microbial contamination of eye drops

OBJECTIVE: To study the physicochemical and microbiological stability over 90 days of two preservative-free methylprednisolone sodium succinate (MTPSS) 1 mg/ml and 10 mg/ml eye drops for use in ocular pathologies such as Sjögren's syndrome and dry eye syndrome. METHOD: The two eye drops were prepared from injectable MTPSS (Solu-moderin® and Urbason®), water for injection and normal saline solution. In accordance with ICH (International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use) guidelines, they were then stored in triplicate under refrigerated conditions (5 ±3 °C), at room temperature (25 ± 2 °C), and at 40 °C (±2 °C)...

Eye infections from bacterial contamination of bulk-refillable liquid soap dispensers and artificial tear eye drops continue to occur, resulting in adverse health outcomes that include impaired vision or eye enucleation. Pseudomonas aeruginosa ( P. aeruginosa ), a common cause of eye infections, can grow in eye drop containers and refillable soap dispensers to high numbers. To assess the risk of eye infection, a quantitative microbial risk assessment for P. aeruginosa was conducted to predict the probability of an eye infection for two potential exposure scenarios: (i) individuals using bacteria-contaminated eye drops and (ii) contact lens wearers washing their hands with bacteria-contaminated liquid soap prior to placing the lens...

PURPOSE: NHS Blood and Transplant Tissue and Eye Services provide a serum eye drop (SED) service to patients suffering from severe dry eye syndrome. Currently SED are dispensed using an automatic closed filling system (TF) manufactured by Meise Medizintechnik (Germany). An improved version (ATS) has recently been introduced by Meise, based on patient feedback on the TF system. ATS vials are easier to open, with a more secure, tamper evident closure and a better quality nozzle.To evaluate the suitability of ATS vials, a validation protocol, previously developed for TF vials, was repeated...

INTRODUCTION: NHS Blood and Transplant Tissue and Eye Services (TES) offer a serum eyedrop (SE) service to patients suffering from severe ocular surface disease. SE are prepared from serum collected at blood donation sessions; the serum is diluted 1:1 with physiological saline. Formerly, 3ml aliquots of diluted serum were aliquoted into glass bottles in a Grade B clean room. Since this service was started, Meise Medizintechnik have developed an automatic closed filling system consisting of tubing-linked chains of squeezable vials...

Patient safety risks associated with the online purchase of medications, especially in case of ophthalmic preparations, are significant. Our study aimed to carry out quality assessment of dorzolamide hydrochloride (DZA) and timolol maleate (TIM) eye drops preserved with benzalkonium chloride (BAC) via online test purchases. Three samples were purchased online, while control preparations were acquired through authorized national drug supply chain. Our method was based on the International Pharmaceutical Federation (FIP) Inspection Checklist and integrated the evaluation of packaging and labelling...

INTRODUCTION: Postoperative endophthalmitis is typically caused by the patient's conjunctival bacterial flora. Povidone iodine solution (5%) is used perioperatively to obtain periocular and ocular antisepsis. However, an adjunctive prophylaxis procedure could further help control the conjunctival microbial load. Considering the increase in antibiotic resistance, a progressive shift toward alternative methods would be desirable. Somilux® eye drops (Alfa Intes, lactoferrin-based eye drops) are medical devices containing liposomal lactoferrin (LF)...

The sterility of eye drop content is a primary concern from manufacturing until opening, as well as during handling by end users, while microbial contamination of the dropper tip and cap are often disregarded. The contamination of these sites during drug administration represents a risk of microbial transmission and ocular infection. In this review, we aim to assess microbial contamination of the dropper tip and cap of in-use eye drops, the associated contributory factors, and the risk of infection. We conducted a literature search of the MEDLINE, PubMed, and Cochrane Central databases...

BACKGROUND: Eye examinations for ROP screening in preterm newborns are characterized by two main problems: infection control and poor tear secretion. Therefore, in order to reduce the risk of ocular infection and to protect the ocular surface, Netilmycin eye drops are usually used after the exams. The purpose of our study was to evaluate the safety and tolerability of Ozonated-Oils Eyedrops during the eye examination of pre-term babies in the screening for ROP, sparing the use of antibiotics eyedrops...

The objective of this experimental study was to investigate the stability of functional proteins in human serum eye drops, which are used for the treatment of ocular surface disorders, after prolonged storage of 6 months at -20°C. After obtaining whole blood from 3 volunteers and preparing 100% (S100), 50% (S50), and 20% (S20) serum eye drops, fibronectin was quantified before and after storage for 6 months at -20°C using appropriate enzyme-linked immunoassay kits. The pH and microbial contamination of preparations were also evaluated longitudinally...

Preservative-free artificial tears eliminate the side effects of preservatives but are prone to microbial contamination. This study evaluates the incidence of microbial contaminations in single-use vials of preservative-free 0.1% hyaluronate artificial tears. Based on what touched the vial tip during its first use, 60 unit-dose vials (0.5 mL) were divided into groups A (no touch, n = 20), B (fingertip, n = 20), and C (lid margin, n = 20). The vials were recapped after the first use, and the residual solution was cultured 24 h later...

PURPOSE: To analyze the presence of microorganisms in fluorescein eyedrops used in a reference eye center in Recife-PE. METHODS: This real-life and masked study evaluated fluorescein eyedrops used at the Altino Ventura Foundation in May 2019. Cultures were performed according to exposure times; I) three eyedrop bottles were analyzed after one day of use, II) three eyedrop bottles after 4 d of use, III) three eyedrop bottles after 8 d of use, and IV) three unopened bottles used as control...

PURPOSE: To analyze the presence of microorganisms in fluorescein eyedrops used in a reference eye center in Recife-PE. METHODS: This real-life and masked study evaluated fluorescein eyedrops used at the Altino Ventura Foundation in May 2019. Cultures were performed according to exposure times; I) three eyedrop bottles were analyzed after one day of use, II) three eyedrop bottles after 4 d of use, III) three eyedrop bottles after 8 d of use, and IV) three unopened bottles used as control...

PURPOSE: The objectives of this study were to determine the prevalence of microbial contamination of multi-user preserved ophthalmic drops (POD) in Ophthalmology Outpatient Clinic (OOC), to compare the rate of contamination between the dropper tip and the residual contents in the bottle, and to identify the contaminating organisms. METHODS: This was an observational cross-sectional study using a convenience sampling method conducted in the OOC of Universiti Kebangsaan Malaysia Medical Center, Malaysia...

BACKGROUND: Multi-dose eye drops are easily contaminated by microorganisms, and reportedly, the highest contamination rate can reach 96.46%. The use of contaminated eye drops can cause serious eye infections. METHODS: Carteolol hydrochloride eye drops provided by glaucoma patients who visited the ophthalmic clinic of the First Affiliated Hospital of Soochow University from May 2018 to December 2019 were collected. Microbial culture was carried out on the eye drops, and the microbial species were identified by standard procedures...

A multicenter, nonrandomized, prospective, controlled study was conducted to evaluate, as perioperative prophylactic treatment, the anti-infective effectiveness of 0.66% povidone-iodine eye drops (IODIM® ) against the bacterial flora of the conjunctival surface of patients who undergo cataract surgery. Eye drops containing 0.66% povidone-iodine were applied to the eye undergoing cataract surgery; the untreated contralateral eye was used as control. One hundred and twenty patients set to receive unilateral cataract surgery were enrolled in 5 Italian Ophthalmology Centers and pretreated for three days with 0...

PURPOSE: To evaluate the antimicrobial effectiveness of a liposomal ozonized oil solution used as a home therapy in patients undergoing cataract surgery. Antimicrobial efficacy was evaluated as the reduction in the bacterial load of the most common bacteria isolated from cases with endophthalmitis. SETTING: 20 Italian experimental centers of the Effectiveness of Liposomal Ozonized oil on Ocular Microbial flora before cataract surgery study group. DESIGN: Interventional, nonrandomized, paired-eye designed, phase 4 clinical study...

PURPOSE: To analyze whether plasma rich in growth factors (PRGFs) eye drops preserve their activity and biological properties after storage for 9 and 12 months at -20°C, and at 4°C, and at room temperature (RT) for 3 and 7 days in comparison to fresh samples (t0). METHODS: PRGF eye drops were obtained from 6 healthy donors. Then, they were stored for 9 and 12 months at -20°C. At each time, different PRGF eye drops samples were thawed and maintained at RT or at 4°C for 3 and 7 days...

Eye drops are sterile preparations intended for instillation into the eye. All major pharmacopoeias require these products to pass the antimicrobial effectiveness test (AET). This test is similar to that used for oral dosage form despite the fact that both product categories differ in their microbiological specifications. The eye drops might pass the official requirements of the AET but in practice, contaminants introduced into the preparation might not be killed prior to its next use by the patient and this may compromise ocular health...

Background: Eye drops are most frequently used medications in ophthalmology. The carriage of pathogenic organisms to eyes through the agency of eye drops has presented a serious problem for several decades. The objective of this study was to determine the magnitude of contamination and pattern of antimicrobial resistance of in-use ophthalmic solutions. Method: A cross-sectional study was conducted at the Department of Ophthalmology, Jimma University Specialized Hospital (JUSH), Southwest Ethiopia, from June to December 2015...

OBJECTIVE: Galenic evaluation of the process for obtaining and storing the platelet rich in growth factors PRGF-Endoret® eye drops. METHOD: To assess whether the PRGF-Endoret® eye drops process is aseptically obtained, a sterility test was carried out on the eye drops; the tightness of the PRGF-Endoret® eye drops containers was also analyzed. Likewise, the chemical and biological properties of the PRGF- Endoret® eye drops were evaluated after the obtaining process and storage...