Active clinical trials for "Keratoconjunctivitis Sicca"

The purpose of the study is to observe lacrimal fluid condition (tear film break-up time) chronologically after a single dose of AL-43546 ophthalmic products（0.15%, 0.25% and vehicle）and 0.1% sodium hyaluronate ophthalmic solution and compare lacrimal fluid retention time between them.

The objective of this retrospective chart review is to evaluate the patient characteristics, treatment variations and efficacy of a second trial of Cyclosporine Ophthalmic Emulsion 0.05% therapy in chronic dry eye patients who were initially treated with Cyclosporine Ophthalmic Emulsion 0.05% but discontinued use after less than 12 weeks of treatment.

This is a multi-center, prospective, controlled, observational study of the natural history of patients with dry eye disease.

2017 International Dry Eye Workshop (DEWS) defines dry eye as a multifactorial ocular surface disease characterized by tear film instability with disturbed visual function. As a smooth transparent structure and the outmost layer of the whole ocular refractive system, tear film plays an important role. In dry eye, the instability of tear film caused by a lack of tear volume or high evaporation makes it more vulnerable to break up during blinking intervals, exposing the rough epithelium of the corneal surface and introducing extra aberrations and scatter. This would affect image sharpness on the retina and lower the optical quality. Also, it had been observed that the dynamic tear film scattering was reduced and the objective optical quality was improved transiently after artificial tears instillation. Though these findings supported the fact of visual quality impairment in dry eye. It remains unclear how does the tear film instability affect the visual quality in specific. Whether it lowers the optical quality of the whole ocular or just affects the tear-film associated part alone and whether there is a correlation with the tear film function are still unknown and to be answered. So we wondered whether there is a correlation between the tear film function and the related optical quality in dry eye. Though it had been inspected that the invasive tear break up time by fluorescein staining was positively correlated with the related scattering of tear film. To the newest dry eye diagnosis criteria of 2017 DEWS, the non-invasive tear break-up time has been amended to the first line instead of the invasive methods, e.g. fluorescein staining, which was thought to be less accurate and less credible. What's more, the invasive method of tear film evaluation might introduce confounding factors to the successive optical quality assessment. So we need a more accurate investigation to the relationships of the tear film function and the optical quality in dry eye. This study was intended to measure the non-invasive tear break-up time and the objective optical quality in normal people and dry eye patients to illustrate this question. In addition, we will investigate the relation of evolution trends of NIKBUT and objective optical quality under artificial tears for a better illustration.

This observational pilot-study is intended to collect outcome data from a cohort of 30 patients suffering from hyper-evaporative dry eye disease who are treated with the medical device NovaTears® eye drops for a duration of 5 to 7 weeks.

The ocular surface is the first line of defence of the eye, it is therefore where external threats are sensed, and potential insults neutralised. Over the course of evolution, various microbes, especially bacteriae, have come to colonise the ocular surface as commensals. The commensals have a role to maintain the homeostasis of the ocular surface. 1 The innate immunity of the ocular surface is very active, and consists of active mechanisms to suppress inflammation 2. For example, there exist macrophages, dendritic cells, suppressor cells, regulatory cells, B cells, IgA, lysozyme, anti-microbial peptides and barriers against external agents. The normal commensals of the ocular surface maintain a basal level of activation of innate defence by stimulating the pattern recognition receptors on ocular surface epithelial cells. This normal composition of microbes is important since inflammation and infection will result if there is introduction of a pathogenic strain that overcomes the flora, or if a dominant strain secretes excessively immunogenic products, such as the exotoxin A of Staphylococcus which triggers marginal keratitis, a form of type IV hypersensitivity. The flora load of microbiome could also influence tear function as a higher flora load was found to be associated with increased mucin degradation 3 and reduced globet cell densitiy 4. Previous studies [I'm not sure which studies these are] at SERI/SNEC also point to the importance of microbes. For example, in dry eye patients, there is increased lysophospholipids in the tear, and this may contribute to inflammatory mediators such as arachidonic acid and other metabolites. The lysophospholipids are formed by phospholipase A2 reactions, and the latter may be microbial in origin. Since dry eye is a known inflammatory disease of the ocular surface, this is one way that microbes can contribute to the pathology.

This is a comparative, open label, parallel group, non interventional study to further demonstrate the efficacy and tolerability of BAT04. In addition the efficacy and safety shall be compared to Hyaluronic acid (HA)-Product. The patient applies BAT04 or HA-Product according to the instructions for use six times daily in both eyes over a period of 28 days. Response to treatment is recorded at day 28.

This study will evaluate the prevalence of inflammatory dry eye disease in patients prior to cataract surgery. No treatment is administered in this study.

Dry eyes are a very common complaint. In some patients, we can identify the reason for the dryness; however, in others the dryness has no clear cause. Dryness can lead to eye irritation, redness, and sometimes changes in vision. Fibromyalgia is a condition of chronic pain that is poorly understood but seems to have a component of altered sensory processing. People with fibromyalgia tend to complain of dry and irritated eyes at a higher rate than the general population. We plan to evaluate patients with dry eye symptoms for abnormalities in sensory processing and in their autonomic nervous system. We hope to learn about possible relationships between dry eye symptoms and fibromyalgia in order to better understand and treat these conditions.

The benefits of artificial tears to relieve dry eye symptoms include, but are not limited to: stabilizing the tear film layer, fluid supplement action, improving visual acuity, and comfort. Studies have found a relationship between some of these benefits. For example, stabilization of the tear film is important not only to increase the tear break up time (TBUT), but is key in improving and maintaining visual acuity. These studies have alluded to the fact that there may or may not be a relationship between residence time and visual performance. Viscosity is one reason behind the uncertainty. Some solutions contain polymers which influence the ocular surface when contacted. This can impact residence time and ultimately visual performance. No prior research has explored the direct relationship between residence time and visual performance. Residence time refers to the duration at which the artificial tear resides on the eye. Methods have been developed to assess residence time by admixing fluorescent tracers to the solution and then measuring the amount of fluorescence over time. The caveat to methods using certain tracers has lead to uncertainty in elimination measurements due to corneal penetration or differing molecular weights (MW) from the active vehicle ingredient in the solution. For example, low-MW tracers can be eliminated at a different rate than higher-MW polymers. In addition, the low-MW tracers may be able to penetrate the corneal epithelium giving a false pre-corneal residence time. Meadows, Paugh, Joshi, and Mordaunt addressed this issue by developing a technique using a polymer which did not penetrate the cornea and had the same MW as the active ingredient in the solution FITC-dextran. Based on the assumption that similar weights are eliminated at the same rate, this technique has shown to be more economic, manageable, and amendable than previous procedures measuring residence time. Any ophthalmic drop has the potential to impact visual acuity upon instillation due to the effect it has on the tear layer components. Studies have observed that taking artificial tears continuously over time tends to stabilize the tear layer thus minimizing the immediate drop in contrast sensitivity upon instillation. Measuring the visual effect of artificial tears, using contrast sensitivity as a measure, provides valuable information about the therapeutic effect of artificial tears that are meant to stabilize the tear film, thus improving visual acuity in dry eye patients. But what about the patient? There is a difference between residence time and retention of effect- which is often what matters the most for patients. Retention of effect refers to the beneficial effect of the drop. Currently there is no real measure of retention of effect. Doctors can assess the tear film objectively, but there have been no strong correlations between subjective dry symptoms and tear film stability. A possible reason for the lack of correlation may be due to the fact that subjectivity is difficult to quantify. However, scales like the Visual Analog Scale (VAS) and Numerical Rating Scale (NRS) have been established in an attempt to quantify subjective experiences such as visual quality. We will be using the NRS to gauge the comfort of the drop upon the initial application to get a general idea of the comfort the drop provides to the user. Although there have been several studies done on residence time and visual effect of ophthalmic formulations separately, there is no current research correlating these two aspects of therapeutic efficacy. This study will be the first to concurrently investigate residence time (using FITC-dextran) and visual effect of an ophthalmic formulation.