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Keratoconjunctivitis Sicca clinical trials

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NCT ID: NCT02595606 Recruiting - Diabetes Mellitus Clinical Trials

0.3% Sodium Hyaluronate in the Treatment of Dry Eye of Diabetic Patients

Start date: September 2015
Phase: Phase 4
Study type: Interventional

A randomized parallel controlled study was designed to compare the efficacy of 0.3% Sodium Hyaluronate in the treatment of Dry Eye of diabetic patients.

NCT ID: NCT02585414 Recruiting - Dry Eye Syndromes Clinical Trials

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

Start date: August 31, 2017
Phase:
Study type: Observational

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.

NCT ID: NCT02533154 Recruiting - Dry Eye Syndromes Clinical Trials

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

Start date: July 27, 2015
Phase: Phase 4
Study type: Interventional

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.

NCT ID: NCT02306668 Recruiting - Dry Eyes Clinical Trials

Ocular Surface Dry Eye Microbiome

Start date: February 2014
Phase: N/A
Study type: Observational

The investigators seek to characterize the identity of all microorganisms residing on the eye's surface (conjunctiva) in healthy eyes and those with dry eye syndrome, using a combination of analyses. Dry eye disease is thought to have an inflammatory basis and in the vast majority of cases the cause of the chronic inflammatory condition is unknown.

NCT ID: NCT02106377 Recruiting - Dry Eye Syndrome Clinical Trials

Using in Vivo Confocal Microscopy to Assess Cellular Response and Efficacy of Steroid Treatment in Dry Eye Disease

Start date: February 2014
Phase: N/A
Study type: Interventional

Current steroid therapy in dry eye disease (DED) is comprised of a 2 week duration of pulse therapy, administered twice daily (to avoid adverse effects associated with long-term steroid use). This timeframe is often too short to meaningfully resolve the inflammation associated with DED. Thus, corneal specialists, including here at MEEI, have begun using steroid treatment of at least 6 weeks with tapered dosing. In vivo confocal microscopy (IVCM) is a novel imaging technology that allows the visualization and quantification of certain corneal features associated with DED, such as hyperfluorescent superficial epithelial cells, immune dendritic cells, and sub-basal nerves. Recent cross-sectional studies have begun to shed light on the correlation of these features with traditional outcome measures typically assessed in DED, such as corneal and conjunctival staining, Schirmer's testing, tear break-up time (TBUT), and symptom questionnaires. However, longitudinal studies using IVCM to demonstrate how steroid treatment affects the corneal epithelial cells, dendritic cells and nerves are largely lacking. Furthermore, studies on the safety and efficacy of a 6 week tapered dosing steroid regimen are also lacking.

NCT ID: NCT02066896 Recruiting - XEROSTOMIA Clinical Trials

Laser Therapy to Treat the Dry Mouth of Sjogren's Syndrome

Start date: May 2014
Phase: Phase 3
Study type: Interventional

This study was designed to test the efficacy and safety of low laser therapy to treat the xerostomia of patients with primary Sjogren's Syndrome.

NCT ID: NCT01561040 Recruiting - Dry Eye Syndrome Clinical Trials

Oral Nutrition Impact on Tear Film

ONIT
Start date: March 2012
Phase: Phase 4
Study type: Interventional

Dry eye disease (DED) is a common but often inadequately treated disease of the tears and surface of the eye. It can cause poor vision and chronic pain and is more frequent with increasing age. The 1995 Report of the National Eye Institute/Industry Workshop on Clinical Trials in Dry Eye defined dry eye as "a disorder of the tear film due to tear deficiency or excessive evaporation, which causes damage to the interpalpebral ocular surface and is associated with symptoms of ocular discomfort". The International Dry Eye Work Shop (DEWS) committee subsequently defined dry eye as "a multi-factorial disease of the tears and ocular surface that results in symptoms of discomfort, visual disturbance, and tear film instability with potential damage to the ocular surface. It is accompanied by increased osmolarity of the tear film and inflammation of the ocular surface." Typically, symptoms associated with dry eye disease include ocular burning, foreign body sensation (sand or grit), photophobia (light sensitivity), and other symptoms that result in overall long term discomfort in patients. The proposed eight week feasibility study if dry eye subjects confirmed elevated osmolarity and symptoms respond to nutritional therapy.

NCT ID: NCT01441895 Recruiting - Cataract Clinical Trials

Corneal Sensation and Incidence of Dry Eye Post Refractive Cataract Extraction With FemtoSecond Laser

Start date: September 2011
Phase: N/A
Study type: Observational

The study objective is to assess changes in corneal sensation and dry eye signs and symptoms following cataract extraction/femtosecond arcuate relaxing incisions. Our clinical hypothesis is to determine if a combination of cataract surgery and femtosecond arcuate relaxing incisions lead to a reduction in corneal sensation and the onset or worsening of dry eye signs and symptoms.

NCT ID: NCT01386073 Recruiting - Dry Eye Clinical Trials

Efficacy of FreshKote and Systane for the Treatment of Dry Eye and Improvement of Osmolarity

Start date: July 2011
Phase: Phase 4
Study type: Interventional

The purpose of this study is to compare the efficacy of FreshKote and Systane for the reduction of dry eye signs and symptoms.

NCT ID: NCT01382810 Recruiting - Dry Eye Syndromes Clinical Trials

Altaire Gel Forming Solution Versus Refresh Tears for the Treatment of Dry Eye Signs and Symptoms

Start date: March 2011
Phase: Phase 4
Study type: Interventional

The purpose of this study is to evaluate and compare the effects of Altaire Gel forming solution and Refresh Tears in mild-moderate dry eye patients.