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Korean Journal of Ophthalmology : KJO Jun 2021To evaluate the safety and efficacy of preservative-free (PF) latanoprost in glaucoma patients. (Observational Study)
Observational Study
PURPOSE
To evaluate the safety and efficacy of preservative-free (PF) latanoprost in glaucoma patients.
METHODS
In this prospective, open-label, observational study, a total of 27 primary open-angle glaucoma patients who used benzalkonium chloride-preserved prostaglandin analogues for at least 6 months were enrolled. After changing the eye drops to PF lataprost, the intraocular pressure (IOP) and ocular surface symptoms and signs were evaluated in all patients on days 0 (first visit, D0), 45 (D45), and 90 (D90).
RESULTS
Mean IOP remained stable during the study period (14.0 ± 2.4 mmHg at D0, 13.9 ± 2.0 mmHg at D45, 13.7 ± 2.2 mmHg at D90; p = 0.603). Mean deviation, pattern standard deviation, and best-corrected visual acuity were similar before and after eye drops replacement. Bulbar conjunctival hyperemia, corneal staining, and conjunctival staining were significantly decreased over 90 days (p = 0.025, p < 0.001, p = 0.020, respectively). The ocular surface disease index score showed a statistically significant improvement from 26.4 ± 18.5 at D0 to 19.8 ± 17.0 at D45 and 15.7 ± 15.6 at D90 (p < 0.001). In the evaluation of ocular tolerability, burning symptoms and dryness were significantly decreased (p = 0.001, p = 0.040).
CONCLUSIONS
The effects of PF latanoprost on reducing IOP were comparable with those of benzalkonium chloride-preserved prostaglandin analogues, but side effects on the ocular surface were much less pronounced when PF latanoprost was used. With this efficacy, PF latanoprost could slow the progression of glaucoma by increasing patient compliance.
Topics: Antihypertensive Agents; Glaucoma, Open-Angle; Humans; Intraocular Pressure; Latanoprost; Ocular Hypertension; Ophthalmic Solutions; Preservatives, Pharmaceutical; Prospective Studies; Prostaglandins F, Synthetic; Prostaglandins, Synthetic
PubMed: 34120423
DOI: 10.3341/kjo.2021.0010 -
Korean Journal of Ophthalmology : KJO Aug 2015Chronic use of topical hypotensive agents induces several side effects caused by preservatives. The purpose of this study was to evaluate the effects of prostaglandin...
PURPOSE
Chronic use of topical hypotensive agents induces several side effects caused by preservatives. The purpose of this study was to evaluate the effects of prostaglandin analogs with varying concentrations of benzalkonium chloride (BAC), preservative-free (PF), and alternative preservatives on mouse corneal tissue.
METHODS
Thirty-five, 8- to 10-week-old female C57BL/6 mice (five mice for each group) were used for this study. To the control group, we applied normal saline, and to each drug-treated group we applied 0.02% BAC, bimatoprost 0.01% (with BAC 0.02%), latanoprost 0.005% (with BAC 0.02%), travoprost 0.004% (with 0.001% polyquad) or tafluprost 0.0015% with/without 0.001% BAC, once a day (9 p.m.) for 4 weeks. Corneal fluorescein staining was evaluated in all groups. After harvest, the corneal tissues were embedded in paraffin and then Hematoxylin-Eosin stain was performed for histopathological examination. Immunofluorescence staining was done against TNF-α, IL-6, HLA DR, pJNK, and pAkt.
RESULTS
In corneal fluorescein staining, severe punctate epithelial keratitis was seen in the groups of 0.02% BAC, 0.02% BAC containing bimatoprost 0.01% and latanoprost 0.005%. The surface desquamation, irregular surface, loss of cell borders, anisocytosis and stromal shrinkage were observed in the groups of BAC-containing eye drops. Moreover, the groups treated with BAC-containing eye drops have high inflammatory markers, significantly decreased cell viability-related signal, pAkt, and higher apoptosis-inducing signal, pJNK, than the control group. On the other hand, travoprost 0.004% and PF tafluprost 0.0015% have less cellular morphologic changes, lower inflammation, and higher cellular viability than BAC-containing formulations.
CONCLUSIONS
Corneal damage, increased inflammation and apoptosis and low cell viability were observed in BAC-containing groups. PF or alternatively preserved glaucoma medications seem to be a reasonable and viable alternative to those preserved with BAC.
Topics: Animals; Cell Survival; Conjunctiva; Disease Models, Animal; Epithelium, Corneal; Female; Glaucoma; Mice; Mice, Inbred C57BL; Microscopy, Fluorescence; Ophthalmic Solutions; Preservatives, Pharmaceutical; Prostaglandins, Synthetic
PubMed: 26240512
DOI: 10.3341/kjo.2015.29.4.270 -
Korean Journal of Ophthalmology : KJO Dec 2013Long-term use of topical medication is needed for glaucoma treatment. One of the most commonly prescribed classes of hypotensive agents are prostaglandin analogs (PGs)...
PURPOSE
Long-term use of topical medication is needed for glaucoma treatment. One of the most commonly prescribed classes of hypotensive agents are prostaglandin analogs (PGs) used as both first-line monotherapy; as well as in combination therapy with other hypotensive agents. Several side effects of eye drops can be caused by preservatives. The purpose of this study was to evaluate the effects of PGs with varying concentrations of benzalkonium chloride (BAC), alternative preservatives, or no preservatives on human conjunctival fibroblast cells.
METHODS
Primary human conjunctival fibroblast cells were used in these experiments. Cells were exposed to the following drugs: BAC at different concentrations, bimatoprost 0.01% (with BAC 0.02%), latanoprost 0.005% (with BAC 0.02%), tafluprost 0.0015% with/without 0.001% BAC and travoprost 0.004% (with 0.001% Polyquad) for 15 and 30 minutes. Cell cytotoxicity was evaluated by phase-contrast microscopy to monitor morphological changes of cells, Counting Kit-8 (CCK-8) assay to cell viability, and fluorescent activated cell sorting (FACS) analysis to measure apoptosis.
RESULTS
BAC caused cell shrinkage and detachment from the plate in a dose-dependent manner. Morphological changes were observed in cells treated with bimatoprost 0.01% and latanoprost 0.005%. However, mild cell shrinkage was noted in cells treated with tafluprost 0.0015%, while a non-toxic effect was noted with travoprost 0.004% and preservative-free tafluprost 0.0015%. CCK-8 assay and FACS analysis showed all groups had a significantly decreased cell viability and higher apoptosis rate compared with the control group. However, travoprost 0.004% and preservative-free tafluprost 0.0015% showed lower cytotoxicity and apoptosis rate than other drugs.
CONCLUSIONS
This in vitro study revealed that BAC-induced cytotoxicity is dose-dependent, although it is important to emphasize that the clinical significance of toxicity differences observed among the different PGs formulations has not yet been firmly established. Alternatively preserved or preservative-free glaucoma medications seem to be a reasonable and viable alternative to those preserved with BAC.
Topics: Apoptosis; Cell Line; Cell Survival; Conjunctiva; Fibroblasts; Glaucoma; Humans; Preservatives, Pharmaceutical; Prostaglandins, Synthetic
PubMed: 24311931
DOI: 10.3341/kjo.2013.27.6.446 -
British Journal of Anaesthesia Jan 2004
Topics: Analgesics; Anesthesia, Caudal; Child; Humans; Ketamine; Preservatives, Pharmaceutical
PubMed: 14665573
DOI: 10.1093/bja/aeh501 -
Journal of Optometry 2017This study aimed to compare the efficacy of two sustained-release formulation of artificial tear drops. (Comparative Study)
Comparative Study Randomized Controlled Trial
PURPOSE
This study aimed to compare the efficacy of two sustained-release formulation of artificial tear drops.
PATIENTS AND METHODS
This is a randomized patient-masked clinical trial, a total 88 patients into two group A (n=41; with single dose of artificial tear, containing dextran 70, 1mg/ml and hypromellose, 3mg/ml hydroxypropyl methylcellulose (HPMC) and group B (n=47; with multidose of artificial tear, containing 0.3g HPMC and 0.1g of dextran 70, with 0.01% benzalkonium chloride (BAK) as preservative) were completed the study. The ocular surface disease index (OSDI) questionnaire, tear break up time (TBUT), corneal and conjunctival staining and Schirmer test, were performed. Repeated measures ANOVA was used to assess the differences among the two products. A p-value less than 0.05 was considered significant.
RESULTS
The mean of age of the participants in the Group A and B was 44.08±6.29 (range, 33-58 years) years and 45.83±8.42 (31-60 years), respectively. In comparing two groups before the intervention, the OSDI scores, the TBUT scores, the conjunctival and corneal staining scores and the Schirmer scores did not show statistically significant differences (p=0.339, p=0.640, p=0.334, p=0.807 and p=0.676, respectively). After 4 weeks, the OSDI scores, conjunctival and corneal staining scores showed improvement in compare to those before the intervention (p<0.001). But, the differences for the Schirmer test score and TBUT score was not significant (p=0.115, p=0.013, respectively).
CONCLUSION
Our outcomes indicated that improvement occurred with use of both products but there was no statistically significant difference between them.
Topics: Administration, Ophthalmic; Adult; Benzalkonium Compounds; Cornea; Dextrans; Drug Combinations; Dry Eye Syndromes; Eyelids; Female; Humans; Hypromellose Derivatives; Lubricant Eye Drops; Male; Middle Aged; Ophthalmic Solutions; Preservatives, Pharmaceutical; Single-Blind Method; Surveys and Questionnaires; Tears; Treatment Outcome
PubMed: 27989693
DOI: 10.1016/j.optom.2016.11.002 -
Molecules (Basel, Switzerland) Mar 2024Cosmetic products are chemical substances or mixtures used on the skin, hair, nails, teeth, and the mucous membranes of the oral cavity, whose use is intended to clean,... (Review)
Review
Cosmetic products are chemical substances or mixtures used on the skin, hair, nails, teeth, and the mucous membranes of the oral cavity, whose use is intended to clean, protect, correct body odor, perfume, keep in good condition, or change appearance. The analysis of cosmetic ingredients is often challenging because of their huge complexity and their adulteration. Among various analytical tools, mass spectrometry (MS) has been largely used for compound detection, ingredient screening, quality control, detection of product authenticity, and health risk evaluation. This work is focused on the MS applications in detecting and quantification of some common cosmetic ingredients, i.e., preservatives, dyes, heavy metals, allergens, and bioconjugates in various matrices (leave-on or rinse-off cosmetic products). As a global view, MS-based analysis of bioconjugates is a narrow field, and LC- and GC/GC×GC-MS are widely used for the investigation of preservatives, dyes, and fragrances, while inductively coupled plasma (ICP)-MS is ideal for comprehensive analysis of heavy metals. Ambient ionization approaches and advanced separation methods (i.e., convergence chromatography (UPC)) coupled to MS have been proven to be an excellent choice for the analysis of scented allergens. At the same time, the current paper explores the challenges of MS-based analysis for cosmetic safety studies.
Topics: Cosmetics; Perfume; Allergens; Preservatives, Pharmaceutical; Mass Spectrometry; Coloring Agents; Metals, Heavy
PubMed: 38542972
DOI: 10.3390/molecules29061336 -
Dermatology (Basel, Switzerland) 1992
Topics: Cosmetics; Dermatitis, Contact; Europe; Humans; Preservatives, Pharmaceutical; Product Labeling; Thiazoles
PubMed: 1498384
DOI: 10.1159/000247509 -
Journal of Pharmaceutical Sciences Mar 2023Multi-injection pharmaceutical products such as insulin must be formulated to prevent aggregation and microbial contamination. Small-molecule preservatives and nonionic...
Multi-injection pharmaceutical products such as insulin must be formulated to prevent aggregation and microbial contamination. Small-molecule preservatives and nonionic surfactants such as poloxamer 188 (P188) are thus often employed in protein drug formulations. However, mixtures of preservatives and surfactants can induce aggregation and even phase separation over time, despite the fact that all components are well dissolvable when used alone in aqueous solution. A systematic study is conducted here to understand the phase behavior and morphological causes of aggregation of P188 in the presence of the preservatives phenol and benzyl alcohol, primarily using small-angle x-ray scattering (SAXS). Based on SAXS results, P188 remains as unimers in solution when below a certain phenol concentration. Upon increasing the phenol concentration, a regime of micelle formation is observed due to the interaction between P188 and phenol. Further increasing the phenol concentration causes mixtures to become turbid and phase-separate over time. The effect of benzyl alcohol on the phase behavior is also investigated.
Topics: Poloxamer; Micelles; Scattering, Small Angle; X-Rays; X-Ray Diffraction; Surface-Active Agents; Water; Preservatives, Pharmaceutical; Phenols; Benzyl Alcohols; Solutions
PubMed: 36150467
DOI: 10.1016/j.xphs.2022.09.019 -
International Journal of Environmental... Apr 2020Contact allergy (sensitisation) and allergic contact dermatitis (ACD) resulting from it have a considerable public health impact. For the present review, all pertinent... (Review)
Review
Contact allergy (sensitisation) and allergic contact dermatitis (ACD) resulting from it have a considerable public health impact. For the present review, all pertinent articles were systematically searched via Medline and Web of Science™; additionally, all available issues of the journals "Contact Dermatitis" and "Dermatitis" were manually searched, covering the years 2018-2019, thereby extending and re-focusing a previous similar review. New allergens, or previously described allergens found in a new exposure context or of other current importance, are described in sections according to substance classes, e.g., metals, preservatives, fragrances. As a common finding in many investigations, a lack of information on product composition has been noted, for instance, regarding a newly described allergen in canvas shoes (dimethylthiocarbamylbenzothiazole sulfide) and, most notably, absence of co-operation from manufacturers of glucose-monitoring devices and insulin pumps, respectively. These latter devices have been shown to cause severe ACD in a considerable number of diabetic patients caused by the liberation of isobornyl acrylate and N,N'-dimethylacrylamide, respectively, as demonstrated by an international collaboration between dermatologists and chemists. Improved and complete ingredient labelling for all types of products, and not just cosmetics, must be put on the legislative agenda.
Topics: Allergens; Cosmetics; Dermatitis, Allergic Contact; Humans; Patch Tests; Perfume; Preservatives, Pharmaceutical; Public Health
PubMed: 32244763
DOI: 10.3390/ijerph17072404 -
Journal of Ocular Pharmacology and... May 2019Effective glaucoma therapy relies to a great extent on the patients' ability to regularly self-administer eye drops. This study aimed to assess self-reported...
Effective glaucoma therapy relies to a great extent on the patients' ability to regularly self-administer eye drops. This study aimed to assess self-reported nonadherence and to identify potential barriers to adherence in glaucoma patients. Participants completed a 16-item questionnaire, designed to examine nonadherence rate and assess the therapy experience. Inclusion criteria stipulated treatment duration of at least 1 year. Nonadherence was defined as missing ≥5% of the prescribed pressure-lowering eye drops doses. In total, 201 glaucoma patients aged 24-88 years were included. Mean treatment duration was 9.4 years. Nonadherence was reported by 30.3% of participants and 69.7% were reported to be adherent. Individuals who experienced side effects reported higher levels of nonadherence than those who did not (37.6% vs. 18.4%; = 0.004). Eye drops with preservatives were used by 84.1% of participants, 11.9% were on combined preservative and preservative-free treatment, and 4.0% on preservative-free medication only. Self-reported nonadherence levels were 32.0%, 25.0%, and 12.5%, respectively, for each of these groups. Men reported higher rates of nonadherence than women (36.8% vs. 24.5%; = 0.066). Age, social status, history of migration, severity of disease, and fear of blindness were not associated with significant differences in nonadherence levels. Nonadherence with glaucoma therapy is a significant barrier to therapeutic success for approximately one-third of patients. Nonadherence may be reduced if side effects are avoided. Preservative-free products may provide adherence benefits. The patient experience should be a key consideration when selecting appropriate treatments, to reduce nonadherence and optimize outcomes.
Topics: Adult; Aged; Aged, 80 and over; Antihypertensive Agents; Female; Germany; Glaucoma; Humans; Injections, Intraocular; Male; Middle Aged; Ophthalmic Solutions; Patient Compliance; Patient Reported Outcome Measures; Preservatives, Pharmaceutical; Surveys and Questionnaires; Young Adult
PubMed: 30897019
DOI: 10.1089/jop.2018.0134