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

Status Recruiting

Clinical Trial Summary

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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02585414
Study type	Observational
Source	Medical University of Vienna
Contact	Gerhard Garhofer, MD
Phone	+43 1 40400
Email	gerhard.garhoefer@meduniwien.ac.at
Status	Recruiting
Phase
Start date	August 31, 2017
Completion date	December 2023

View Details

See also
Status	Clinical Trial	Phase
Active, not recruiting	`NCT04425551` - Effect of Micropulse Laser on Dry Eye Disease Due to Meibomian Gland Dysfunction	N/A
Not yet recruiting	`NCT06379685` - Study to Evaluate the Safety and Tolerability of PRO-190 Ophthalmic Solution Compared to Systane Ultra® on the Ocular Surface.	Phase 1
Recruiting	`NCT04701086` - 3 Month Study of Cationorm Pro Versus Vismed in Adults With Dry Eye Disease Related to Keratitis or Keratoconjunctivitis	N/A
Active, not recruiting	`NCT03697876` - Safety and Tolerability of the Ophthalmic Gel PRO-165 Versus Artelac® Nightime Gel	Phase 1
Completed	`NCT02910713` - Evaluation of Dry Eye Symptoms in CAE With Application of Intranasal Neurostimulation	N/A
Terminated	`NCT02815293` - Topical Ophthalmic AGN-195263 for the Treatment of Evaporative Dry Eye	Phase 3
Completed	`NCT04104997` - A Clinical Trial to Evaluate the Safety, Tolerability and Pharmacokinetic Characteristics of GLH8NDE After Single and Mutiple Ocular Administrations in Healthy Korean and Caucasian Volunteers	Phase 1
Recruiting	`NCT02595606` - 0.3% Sodium Hyaluronate in the Treatment of Dry Eye of Diabetic Patients	Phase 4
Completed	`NCT01711424` - An Observational Study of OPTIVE PLUS® for the Treatment of Dry Eye Disease	N/A
Completed	`NCT01202747` - Evaluation of Screening Methods for Treatment of Meibomian Gland Dysfunction	Phase 2/Phase 3
Completed	`NCT01015209` - Safety and Tolerability of Chitosan-N-acetylcysteine Eye Drops in Healthy Young Volunteers	Phase 1
Completed	`NCT00969280` - Acupuncture for Dry Eye Syndrome	Phase 3
Completed	`NCT00739713` - Effects of Sea Buckthorn Oil on Dry Eye	N/A
Completed	`NCT01496482` - Comparison of Evaporimetry With the Established Methods of Tear Film Measurement	N/A
Completed	`NCT00756678` - Efficacy and Acceptability of Two Lubricant Eye Drops	Phase 4
Completed	`NCT00370747` - Efficacy and Safety Study for Ecabet Ophthalmic Solution for Treating Dry Eye Syndrome	Phase 2
Completed	`NCT00349440` - Efficacy of Cyclosporine for the Prevention and Treatment of Dry Eye Symptoms Following LASIK or Photorefractive Keratectomy	Phase 4
Completed	`NCT05162261` - to Evaluate the Effectiveness and Safety of the Tixel® , VS LipiFlow® in the Treatment of Meibomian Gland Dysfunction	N/A
Completed	`NCT02871440` - A Two Comparator, Controlled Phase 3 Study in Patients With and Without Evaporative Dry Eye	Phase 3
Completed	`NCT05042960` - Computer Screen Properties Study	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms