Twice-daily brinzolamide/brimonidine fixed combination versus brinzolamide or brimonidine in open-angle glaucoma or ocular hypertension.

PURPOSE: To compare the intraocular pressure (IOP)-lowering efficacy and safety of brinzolamide 1% and brimonidine 0.2% fixed combination (BBFC) with that of brinzolamide 1% or brimonidine 0.2% monotherapy, all dosed 2 times per day (BID). DESIGN: Six-month, phase 3, randomized, multicenter, double-masked clinical trial. PARTICIPANTS: A total of 560 patients with primary open-angle glaucoma or ocular hypertension who had insufficient IOP reduction with their current therapeutic regimen or who were receiving ≥ 2 IOP-lowering medications. INTERVENTION: Patients received BBFC (n = 193), brinzolamide 1% (n = 192), or brimonidine 0.2% (n = 175) BID. MAIN OUTCOME MEASURES: The primary end point was mean change in diurnal IOP from baseline to month 3. Supportive end points included mean diurnal IOP change from baseline at week 2, week 6, and month 6; and mean IOP, mean IOP change from baseline, mean percentage IOP change from baseline, and percentage of patients with IOP <18 mmHg at week 2, week 6, month 3, and month 6 at each assessment time point (i.e., 9 am, 11 am, and 4 pm). Adverse events were recorded throughout the study. RESULTS: Baseline diurnal IOP was similar among groups (mean ± standard deviation: BBFC, 25.9 ± 0.19 mmHg; brinzolamide, 25.9 ± 0.20 mmHg; brimonidine, 26.0 ± 0.19 mmHg). At month 3, BBFC lowered mean diurnal IOP from baseline to a significantly greater extent than brinzolamide (least squares [LS] mean difference: -1.4 mmHg; P < 0.0001; t test) and brimonidine (LS mean difference: -1.5 mmHg; P < 0.0001). All supportive end points corroborated the results of the primary efficacy analysis. Mean percentage reductions in IOP from baseline were 26.7% to 36.0% with BBFC, 22.4% to 27.9% with brinzolamide, and 20.6% to 31.3% with brimonidine. The most common adverse drug reactions were ocular side effects, including hyperemia, blurred vision, allergic-type reactions, and discomfort. The incidence of hyperemia of the eye was slightly lower with brinzolamide than with BBFC and brimonidine, whereas blurred vision and ocular discomfort were slightly more common with BBFC than with brinzolamide or brimonidine. CONCLUSIONS: Brinzolamide 1% and brimonidine 0.2% fixed combination administered BID had a significantly greater IOP-lowering effect than either brinzolamide or brimonidine alone and displayed a safety profile consistent with its individual components.

Reduction in bacterial load using hypochlorous acid hygiene solution on ocular skin.

PURPOSE: To examine the magnitude of bacterial load reduction on the surface of the periocular skin 20 minutes after application of a saline hygiene solution containing 0.01% pure hypochlorous acid (HOCl). METHODS: Microbiological specimens were collected immediately prior to applying the hygiene solution and again 20 minutes later. Total microbial colonies were counted and each unique colony morphology was processed to identify the bacterial species and to determine the susceptibility profile to 15 selected antibiotics. RESULTS: Specimens were analyzed from the skin samples of 71 eyes from 36 patients. Prior to treatment, 194 unique bacterial isolates belonging to 33 different species were recovered. Twenty minutes after treatment, 138 unique bacterial isolates belonging to 26 different species were identified. Staphylococci accounted for 61% of all strains recovered and Staphylococcus epidermidis strains comprised 60% of the staphylococcal strains. No substantial differences in the distribution of Gram-positive, Gram-negative, or anaerobic species were noted before and after treatment. The quantitative data demonstrated a >99% reduction in the staphylococcal load on the surface of the skin 20 minutes following application of the hygiene solution. The total S. epidermidis colony-forming units were reduced by 99.5%. The HOCl hygiene solution removed staphylococcal isolates that were resistant to multiple antibiotics equally well as those isolates that were susceptible to antibiotics. CONCLUSION: The application of a saline hygiene solution preserved with pure HOCl acid reduced the bacterial load significantly without altering the diversity of bacterial species remaining on the skin under the lower eyelid.

Polyquaternium-1-Preserved Travoprost 0.003% or Benzalkonium Chloride-Preserved Travoprost 0.004% for Glaucoma and Ocular Hypertension.

PURPOSE: To demonstrate equivalence of polyquaternium-1-preserved travoprost 0.003% with benzalkonium chloride-preserved travoprost 0.004% in patients with open-angle glaucoma or ocular hypertension. DESIGN: Double-masked, randomized, 2-treatment, equivalence clinical trial. METHODS: setting: Multicenter clinical trial conducted in 60 centers in the United States and Europe. PATIENT POPULATION: Adult patients with open-angle glaucoma or ocular hypertension. One eye per patient was analyzed. INTERVENTION: Patients were randomized 1:1 to receive polyquaternium-1-preserved travoprost 0.003% (n = 442) or benzalkonium chloride-preserved travoprost 0.004% (n = 422) once daily for 3 months. MAIN OUTCOME MEASURES: Mean intraocular pressure (IOP) was assessed at 8 AM, 10 AM, and 4 PM at week 2, week 6, and month 3. Supportive outcomes were mean and percent IOP change, percentage of patients achieving IOP <18 mm Hg or ≥30% IOP reduction, and adverse events. RESULTS: Mean IOP was similar between groups at all study visits (travoprost 0.003% range, 17.5-18.9 mm Hg; travoprost 0.004% range, 17.4-19.0 mm Hg). Mean change (least squares mean differences, -0.1 to 0.3 mm Hg; 95% confidence interval, -0.5 to 0.7 mm Hg) and percentage change (travoprost 0.003%, 28.4%-30.7%; travoprost 0.004%, 28.5%-31.0%) from baseline were comparable. The percentages of patients with IOP <18 mm Hg and ≥30% reduction of IOP were also similar. Hyperemia was the most frequent treatment-related adverse event with both formulations (travoprost 0.003%, 11.8%; travoprost 0.004%, 14.5%). CONCLUSIONS: In patients with open-angle glaucoma or ocular hypertension, polyquaternium-1-preserved travoprost 0.003% solution provided equivalent IOP-lowering efficacy to that of benzalkonium chloride-preserved travoprost 0.004%.