Efficacy and Toxicity Evaluation of Bepotastine Besilate 1.5% Preservative-Free Eye Drops Vs Olopatadine Hydrochloride 0.2% Bak-Preserved Eye Drops in Patients with Allergic Conjunctivitis.

Purpose: To study the efficacy and toxic effects of bepotastine besilate 1.5% preservative-free (BB-PF) and olopatadine 0.2% BAK-preserved (OL-BAK) drops on the ocular surface of patients with allergic conjunctivitis. Patients and Methods: Ninety-seven patients with allergic conjunctivitis diagnosis participated in a prospective, multicenter, randomized, double-blind, controlled, parallel-group clinical trial. Patients received either BB-PF (n=48) or OL-BAK (n=49), both administered once daily in the morning. The patients were followed for 60 days. Ocular itching was the primary outcome measure. Secondary outcomes included ocular symptoms, signs, and non-ocular symptoms associated with rhinoconjunctivitis. Conjunctival impression cytology (CIC) was performed to evaluate histopathological changes related to the toxic effects of preservatives. Results: BB-PF treatment was associated with a 1.30 more probability of diminished ocular itching than OL-BAK (odds ratio (OR)=1.30; 95% CI=(0.96-1.7); p=0.086). No statistically significant differences were found between treatments in the resolution of other ocular symptoms or signs, except for tearing, which was superior in the BB-PF (OR=1.37; 95% (1.26-1.47); p<0.0001). BB-PF was superior in terms of the resolution of rhinorrhea (p=0.040) and nasal itching (p=0.037). After 60 days of treatment, the BB-PF group exhibited 2.0 times higher probability of having a lower Nelson scale score compared to the OL-BAK group (OR=2.00; 95% CI=(1.19-3.34); p=0.010). Conclusion: Both medications presented a similar efficacy in terms of the resolution of ocular signs and symptoms associated with ocular conjunctivitis. BB-PF is superior in the resolution of non-ocular symptoms and safer for the ocular surface than OL-BAK.

Management Of Glaucoma In Developing Countries: Challenges And Opportunities For Improvement.

Glaucoma is the leading cause of blindness in the developed and developing world. Not only is the clinical impact of this disease considerable, but associated economic and humanistic burdens - affecting patients, caregivers, and society - are substantial. Since glaucoma is an age-related disorder and populations in many developing countries are aging at a faster pace than in the developed world, increasing attention is being focused on ways to ameliorate the burdens of illness. In this paper, we examine the burdens of glaucoma with particular focus on developing countries, discuss some of the challenges that exist in delivering optimal glaucoma management within budget constraints, and bring into perspective how we could improve current healthcare systems, leverage technology, and strike an appropriate balance between cost and quality of care, thereby offering considerations to payors and policymakers in these countries that may result in longer-term cost savings, while concurrently striving to achieve the WHO Vision on the prevention of blindness and visual impairment.

Ocular Surface Evaluation After the Substitution of Benzalkonium Chloride Preserved Prostaglandin Eye Drops by a Preservative-free Prostaglandin Analogue.

To evaluate ocular surface changes after withdrawal of Benzalkonium chloride (BAK) in patients with glaucoma in monotherapy with BAK-preserved prostaglandin. This was a prospective observational study. All patients underwent complete ophthalmologic examination and evaluation of ocular surface. A questionnaire was filled regarding symptoms of dry eye (Ocular Surface Disease Index [OSDI]) at the beginning of study. The treatment was switched to preservative-free tafluprost for 6 weeks and after this period, all patients were re-evaluated. All patients reported improvement of symptoms. The green lissamine test showed a significant improvement of the ocular surface, with most patients classified as light dry eye (P < 0.001). A significant improvement in the score (P < 0.001) was also found, with an average of 17.95 ± 5.35 points, which classifies the patients' symptoms in the normal to light zone. Benzalkonium chloride withdrawal reduced the signs and symptoms of dry eye in patients with primary open angle glaucoma (POAG).

Stability, sensory attributes and acceptance of panettones elaborated with Lactobacillus fermentum IAL 4541 and Wickerhamomyces anomallus IAL 4533.

This work aimed to elaborate sourdough panettones with Lactobacillus fermentum (LF) and Wickerhamomyces anomallus (WA) evaluating their microbiological stability, physical and chemical characteristics as well as the impact of these microorganisms on sensory aspects and consumer acceptance. For characterization, panettones were elaborated by long fermentation, using two selected microorganisms, LF and WA in different proportions; and control panettones were formulated using commercial yeast with and without preservative. For sensory analyses, LF, WA, LF/WA (1:1), control with calcium propionate and commercial panettones were compared. Regarding the pH values and total titratable acidity (TTA), a similar behavior was observed among panettones elaborated with the selected strains (LF, WA and mixtures). On the other hand, panettones elaborated with commercial yeast showed a higher pH and lower TTA. Until the 112nd day of storage, the water activity (aw) was similar among all panettones, but in the following analyses, it dropped in all panettones. Panettones elaborated with sourdough maintained better their softness during the storage, when compared with the controls. Regarding microbial stability, control panettones with and without preservative became moldy faster; while sourdough panettones (WA and LF/WA) remained stable throughout all the monitored storage. Sensory evaluation by CATA allowed distinguishing between sourdough and commercial yeast panettones. Desirable characteristics such as nice aroma, pleasant taste and uniform color were checked more often for LF and WA elaborated panettones, whereas yeast flavor was checked more often for the Commercial. Moreover, according to the descriptors used, panettones were grouped into 3 groups: LF/WA, LF + WA and controls. The panettones elaborated with the specific microorganisms of this study were well-accepted sensorially, proving to be very competitive with respect to control and commercial panettone. So, the use of selected microorganisms as a starter for sourdough is a promising alternative for producing panettones with good technological quality, microbiological stability, sensorially differentiate and well accepted by consumers; and, additionally, with the appeal of no added preservative.

Real-life results of switching from preserved to preservative-free artificial tears containing hyaluronate in patients with dry eye disease.

BACKGROUND: Dry eye disease (DED) is a chronic, multifactorial disease of the ocular surface leading to discomfort, visual disturbance, and tear film instability, with potential damage to the ocular surface. AIM: The aim of this study was to assess the clinical benefit of a switch from preserved to preservative-free artificial tears (ATs) containing hyaluronate in patients with DED. MATERIALS AND METHODS: This is a nationwide, multicenter, noninterventional, and transversal observational survey. RESULTS: The mean age was 51.0±15.4 years, ranging from 6 to 96 years. The majority (61.4%) was female. The mean Ocular Surface Disease Index (OSDI) before the switch was surprisingly high at 56.0±23.5, and 73.0% of the patients had superficial punctate keratitis (SPK). The mean duration of use of preserved ATs before the switch was 15.8±12.1 months. OSDI scores and the presence of SPK correlated with the patients' ages but were independent of the duration of treatment with the preserved AT. The patients using ATs containing "soft" or "vanishing" preservatives presented exactly the same clinical pattern (level of OSDI and frequency of SPK) as those using ATs containing classical preservatives such as benzalkonium chloride (BAK). After switching to preservative-free AT containing hyaluronate (Hyabak®), the OSDI of 97.0% of the patients improved, decreasing from an average of 56.0 to an average of 28.2, with 23% of patients reporting a normal value of OSDI. The SPK frequency as well improved dramatically, with a frequency of positive fluorescein staining dropping from 73% to 46.1% of patients. A total of 94.0% of the patients considered that they preferred being treated with the preservative-free AT. CONCLUSION: In patients suffering from DED and treated with a preserved AT, switching to a preservative-free AT provides clinical benefit by decreasing the severity of DED and reducing the prevalence of SPK, even after only 3 weeks of daily use of the preservative-free AT.

A Phase III Randomized Clinical Trial of a 0.5% Timolol + 0.2% Brimonidine + 2.0% Dorzolamide Fixed Combination, Preservative-Free Ophthalmic Solution vs. 0.5% Timolol + 0.2% Brimonidine + 2.0% Dorzolamide Fixed Combination in Patients with Controlled Primary Open-Angle Glaucoma.

INTRODUCTION: The aim of this prospective crossover study was to evaluate the non-inferiority of PRO-122 (a preservative-free fixed combination) compared with 0.5% timolol + 0.2% brimonidine + 2.0% dorzolamide fixed combination (KOF) by evaluating its efficacy, tolerability and safety in subjects with controlled primary open-angle glaucoma (POAG) previously treated with KOF for at least 2 months. METHODS: In a prospective, crossover, randomized, double-masked multicenter study, patients previously treated with KOF were randomly assigned to receive either PRO-122 or KOF for 30 days. On day 31, the A sequence changed to KOF, while the B sequence received PRO-122. All patients remained in the protocol for 30 additional days for a total of 60 days. The main efficacy endpoint was maintaining the controlled intraocular pressure (IOP). The safety and tolerability of both products were assessed by the presence of adverse events (AEs), ocular findings, a questionnaire on ocular comfort and the VF-14 index. RESULTS: A total of 51 patients participated. After application of PRO-122 twice a day, its efficacy was demonstrated through maintenance of the controlled IOP in patients previously controlled with KOF. The crossover between PRO-122 and KOF and vice versa, after 30 days of use, did not affect IOP control. PRO-122 was shown not to be inferior to KOF in maintaining IOP at control levels. The safety of both drugs is similar, as neither presented drug-related AEs or differences regarding safety issues. The tolerability of the two medications-evaluated by ocular findings, the questionnaire on ocular comfort and the VF-14 index-was also determined to be similar. CONCLUSIONS: The controlled IOP in patients with controlled POAG treated with PRO-122 was maintained both in relation to the initial controlled IOP of the study and when compared with KOF in the B sequence. Finally, the treatment with PRO-122 demonstrated similar safety and tolerability to KOF. FUNDING: Laboratorios Sophia, S.A. de C.V. (Zapopan, Jalisco, México). TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT03257813 (registered retrospectively).