Project description:To determine the associations between medical, demographic, socioeconomic, and ocular factors and adherence to topical glaucoma ocular hypotensive therapy.One hundred sixteen patients with ocular hypertension or open-angle glaucoma from 2 tertiary glaucoma services participated in this prospective study. Adherence to ocular hypotensive therapy was measured using an electronic dose monitor (Travatan Dosing Aid, Alcon Laboratories Inc., Fort Worth, TX) and collected data at 3 months after enrollment. We used 3 different definitions of adherence: 1) Definition 1: the proportion of days taking the prescribed number of drops within 3 hours of the prescribed dosing time; 2) Definition 2: the proportion of days taking any drops within 3 hours of the prescribed dosing time; and 3) Definition 3: the proportion of days taking any drops within 6 hours of the prescribed dosing time. Univariate and multivariate models were used to determine the association between the 3 adherence definitions, medical, demographic, socioeconomic, and ocular factors at 3-month follow-up. The main outcome measures for this study were risk factors for poor objective medication adherence.Adherence, using Definition 1, Definition 2, and Definition 3, was 64%, 75%, and 80%, respectively. Age, total number of other eye diseases, and race were significantly associated with full treatment adherence (Definition 1), with race alone significantly predicting 11% of full treatment adherence. For Definition 2, age, income, level of education, and total number of eye diseases were significantly associated with partial adherence (3 h), again race alone significantly predicted 15% of partial adherence (any drops within 3 h). For Definition 3, race, income, level of education, and total number of other eye diseases significantly predicted partial adherence (any drops within 6 h), both race and income predicted 19% of partial treatment adherence. Significant differences for adherence rates between patients of European descent and those of African descent were found for all 3 definitions with those who were less adherent more likely to be of African descent.Electronic dose monitors provide important information regarding adherence to topical ocular hypotensive medications in glaucoma patients. Electronic dose monitors show low adherence in a significant number of participants. Future studies are needed to determine the reasons for these differences in health behaviors related to glaucoma treatment, which should guide treatment of poor adherence with glaucoma therapy.
Project description:Preservatives continue to be in widespread use in ophthalmic medications due to the convenience they provide, regulatory requirements and the higher cost of alternatives. Benzalkonium chloride (BAK) remains the most commonly used preservative but there is a trend towards the use of preservative-free (PF) drops for glaucoma, although at a higher price. An extensive body of literature explores BAK toxicity on ocular structures in animal and laboratory studies (in vitro and in vivo). Non-randomised controlled studies have provided some supporting evidence of its toxicity in patients, especially in those with pre-existing ocular surface disease (OSD) or on multiple medications. However, there have been very few randomised controlled trials that compare the same medication with and without BAK preservative. Several of these trials have never been published in any peer reviewed journals. Notwithstanding, those that have been published, have not demonstrated any clear benefits of the BAK-free formulations. Short duration and exclusion of those with OSD are limitations of these studies. There is a lack of evidence of clinically significant harm from a small number of BAK preserved drops in patients without OSD. This means that generally more expensive PF glaucoma medications should only be recommended for those on poly pharmacy or those with OSD but are not necessarily required for all patients.
Project description:PURPOSE:To assess the safety and efficacy of one, two, or three trabecular microbypass stents in eyes with primary open-angle glaucoma (OAG) not controlled on ocular hypotensive medication. A total of 119 subjects were followed for 18 months postoperatively. MATERIALS AND METHODS:Subjects with medicated intraocular pressure (IOP) 18-30 mmHg and postmedication-washout baseline IOP 22-38 mmHg were randomized to implantation of one, two, or three stents. Ocular hypotensive medication was to be used if postoperative IOP exceeded 18 mmHg. RESULTS:A total of 38 subjects were implanted with one stent, 41 subjects with two stents, and 40 subjects with three stents. Both month 12 IOP reduction ?20% without ocular hypotensive medication vs baseline unmedicated IOP and month 12 unmedicated IOP ?18 mmHg were achieved by 89.2%, 90.2%, and 92.1% of one-, two-, and three-stent eyes, respectively. Furthermore, 64.9%, 85.4%, and 92.1% of the three respective groups achieved unmedicated IOP ?15 mmHg. Over the 18-month follow-up period, medication was required in seven one-stent subjects, four two-stent subjects, and three three-stent subjects. At 18 months, mean unmedicated IOP was 15.9±0.9 mmHg in one-stent subjects, 14.1±1.0 mmHg in two-stent subjects, and 12.2±1.1 mmHg in three-stent subjects. Month 18 IOP reduction was significantly greater (P<0.001) with implantation of each additional stent, with mean differences in reduction of 1.84 mmHg (95% confidence interval 0.96-2.73) for three-stent vs two-stent groups and 1.73 mmHg (95% confidence interval 0.83-2.64) for two-stent vs one-stent groups. Adverse events through 18 months were limited to cataract progression with best-corrected visual acuity loss and subsequent cataract surgery. CONCLUSION:In this series, implantation of each additional stent resulted in significantly greater IOP reduction with reduced medication use. Titratability of stents as a sole procedure was shown to be effective and safe, with sustained effect through 18 months postoperatively in OAG not controlled with medication.
Project description:We investigated the delivery of drugs to the posterior segment of the eye by non-invasive topical instillation using submicron-sized poly(D,L-lactide-co-glycolide) (PLGA) nanoparticles (NPs). Surface-modified PLGA NPs were developed to improve the drug delivery efficiency to the retina and were administered as topical eye drops to mice. Chitosan (CS) and glycol chitosan (GCS), which are mucoadhesive polymers, and polysorbate 80 (P80) were used as surface modifiers, and have been reported to increase the association of NPs with cells. Coumarin-6 was used as a model drug and fluorescent marker, and after ocular administration of PLGA NP eye drops, the fluorescence intensity of coumarin-6 was observed in the retina. The fluorescence image analysis indicated that there are several possible routes to the retina and fates of PLGA NPs in ocular tissue, and that these pathways involved the corneal, non-corneal, or uveal routes. Delivery to the mouse retina segments after topical administration was increased by surface modification with CS, GCS, or P80. Surface-modified PLGA NPs are a promising method for retinal drug delivery via topical instillation.
Project description:A clinical trial assessed the cutaneous immune response and short-term efficacy, safety, and tolerability in adults with mild to moderate AD who applied SB414 2% and 6% BID for 2 weeks.
Project description:ObjectivesWe evaluated early medication persistence with new topical antiglaucoma eyedrops, omidenepag isopropyl 0.002% (a selective prostaglandin EP2 agonist).Design and settingRetrospective two-institute study in Himeji and Akashi in Japan.ParticipantsWe analysed patients with glaucoma who were prescribed topical omidenepag isopropyl from November 2018 to December 2019. From the last outpatient visit of patients until February 2020, 235 patients were prescribed a new solution of omidenepag isopropyl (129 patients in the initial monotherapy group, 85 in the switching group (switched from another topical antiglaucoma eyedrops), 19 added to another topical antiglaucoma eyedrops group, and 2 were lost to follow-up)). Additionally, we recruited 98 patients (3 were lost to follow-up) who received initial latanoprost 0.005% monotherapy during the same period as a control group.OutcomesMedication persistence failure was defined as drug discontinuation due to any adverse effects or change of therapy. Kaplan-Meier survival analysis was performed with a Cox regression analysis.ResultsAmong 233 patients, 48 (20%) showed failure of treatment; the median persistence time of all patients was 165 days, and the median time until discontinuation of omidenepag isopropyl was 45 days. The total persistence rates were 85%, 80% and 70% at 3, 6 and 12 months, respectively. Risk factors for failure were male gender (HR: 1.45, p=0.023) and monotherapy/switching (HR: 1.715, p=0.002). Comparison between latanoprost and omidenepag isopropyl monotherapy, only male gender (HR: 1.43, p=0.016) was a significant risk factor. Failures associated with omidenepag isopropyl were due to insufficient intraocular pressure-lowering efficiency (n=26, observed during all the period), followed by conjunctival hyperaemia (n=10) and visual acuity disturbance (n=5) in patients who were observed until 3 months.ConclusionMedication persistence with omidenepag isopropyl is mostly positive; however, clinicians should also be cautious of early failure.
Project description:PurposeThe majority of patients with glaucoma do not take their medications as prescribed. Estimates of the cost-utility value of adherence to prescribed glaucoma medication are vital to implement potentially effective interventions.DesignCost-utility analysis using Monte Carlo microsimulations incorporating a series of Markov cycles (10 000 iterations per strategy).ParticipantsPatients with glaucoma aged ≥40 years with a full lifetime horizon (up to 60 years).MethodsThe analysis estimated glaucomatous progression on the basis of data from the United Kingdom Glaucoma Treatment Study. Participants with glaucoma entered the model at age 40 years with a mean deviation in the better-seeing eye of -1.4±-1.9 decibels (dB) and -4.3±-3.4 dB in the worse-seeing eye. Participants whose glaucoma worsened each year accumulate -0.8 dB loss compared with -0.1 dB loss for those who remained stable. Data from the Glaucoma Laser Trial and the Tube versus Trabeculectomy Studies were used to assign probabilities of worsening disease among treated patients. Claims data estimating rates of glaucoma medication adherence over 4 years were used to assign probability of adherence. Those with poor adherence were modeled as having outcomes similar to the placebo arm of the clinical trials. As patients' mean deviation deteriorated, they transitioned between health states from mild (≥-6 dB), to moderate (<-6 to ≥-12 dB), to severe glaucoma (<-12 to ≥23 dB), to unilateral (<-20 dB) and bilateral blindness. At each health state, patients incurred the costs of treatment and established health utilities; ultimately, societal costs of low vision and blindness were included.Main outcome measuresCost and quality-adjusted life year (QALY) of glaucoma medication adherence.ResultsBeginning at an initial glaucoma diagnosis at age 40 years, patients proceeded to single-eye blindness as early as 19 years among those who were nonadherent and 23 years for those remaining adherent. Total healthcare costs for adherent patients averaged $62 782 (standard deviation [SD], 34 107), and those for nonadherent patients averaged $52 722 (SD, 38 868). Nonadherent patients had a mean loss of 0.34 QALYs, resulting in a cost-effectiveness ratio of $29 600 per QALY gained.ConclusionAt a conservative willingness to pay of $50 000/QALY, there is room to expand services to improve patient adherence.
Project description:PurposeTo create a standardized method for evaluating the video recordings of patients self-instilling eye drops and to determine the level of agreement of eye drop instillation efficacy, safety and efficiency ratings by three masked graders.DesignProspective cross-sectional study.Participants78 patients with open-angle glaucoma or ocular hypertension who had at least 6 months of experience with the use of eye drop medications.MethodsParticipants were video recorded while self-instilling artificial tears sequentially to both eyes. Three masked observers graded these video recordings on three criteria: efficacy (the determination of whether an eye drop was instilled on the ocular surface), safety (assessment of whether the tip of the medication bottle made contact with the ocular surface or eyelids), and efficiency (the number of eye drops expressed from the bottle).Main outcome measuresAfter grading the video recordings based on efficacy, safety, and efficiency, kappa statistics were used to estimate inter-rater agreement.ResultsThe mean kappa level of agreement for efficacy, safety, and efficiency was 0.64 (95% confidence interval (CI), 0.42-0.87), 0.73 (95% CI, 0.58-0.88), and 0.62 (95% CI, 0.42-0.81), respectively.ConclusionsWe demonstrated good inter-rater reproducibility of the masked analysis of video recordings of patients self-instilling eye drops based on three criteria: efficiency, safety, and efficacy.
Project description:PurposeThe aim of this study was to investigate the frequency of eyedrop instillation failure and its related physical and visual function factors among glaucoma patients who used hypotensive eyedrops daily.Subjects and methodsPatients with a history of self-instillation of one or more ocular hypotensive ophthalmic solutions for six or more months were enrolled. Definitions of instillation failure were eyedrop instillation other than on the eye surface; eyedrop contact with eyelashes; eyedrop bottle tip contact with the eyelashes, eye surface or ocular adnexa; or two or more drops instilled with one instillation trial. To clarify factors related to instillation failure, we used visual function tests and investigated cervical spine extension angles during instillation, pinching strength, physical ataxia (evaluated using the Scale for the Assessment and Rating of Ataxia), motor dysfunction of the upper limbs (evaluated using the Disabilities of the Arm, Shoulder and Hand questionnaire), and vision quality (evaluated using the National Eye Institute Visual Function Questionnaire 25).ResultsOf 103 total subjects, 61.2% satisfied the definition of instillation failure. Instillation of the eyedrop other than at the cul-desac (76.2%) was the most frequent reason for failure, followed by contact of the tip of the eyedrop bottle (22.2%) and instillation of the same or more than two eyedrops in a single attempt (11.1%). Advanced age, a shallow cervical spine extension angle, weak pinching strength, poor motor dysfunction of the upper limbs, the degree of ataxia, poor best-corrected visual acuity, and visual field scores were significant risk factors for instillation failure. Vision quality may have some relation to instillation failure.ConclusionIt is highly recommended that instillation failure be routinely investigated even among patients with adequate experience using eyedrops and that correct therapies are chosen in a patient-based fashion.
Project description:BACKGROUND: Local tolerance of topical glaucoma treatment is important to achieve a good compliance. The aim of this study was to evaluate the consequences of local anti-glaucoma drug side effects on the vision-related quality of life (QoL). METHODS: A mail survey was sent to 20,000 homes of a panel representative of the French population asking whether one member of the family was suffering from ocular hypertension (OHT) or glaucoma. (POAG) A computer-assisted telephone interviewing system was used to confirm self-reported glaucoma, to describe the disease and its treatment, and medical item consumption. Vision-related QoL was assessed with the NEI-VFQ-25 (National Eye Institute Visual - Function Questionnaire) and local tolerance with the COMTOL (Comparison of Ophthalmic Medications for TOLerability). RESULTS: 13,352 homes (66.7%) answered the mail. 581 people declared they were suffering from glaucoma or OHT. Prevalence was 1.8%, increasing with age. 204 patients were selected at random Their NEI-VFQ-25 global score showed an overall good QoL. Two domain scores showed some deterioration: general health and driving. 62.4% of the patients cited at least one local side effect. 25.4% had burning, 20.8% blurred vision and 20.2% tearing. Poor vision related QoL was associated with the presence of local side effects leading to poor perceived treatment satisfaction. Dissatisfied patients visited their ophthalmologist more frequently. CONCLUSION: Based on a representative French sample, poor vision related QoL was associated with topical drug side effects that also impact patient satisfaction and compliance. Longitudinal data collection should be performed to confirm our findings.