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Keratoconjunctivitis Sicca clinical trials

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NCT ID: NCT02585453 Completed - Dry Eye Syndromes Clinical Trials

Influence of Lachrymal Substitute Gels on Tear Film Thickness in Patients With Moderate to Severe Dry Eye Syndrome

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

Dry eye syndrome is a highly prevalent ocular disease with an increasing incidence in the elderly population. Topically administered lubricants are the basis for treatment of this disease. However, exact information about the tear film thickness and the corneal residence time of topical lubricants is still sparse, therefore no ideal treatment regimen has been found. Recently a new method for assessment of tear film thickness based on ultra high resolution optical coherence tomography (OCT) has become available. The aim of the present study is to assess tear film thickness and corneal residence time of three different formulations of topical lubricants, in particular Thealoz Duo® Eye Drops, Hylo® Gel Eye Drops and Systane® Gel Eye Drops in patients with moderate to severe dry eye disease. In addition, standard tests for dry eye syndrome, such as the ocular surface disease index (OSDI©), Schirmer I test and determination of tear break up time (BUT) will be performed.

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: NCT02554981 Completed - Dry Eye Syndromes Clinical Trials

Evaluation of Maintaining Visual Performance in Participants Who Engage in Electronic Visual Tasking While Using Restasis®

EMPOWER
Start date: July 21, 2015
Phase: Phase 4
Study type: Interventional

This study will evaluate the efficacy of Restasis® in participants with dry eye disease who engage in electronic visual tasking.

NCT ID: NCT02553772 Completed - Dry Eye Syndromes Clinical Trials

A Safety and Efficacy Study of a New Eye Drop Formulation in Patients With Dry Eye Disease.

Start date: January 6, 2016
Phase: Phase 3
Study type: Interventional

This study will evaluate the safety and efficacy of a new eye drop formulation in patients with dry eye disease.

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: NCT02526290 Completed - Dry Eye Syndromes Clinical Trials

Six Month Study to Evaluate the Safety and Effectiveness of the Intranasal Lacrimal Neurostimulator

Start date: August 31, 2015
Phase: N/A
Study type: Interventional

In this study, the safety and effectiveness of the Oculeve Intranasal Lacrimal Neurostimulator after 180 days of use in participants with aqueous tear deficiency will be evaluated.

NCT ID: NCT02522312 Completed - Dry Eye Syndrome Clinical Trials

A Retrospective Analysis of Restasis® Benefits in Dry Eye Contact Lens Patients

Start date: September 2015
Phase: N/A
Study type: Observational

A retrospective analysis of Restasis® benefits in dry eye contact lens patients.

NCT ID: NCT02511379 Terminated - Dry Eye Clinical Trials

Clinical Evaluation of Systane® Balance in Dry Eye Subjects

Start date: November 26, 2015
Phase: N/A
Study type: Interventional

The purpose of this study is to evaluate the efficacy and safety of Systane® Balance following 90 days of QID (4 times/day) dosing among Indian subjects with dry eye.

NCT ID: NCT02510235 Completed - Dry Eye Syndrome Clinical Trials

Tolerability, Safety and Efficacy of Lubricin Eye Drops vs Sodium Hyaluronate Eye Drops in Subjects With Mod. Dry Eye

Start date: March 2015
Phase: N/A
Study type: Interventional

Dry eye is a multifactorial 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. Lubricin is a mucin-like glycoprotein originally discovered in synovial fluid, as a secreted product of cells that line the joint tissues, which is present at the surface of articular cartilage and it has been investigated on its roles at the ocular surface, in normal and pathologic conditions such as dry eye. The objective of the study is to assess the tolerability, safety and efficacy of Lubricin eye drops solution administered over 4 weeks versus sodium hyaluronate (Na-HY) eye drops solution in subjects with moderate dry eye.

NCT ID: NCT02507934 Completed - Dry Eye Syndrome Clinical Trials

Tolerability, Safety and Efficacy of Lubricin (150 µg/ml) Eye Drops Versus Sodium Hyaluronate (HA) 0.18% Eye Drops in Patients With Moderate Dry Eye (DE)

Start date: June 2015
Phase: N/A
Study type: Interventional

Dry eye is a multifactorial 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. Lubricin is a mucin-like glycoprotein originally discovered in synovial fluid, as a secreted product of cells that line the joint tissues, which is present at the surface of articular cartilage and it has been investigated on its roles at the ocular surface, in normal and pathologic conditions such as dry eye. The objective of the study is to assess the tolerability, safety and efficacy of Lubricin eye drops solution administered over 4 weeks versus sodium hyaluronate (Na-HY) eye drops solution in subjects with moderate dry eye.