost therapy than with tafluprost therapy (P = 0.01), and a significantly lower IOP was also reported for travoprost at five of the seven individual time points (P < 0.05). Neither therapy produced a significant increase from baseline in any of the individual patient-reported symptom scores, except for hyperemia (P ≤ 0.01), which was increased with both treatments. Investigator-observed hyperemia was also increased from baseline with both therapies (P < 0.01), although the increase with travoprost therapy was significantly smaller than with tafluprost (P < 0.01). No additional safety concerns were noted from slit-lamp biomicroscopy or visual acuity results, and no difference was noted in patient-reported tolerability of the two medications.
Travoprost 0.004% monotherapy produced lower diurnal IOP than tafluprost 0.0015% in patients with primary open-angle glaucoma or ocular hypertension and exhibited a similar safety profile.
Clinical Ophthalmology 01/2010; 4:1459-63.