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38 active trials for Dry Eye Syndromes

The Effect of 3% Diquafosol Ophthalmic Solution on Visual Display Terminal-associated Dry Eye

This study aims to evaluate the efficacy and safety of 3% Diquafosol Ophthalmic Solution for visual display terminal (VDT)-associated dry eye and to investigate the mechanism of treatment.

Start: January 2021

Platelet Rich Plasma Eye Drops for Treatment of Ocular Surface Disease

The purpose of this study is to evaluate prospectively the efficacy of topical administration of autologous platelet rich plasma as monotherapy for the treatment of symptoms and clinical signs in cases affected by moderate to severe forms of ocular surface disease

Start: January 2021

Efficacy of T2259 in DED

The purpose of this study is to compare the performance and safety of T2259 versus Vismed Multi in dry eye patients with superficial keratitis.

Start: February 2019

Umbilical Cord Serum Versus Conventional Eyedrops

Dry eye disease (DED) is a chronic ocular surface disease and the prevalence of DED has been reported as high as 50%. Recently, The international Dry Eyes Workshop II (DEWS II) defines dry eye as a "multifactorial disease of the ocular surface characterized by a loss of homeostasis of the tear film, and accompanied by ocular symptoms, in which tear film instability and hyperosmolarity, ocular surface inflammation and damage, and neurosensory abnormalities play etiological roles". A study done by Yoon et al. on 31 patients with severe DED concluded that UCS eye drops are effective and safe in treating severe DED. Studies found that EGF, TGF-?, VEGF and vitamin A levels were significantly higher in UCS than peripheral blood serum(PBS) whereas IGF content was significantly higher in PBS than in CBS. Yoon et al. then conducted another study whereby he compared UCS to AS in treating both Sjögren syndrome and non- Sjögren syndrome patients with severe dry eyes. They concluded that UCS eye drops were more effective in decreasing symptoms and keratoepitheliopathy in severe dry eye syndrome and increasing goblet cell density in Sjögren syndrome compared with AS drops. Despite proven more effective in treating DED, serum eye drops are not yet widely manufactured due to a few reasons. This study is chosen because Not many previous clinical trials done related to UCS eye drops. There were only two clinical trials done before to compare the use of UCS eye drops versus conventional AT eye drops on Hansen's disease and acute ocular chemical burn injury population. To apply the newer technology of Keratograph® 5M in DED assessment. To initiate a proper standard operating procedure for production as well as delivery of serum eye drops which allowing out-patient treatment with serum eye drops possible.

Start: January 2020

Lipiflow Treatment Alone vs. Lipiflow + Dextenza Treatment for Dry Eye Disease

To evaluate the benefit of treatment with a physician administered intracanalicular dexamethasone insert in evaporative dry eye disease (DED) patients with meibomian gland disfunction (MGD) and underlying inflammation undergoing LipiFlow Thermal Pulsation.

Start: August 2020

Xiidra vs. Xiidra + Dextenza Treatment for Dry Eye Disease

To evaluate the benefit of treatment with a physician administered intracanalicular dexamethasone insert in patients with dry eye who are beginning treatment with Xiidra (lifitegrast ophthalmic solution) to reduce the signs and symptoms of dry eye disease.

Start: August 2020

Clinical Investigation to Assess the Efficacy and the Safety of VisuXL® Gel Administered in Patients Affected by Moderate DED

This is a post-market, european multicenter study. This is a randomized, cross-over, double blind study with competitive enrolment, aimed to enroll a total of 90 patients with a diagnosis of moderate dry eye disease (DED).

Start: July 2020

Effect of Micropulse Laser on Dry Eye Disease Due to Meibomian Gland Dysfunction

The modern treatment of meibomian gland dysfunction(MGD) is based on anti-inflammatory drops or oral antibiotics for decreasing dry eye disease (DED) associated inflammation, warm compresses for liquefying the thicker meibum, and lid hygiene for reducing the bacterial overload. But, such treatments have shown limited effectiveness to a large proportion of patients with MGD, due to the multifactorial background of the disease. Thus, alternative approaches aiming at different aspects of the DED pathophysiology are needed. Elimination of posterior lid-margin hyperemia with telangiectasia could be a treatment target for reducing the secretion of inflammatory mediators in the course of MGD. Using the mechanism of photocoagulation via selective thermolysis, laser light could contribute to the destruction of abnormal vessels at the posterior lid-margin and thus, the reduction of inflammation. Recently, sub-threshold (micropulse) laser photocoagulation was introduced in ophthalmology and offers significant clinical advantages compared to conventional continuous wave (CW) approach, preventing laser induced thermal damage and related treatment side effects. This study investigates the effect of sub-threshold (micropulse) laser treatment for dry eye disease due to meibomian gland dysfunction combined with increased eyelid margin vascularity.

Start: September 2019

The Effect of Cyclosporin Before Cataract Surgery

To evaluate the effect of cyclosporine eye drop before cataract surgery for the prevention of post cataract surgery dry eye syndrome.

Start: June 2020

Clinical Efficacy of Intense Pulsed Light(IPL) Procedure in Dry Eye Patient

Clinical efficacy of Intense Pulsed Light(IPL) procedure in dry eye patients with meibomian gland dysfunction prior to cataract surgery.

Start: May 2020

Effect of Lipid Based Eye Drops on Tear Film Lipid Layer Thickness

Dry eye disease (DED) is a common ocular disease, especially in the elderly population. Despite many treatment approaches, instillation of topical lubricants remains the mainstay of therapy. However, most of the topical lubricants available are not very well characterised and data about efficacy is sparse. The aim of the present pilot study is to investigate the effect of topically administered lipid based eye drops on tear film lipid layer thickness in subjects with dry eye disease, Meibomian gland dysfunction, blepharospasm and healthy subjects. Tear film lipid layer and tear film thickness will be assessed using the Lipiview II interferometer and OCT. Measurements will be performed before instillation of the eye drops and every 10 minutes after instillation for one hour. One eye will receive lipid based eye drops, the other eye will receive no eye drops and will be used as control. The study eye will be chosen randomly. In addition, Dynamic Meibomian gland imaging, Schirmer I test, corneal fluorescein staining and determination of tear break up time (BUT) will be performed

Start: April 2017

Intense Pulsed Light in Meibomian Gland Dysfunctions

Dry eye disease (DED) is an extremely common disease whose meibomian gland dysfunction is the main etiology. Polychromatic intense pulsed light (IPL) is a promising new therapeutic alternative but few clinical data have been published. A new IPL device has recently been marketed: LACRYSTIM (QUANTEL, France). The investigators have been using it in our clinical practice since June 2019. The investigators present a retrospective study on our first clinical results.

Start: October 2019

Evaluating HA 0.15% Compared With Cyclosporine 0.05%, and Efficacy of Combination Therapy in Dry Eye Disease Patients

In patients with moderate to severe dry eye syndrome, the test drug (HA 0.15% eye drop) or the control drug (cyclosporin 0.05% eye drop) is administered for 12 weeks, and the corneal staining of each group would be evaluated. The study objective is to demonstrate that the test drug is not clinically inferior to the control drug. Furthermore, the efficacy of combination therapy would be evaluated through exploratory combination therapy group.

Start: November 2019

Assessment of TFT by OCT in Healthy Subjects and Subjects With DES

Dry eye syndrome (DES) is a highly prevalent ocular condition with potential severe consequences for affected patients. DES can be either caused by decreased tear production or increased tear evaporation, both leading to an instable tear film. Despite many efforts, generally accepted methodologies to diagnose, assess the severity and monitor DES are still lacking. Moreover, widely used clinical methods such as tear break up time (BUT), fluorescein staining of the cornea or Schirmer test only poorly reflect patients´ complains. One of the main problems in the diagnosis and treatment of DES is that the most critical component - the tear film itself - is difficult to characterize. The development of new ultra-high resolution optical coherence tomography systems allows now for the direct visualization of the human tear film and for the non-invasive in-vivo measurement of tear film thickness (TFT). The investigators could recently show that this system provides excellent reproducibility and is able to assess even subtle changes in TFT induced by therapeutic interventions. However, to which extent tear film thickness is associated with other standard clinical measures of DES is currently unknown. In the present study, the investigators set out to test the hypothesis that ocular TFT is a new and good surrogate parameter for the assessment of the severity of DES. Consequently, the aim of the study presented in this protocol is to investigate whether and if so, to what extent clinical signs of DES and reported symptoms are reflected in ocular TFT. For this purpose, a cross sectional study in healthy subjects and patients with DES will be performed. This should allow the investigators to more specifically characterize the role of the tear film in DES and to assess whether measurement of TFT with OCT can be a promising surrogate parameter for the diagnosis and the follow up of DES.

Start: August 2017

Effect of Topical Azithromycin on Tear Film Thickness in Patients With Meibomian Gland Dysfunction

Meibomian gland dysfunction (MGD) is among the leading causes for dry eye syndrome (DES), affecting millions of people worldwide. We have shown in a previous study that tear film thickness (TFT) is reduced in patients with DES and that this reduction correlates with tear break up time (BUT) as well as with the severity of subjective symptoms. Even though systemic tetracyclines as well as topical azithromycin can be used for the treatment of MGD, it seems that topical azithromycin is more effective than tetracyclines and also has the advantage of better tolerability. The hypothesis of the present study is that topical treatment with azithromycin leads to a more pronounced increase in TFT compared to oral doxycycline in patients with DES caused by MGD. The objective of this study is to compare the effect of treatment with topical azithromycin or oral doxycycline on tear film thickness in patients with DES caused by MGD.

Start: January 2018

Effect of Benzalkonium Chloride Containing Eye Drops on the Conjunctival Bacterial Flora of Dry Eye Patients

Benzalkonium chloride (BAC) is a preservative, which is a component of more than 70% of topical ophthalmic drugs. Although BAC is a preservative with an excellent antibacterial spectrum, it has also been shown to induce toxic effects to the ocular surface. Several studies have indicated that BAC may also have altering effects on the bacterial flora of the conjunctiva. Since dry eye syndrome (DES) is a very common and multifactorial disease of the ocular surface and the tear fluid resulting in tear film instability, inflammation of the ocular surface, symptoms of discomfort and visual impairment, there are many different preserved as well as preservative-free ophthalmic preparations of ocular lubricants for the treatment of DES. Unpublished data from our department shows differences between artificial tears for the treatment of DES with and without BAC in bacterial culture. Therefore, the aim of this study is to investigate the effect of artificial tear eyedrops with and without BAC on the conjunctival bacterial flora. For this 40 patients with mild or moderate dry eye syndrome with no use of artificial tears in the 4 weeks preceding the study will be recruited and treated either with the preservative-free "Prosicca sine" eyedrops or the BAC containing "Prosicca" eyedrops for one month. Conjunctival samples will be collected of one eye of each patient before and after the 1-month treatment period to compare the conjunctival bacterial flora of the two treatment groups.

Start: March 2020

Meibomian Gland Dysfunction Management With ZEST Protocol

The purpose of this study is to investigate if cleaning the eyelid margin with the ZEST protocol (Zocular Eyelid System Treatment) in patients intolerant to contact lens wear consequent to Meibomian gland dysfunction (MGD) will improve the MGD and contact lens wear comfort.

Start: June 2019

Diadenosine Polyphosphates and Mucin Associated With Ocular Surface Disorders

Dry eye disease, ocular graft-versus-host disease (GVHD), and superior limbic keratoconjunctivitis (SLK) are all ocular surface disorders which mostly involve the outer surface of the eye. Many of the ocular surface disorders may result from or be aggravated by the mechanical stress from eyelid blinking. Specifically, SLK is an inflammatory ocular surface disorder characterizing by redundant superior bulbar conjunctiva. Since redundant superior bulbar conjunctiva can cause a significant mechanical force during eyelid blinking, we found that conjunctival resection with Tenon's capsule excision is helpful in relieving the symptoms of SLK patients. Therapeutic contact lens, protecting the ocular surface from the microtrauma between eyelid and ocular surface, is also an effective treatment for severe dry eye disease, ocular GVHD, and SLK. Although shearing force/mechanical stress has been studied in many different tissues and disease entities, the impact of shearing force over ocular surface is still unclear. While the importance of mechanical stress in ocular surface disorder has been reported, the specific molecule involving the pathogenesis is still unknown. Diadenosine polyphosphates are a family of dinucleotides. They can enhance tear secretion and increase corneal wound healing rate from previous reports. Shear-stress stimuli was also noted to be able to induce diadenosine polyphosphates releasing from human corneal epithelium. In addition, mucin, one of the three components of tear film, has been greatly emphasized in the pathogenesis of dry eye disease. There are also some reports about the shearing force compensating the mucin contents in the inflammatory lung/bowel diseases. If diadenosine polyphosphates or mucin indeed play a role in mechanical stress-related ocular surface disorders, it will be a promising therapeutic targeting in the future.

Start: January 2018