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The British Journal of Ophthalmology Sep 2007Using triamcinolone acetonide without preservative may improve safety
Using triamcinolone acetonide without preservative may improve safety
Topics: Endophthalmitis; Eye Diseases; Glucocorticoids; Humans; Ophthalmic Solutions; Preservatives, Pharmaceutical; Triamcinolone Acetonide
PubMed: 17709575
DOI: 10.1136/bjo.2007.117432 -
Acta Ophthalmologica Nov 2008Antiglaucoma medications are often associated with ocular adverse reactions such as dry eye, and burning or stinging sensations. These undesirable effects may lead to... (Review)
Review
Antiglaucoma medications are often associated with ocular adverse reactions such as dry eye, and burning or stinging sensations. These undesirable effects may lead to treatment discontinuation and reduced quality of life in patients with glaucoma. Antiglaucoma medications usually contain benzalkonium chloride (BAK) as a preservative. Animal studies, in vitro studies and in vivo experiments have demonstrated various adverse effects of BAK. Clinical studies have also shown an increased incidence of adverse events with BAK and have demonstrated that the withdrawal of preservatives reduces these effects. Collectively, these data suggest that preservative-free antiglaucoma treatments have clinically relevant benefits for patients.
Topics: Animals; Benzalkonium Compounds; Eye; Glaucoma; Humans; Ophthalmic Solutions; Patient Compliance; Preservatives, Pharmaceutical; Quality of Life
PubMed: 18537937
DOI: 10.1111/j.1755-3768.2008.01250.x -
Comparison of the efficacy of preservative free ipratropium bromide and Atrovent nebuliser solution.Thorax Jun 1988The paradoxical bronchoconstriction observed with commercially available isotonic ipratropium bromide nebuliser solution (Atrovent) in patients with asthma results from... (Clinical Trial)
Clinical Trial Comparative Study
The paradoxical bronchoconstriction observed with commercially available isotonic ipratropium bromide nebuliser solution (Atrovent) in patients with asthma results from an adverse reaction to the preservatives, benzalkonium chloride and ethylenediaminetetra-acetic acid (EDTA). The airway response to inhaled Atrovent and preservative free ipratropium bromide nebuliser solutions has been examined in a double blind study. On separate occasions 30 asthmatic subjects inhaled 2 ml of the solutions and airway calibre was measured in terms of FEV1 for 45 minutes. Atrovent nebuliser solution provoked a greater than 20% fall in FEV1 in five of the 30 subjects, whereas this did not occur after preservative free ipratropium bromide. Inhalation of the preservative free solution resulted in more rapid and greater overall bronchodilatation than Atrovent, with mean maximum increases in FEV1 of 29.2% and 18.5% respectively. It is concluded that the risk of paradoxical bronchoconstriction with ipratropium bromide is considerably reduced by removal of benzalkonium chloride and EDTA and that preservative free ipratropium bromide is a more potent bronchodilator than the currently available Atrovent solution.
Topics: Airway Resistance; Asthma; Atropine Derivatives; Benzalkonium Compounds; Double-Blind Method; Edetic Acid; Female; Forced Expiratory Volume; Humans; Ipratropium; Male; Middle Aged; Nebulizers and Vaporizers; Pharmaceutic Aids; Preservatives, Pharmaceutical
PubMed: 2971274
DOI: 10.1136/thx.43.6.446 -
Molecules (Basel, Switzerland) Jun 2023Stilbene and its derivatives belong to the group of biologically active compounds. Some derivatives occur naturally in various plant species, while others are obtained... (Review)
Review
Stilbene and its derivatives belong to the group of biologically active compounds. Some derivatives occur naturally in various plant species, while others are obtained by synthesis. Resveratrol is one of the best-known stilbene derivatives. Many stilbene derivatives exhibit antimicrobial, antifungal or anticancer properties. A thorough understanding of the properties of this group of biologically active compounds, and the development of their analytics from various matrices, will allow for a wider range of applications. This information is particularly important in the era of increasing incidence of various diseases hitherto unknown, including COVID-19, which is still present in our population. The purpose of this study was to summarize information on the qualitative and quantitative analysis of stilbene derivatives, their biological activity, potential applications as preservatives, antiseptics and disinfectants, and stability analysis in various matrices. Optimal conditions for the analysis of the stilbene derivatives in question were developed using the isotachophoresis technique.
Topics: Humans; Stilbenes; COVID-19; Resveratrol; Antifungal Agents; Preservatives, Pharmaceutical
PubMed: 37298957
DOI: 10.3390/molecules28114482 -
Journal of Investigational Allergology... Jun 2024Bilastine is a second-generation antihistamine approved for the symptomatic treatment of allergic rhinoconjunctivitis and urticaria. The present trial evaluated the... (Randomized Controlled Trial)
Randomized Controlled Trial
BACKGROUND AND OBJECTIVE
Bilastine is a second-generation antihistamine approved for the symptomatic treatment of allergic rhinoconjunctivitis and urticaria. The present trial evaluated the efficacy and safety of a new bilastine 0.6% preservative-free eye drop formulation for the symptomatic treatment of allergic conjunctivitis.
METHODS
This phase 3, multicenter, double-masked, randomized study compared the efficacy, safety, and tolerability profile of bilastine 0.6% ophthalmic solution with that of ketotifen 0.025% and vehicle. The primary efficacy endpoint was reduction in ocular itching. The Ora-CAC® Allergen Challenge Model was used to assess ocular and nasal symptoms at 15 minutes (onset of action) and 16 hours after treatment.
RESULTS
Patients (N=228) were 59.6% male, and the mean (SD) age was 44.1 (13.4) years. Bilastine demonstrated efficacy in reducing ocular itching compared to vehicle at both onset of action and 16 hours after treatment (P<.001). Symptoms improved with ketotifen compared to vehicle 15 minutes after treatment (P<.001). Bilastine demonstrated statistical noninferiority to ketotifen for all 3 post-CAC timepoints at 15 minutes after instillation, based on an inferiority margin of 0.4. Compared with vehicle, bilastine improved in conjunctival redness, ciliary redness, episcleral redness, chemosis, eyelid swelling, tearing, rhinorrhea, ear and palate pruritus, and nasal congestion at 15 minutes after treatment (P<.05). Ophthalmic bilastine was safe and well tolerated. Mean drop comfort scores were significantly better for bilastine than for ketotifen immediately upon instillation (P<.05) and similar to those of vehicle.
CONCLUSION
Ophthalmic bilastine effectively reduced ocular itching for 16 hours after administration, suggesting that it could be used as a once-daily treatment for the signs and symptoms of allergic conjunctivitis. ClinicalTrials.gov identifier: NCT03479307.
Topics: Humans; Conjunctivitis, Allergic; Male; Ophthalmic Solutions; Female; Adult; Middle Aged; Piperidines; Benzimidazoles; Double-Blind Method; Treatment Outcome; Preservatives, Pharmaceutical; Ketotifen; Young Adult
PubMed: 36811846
DOI: 10.18176/jiaci.0894 -
Journal of Applied Microbiology Aug 1997Plasmid-encoded bacterial resistance to antibiotics and to anions and cation (including important mercurial and silver compounds) has been widely studied.... (Review)
Review
Plasmid-encoded bacterial resistance to antibiotics and to anions and cation (including important mercurial and silver compounds) has been widely studied. Plasmid-mediated resistance to organic cationic agents which are important biocides has been described for chlorhexidine and quaternary ammonium compounds (and also for the less important acridine, diamidines and ethidium bromide) in antibiotic-resistant Staphylococcus aureus and Staph. epidermidis strains. Plasmids may also encode reduced biocide susceptibility of Gram-negative bacteria, but intrinsic resistance is likely to be of greater significance. Antibiotic resistance and biocide resistance may be linked but this is not always found clinically.
Topics: Anti-Infective Agents, Local; Disinfectants; Drug Resistance, Microbial; Gram-Negative Bacteria; Plasmids; Preservatives, Pharmaceutical; Staphylococcus aureus; Staphylococcus epidermidis
PubMed: 9281819
DOI: 10.1046/j.1365-2672.1997.00198.x -
Chemical & Pharmaceutical Bulletin 2023Benzalkonium chloride (BAC) is a useful preservative for ophthalmic solutions but has some disadvantageous effects on corneal epithelium, especially keratinocytes....
Benzalkonium chloride (BAC) is a useful preservative for ophthalmic solutions but has some disadvantageous effects on corneal epithelium, especially keratinocytes. Therefore, patients requiring the chronic administration of ophthalmic solutions may suffer from damage due to BAC, and ophthalmic solutions with a new preservative instead of BAC are desired. To resolve the above situation, we focused on 1,3-didecyl-2-methyl imidazolium chloride (DiMI). As a preservative for ophthalmic solutions, we evaluated the physical and chemical properties (absorption to a sterile filter, solubility, heat stress stability, and light/UV stress stability), and also the anti-microbial activity. The results indicated that DiMI was soluble enough to prepare ophthalmic solutions, and was stable under severe heat and light/UV conditions. In addition, the anti-microbial effect of DiMI as a preservative was considered to be stronger than BAC. Moreover, our in vitro toxicity tests suggested that DiMI is safer to humans than BAC. Considering the test results, DiMI may be an excellent candidate for a new preservative to replace BAC. If we can overcome manufacturing process issues (soluble time and flushing volume) and the insufficiency of toxicological information, DiMI may be widely adopted as a safe preservative, and immediately contribute to the increased well-being of all patients.
Topics: Humans; Benzalkonium Compounds; Ophthalmic Solutions; Preservatives, Pharmaceutical; Epithelium, Corneal
PubMed: 37394604
DOI: 10.1248/cpb.c23-00115 -
The British Journal of Ophthalmology Apr 2002To determine the incidence of ocular toxicity of preservatives with glaucoma medications.
AIM
To determine the incidence of ocular toxicity of preservatives with glaucoma medications.
METHODS
A prospective epidemiological survey was carried out in 1999 by 249 ophthalmologists on 4107 patients. Ocular symptoms, conjunctiva, cornea, and eyelids were assessed. A chi(2) test was used for differences between preserved eye drops (P) and preservative free eye drops (PF).
RESULTS
84% patients used P, 13% received PF, and 3% a combination of P and PF eye drops. All symptoms were more prevalent with P than with PF drops (p<0.001): discomfort upon instillation (43% versus 17%), and symptoms between instillations such as burning-stinging (40% versus 22%), foreign body sensation (31% versus 14%), dry eye sensation (23% versus 14%), tearing (21% versus 14%), and eyelid itching (18% versus 10%). An increased incidence (>2 times) of ocular signs was seen with P eye drops. The prevalence of signs and symptoms was dose dependent, increasing with the number of P drops. A reduction in the symptoms and signs was observed when patients changed from P to PF eye drops (p<0.001).
CONCLUSIONS
Symptoms and signs are less prevalent when PF drops are used. Moreover, most of the adverse reactions induced by P glaucoma medication are reversible after removing preservatives.
Topics: Adolescent; Adult; Aged; Aged, 80 and over; Child; Child, Preschool; Cross-Sectional Studies; Eye Diseases; Female; France; Glaucoma; Humans; Male; Middle Aged; Ophthalmic Solutions; Preservatives, Pharmaceutical; Prevalence; Prospective Studies
PubMed: 11914211
DOI: 10.1136/bjo.86.4.418 -
Journal of Ocular Pharmacology and... May 2023Prostaglandin analogue topical medications are one of the most effective therapeutic approaches for the chronic management of glaucoma and ocular hypertension, through... (Review)
Review
Prostaglandin analogue topical medications are one of the most effective therapeutic approaches for the chronic management of glaucoma and ocular hypertension, through the reduction of elevated intra ocular pressure (IOP). While many of the first generations of anti-glaucoma eye drops were preserved with benzalkonium chloride, their repeated use may induce chronic ocular surface toxicity that leads to ocular surface disease (OSD) signs and symptoms. As a result, soft-preservatives and preservative-free formulations have been developed with the goal to avoid the long-term iatrogenic toxicity of the preservative agents. In addition, it has been suggested that OSD and its associated inflammation may negatively impact the efficacy of the IOP-lowering medications, including treatment adherence and compliance. Hence, it may be particularly interesting that glaucoma medications can concomitantly protect and "heal" the ocular surface and its environment while lowering elevated IOP, for the greater benefit of glaucoma patients. The objective of the present review is to briefly present the preclinical data of the cationic oil-in-water emulsion of latanoprost (latanoprost-CE) to shed some light on its mechanisms of action. It overall supports the following hypothesis: the restoration of a healthy ocular surface environment and treatment of the OSD signs and symptoms will allow for an improved elevated IOP reduction and glaucoma management. This would be achieved with a once daily dosing regimen to preserve glaucoma patients' vision, ocular surface, and quality-of-life and wellness.
Topics: Humans; Latanoprost; Glaucoma, Open-Angle; Emulsions; Intraocular Pressure; Prostaglandins F, Synthetic; Antihypertensive Agents; Glaucoma; Ocular Hypertension; Ophthalmic Solutions; Preservatives, Pharmaceutical
PubMed: 37015075
DOI: 10.1089/jop.2022.0155 -
Acta Ophthalmologica Aug 2014To evaluate the intra-operative and postoperative outcome of paediatric cataract surgery with primary posterior capsulotomy (PPC) and anterior vitrectomy using... (Comparative Study)
Comparative Study Randomized Controlled Trial
PURPOSE
To evaluate the intra-operative and postoperative outcome of paediatric cataract surgery with primary posterior capsulotomy (PPC) and anterior vitrectomy using intra-operative preservative-free triamcinolone acetonide.
METHODS
In this prospective, interventional case-control study, 20 Children who underwent cataract surgery for both eyes were enrolled and their eyes were randomized into two groups. Group A consists of 20 eyes in which standard phacoaspiration with PPC with intracameral triamcinolone was used, and Group B consists of 20 eyes in which triamcinolone were not used. Intra-operative complications and postoperative outcome like intraocular pressure (IOP), posterior synechiae, pigment deposits and posterior capsule opacification (PCO) were studied.
RESULTS
In both groups, age range varied between 2-8 years comprising 18 males and two females. The mean postoperative IOP did not show any significant variation during 6-month follow-up. In study group, all the 20 eyes were quiet at 2 weeks, while there was cellular reaction 1+ in four eyes (20%) and nil in 16 eyes (80%) at 2 week in the control group (p = 0.035). Pigment deposits on IOL optic was seen in two eyes (10%) of the study group while in control group, IOL deposits were present in 14 eyes (70%) (p = 0.001). Posterior capsule opacification was seen in two eyes (10%) in control group at 3 months while none occurred in study group.
CONCLUSIONS
Intra-operative use of preservative-free triamcinolone acetonide led to less anterior chamber inflammation and pigment deposits on IOL optic postoperatively compared to those eyes where it was not used.
Topics: Capsule Opacification; Case-Control Studies; Child; Child, Preschool; Female; Glucocorticoids; Humans; Intraocular Pressure; Intraoperative Complications; Lens Implantation, Intraocular; Male; Phacoemulsification; Posterior Capsulotomy; Preservatives, Pharmaceutical; Prospective Studies; Staining and Labeling; Treatment Outcome; Triamcinolone Acetonide; Uveitis, Anterior; Vitrectomy; Vitreous Body
PubMed: 24730623
DOI: 10.1111/aos.12375