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Glaucoma clinical trials

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NCT ID: NCT02594280 Not yet recruiting - Glaucoma Clinical Trials

Benchmarking Management of Glaucoma Using the Diopsys VEP/PERG Protocols.

Start date: February 15, 2018
Phase: N/A
Study type: Observational

Establish electrophysiological benchmarks, using the Diopsys Visual Evoked Potential/ Pattern ERG (VEP/PERG) protocols of populations with Glaucoma following: 1) Baseline VEP/ERG prior to treatment; and 2) VEP/PERG after treatment.

NCT ID: NCT02585375 Recruiting - Glaucoma Clinical Trials

Latanoprost Preserved Versus Unpreserved: Effect on Tear Film Thickness as Measured With OCT

Start date: September 17, 2015
Phase: Phase 4
Study type: Interventional

Topical antihypertensive eye drops are a key element of modern antiglaucoma treatment. Most of these eye drops contain preservatives to allow for the use of multi-dose containers. In the recent years evidence has, however, accumulated that these preservatives may induce ocular surface disease (OSD). This is particularly true for the most widely used preservative, benzalkonium chloride (BAK). Whereas this is well documented in many in vitro and animal studies, evidence from clinical trials is sparse. The only randomized masked study that showed superiority is a pivotal company-sponsored study indicating improved tolerability and reduced hyperemia of unpreserved versus preserved latanoprost eye drops. The investigators have recently introduced an optical coherence tomography (OCT) technology that provides a resolution as high as 1.2 µm for the human cornea. Using this technology the investigators were able to show that tear film thickness (TFT) is negatively correlated with symptoms of OSD. Changes in TFT can be assessed with very high sensitivity below the level of resolution as also evident from studies after administration of lubricants. In the present study, the investigators hypothesize that switching glaucoma patients from preserved prostaglandin analogues to unpreserved latanoprost is associated with an increase in TFT as measured with OCT. As a control the investigators will use preserved latanoprost and the study hypothesis will be tested in a randomized, controlled, single-masked parallel group design. TFT is chosen as main outcome variable, standard measures for signs and symptoms of OSD are selected as secondary outcomes. The present study may provide valuable information on the superiority of unpreserved versus preserved therapy.

NCT ID: NCT02571712 Completed - Ocular Hypertension Clinical Trials

Safety of GANFORT® Ophthalmic Solution in Chinese Patients With Open-angle Glaucoma or Ocular Hypertension

Start date: November 10, 2015
Phase: Phase 4
Study type: Interventional

A study to evaluate the long-term safety of GANFORT® (bimatoprost 0.03% plus timolol 0.5%) in Chinese patients with open-angle glaucoma or ocular hypertension who are insufficiently responsive to topical beta-blocker or prostaglandin analogues.

NCT ID: NCT02570867 Recruiting - Glaucoma Clinical Trials

Functional Brain Changes of Primary Open-angle Glaucoma Patients

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

Structural and functional brain changes of primary open-angle glaucoma patient will be examined with fMRI. POAG patients and control group were examined with 3.0T magnetic resonance imaging. The gray matter, white matter and cerebrospinal fluid volume images will be obtained and analysed.

NCT ID: NCT02565173 Completed - Clinical trials for Ocular Hypertension (OHT)

Study of Trabodenoson in Adults With Ocular Hypertension or Primary Open-angle Glaucoma

MATrX-1
Start date: September 2015
Phase: Phase 3
Study type: Interventional

Phase III trial involving topical application, in both eyes, of trabodenoson ophthalmic formulation 3.0% or 6.0% once per day or 4.5% twice per day, placebo twice per day, or timolol 0.5% twice per day for 12 weeks in adult subjects with Ocular Hypertension or Primary Open-Angle Glaucoma. All subjects who meet the study's enrollment criteria following Screening will undergo washout of all prohibited medications, including their routine glaucoma medications. During the Placebo Run-In Period, placebo is administered twice daily to both eyes in all subjects. During the Treatment Period, study drug is applied to both eyes for a total of 12 weeks followed by an Observation Period of approximately 7 days wherein no study eye drops are instilled. The purpose of the study is to assess the efficacy, tolerability, and safety of binocular topical application of trabodenoson ophthalmic formulation 3.0% or 6.0% QD or 4.5% BID for 12 weeks. Timolol is being included in the trial in order to have an active control to ensure the integrity of the trial from an efficacy perspective; the primary comparator for all statistical purposes is the placebo arm.

NCT ID: NCT02558712 Completed - Cataract Clinical Trials

Technology-based Eye Care Services (TECS) Compare

Start date: March 2016
Phase: N/A
Study type: Interventional

The purpose of this study is to compare the Technology-based Eye Care Services (TECS) protocol to the standard face to face ophthalmologic exam.

NCT ID: NCT02558400 Completed - Ocular Hypertension Clinical Trials

Double-masked Study of PG324 Ophthalmic Solution in Patients With Glaucoma or Ocular Hypertension

Start date: September 18, 2015
Phase: Phase 3
Study type: Interventional

To evaluate ocular hypotensive efficacy and safety of PG324 Ophthalmic Solution compared to Netarsudil (AR-13324) Ophthalmic Solution and Latanoprost Ophthalmic Solution. Following completion of the Month 12 study visit procedures, subjects will be offered the opportunity to participate in a 2-month observational (i.e., non-interventional) trial extension.

NCT ID: NCT02558374 Completed - Ocular Hypertension Clinical Trials

Double-masked Study of Netarsudil (AR-13324) Ophthalmic Solution in Subjects With Glaucoma or Ocular Hypertension

Start date: September 2015
Phase: Phase 3
Study type: Interventional

To evaluate ocular hypotensive efficacy and safety of Netarsudil (AR-13324) Ophthalmic Solution compared to Timolol Maleate Ophthalmic Solution.

NCT ID: NCT02554214 Recruiting - Glaucoma Clinical Trials

Pilot Clinical Trial on a New Adjustable Glaucoma Drainage Device

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

This will be a prospective, descriptive, mono-center, non-comparative study. A sample of 30 patients who satisfy entry criteria is estimated to be appropriate to provide safety and performance data for this study. The objectives of the study are to verify the performance and safety of the Glafkos adjustable glaucoma drainage device system. Performance will be measured assessing the possibility to adjust the intra-ocular pressure post-operatively. Safety will be measured by the incidence and severity of adverse events. The Glafkos device will be implanted in combination with a seton tube. The implant is placed under a scleral flap, in a manner analogous to the ex-Press device (Alcon). The distal end of the draining tube is linked to a seton draining tube, which is linked to a plate placed under the extraocular muscles, creating a filtering space at the orbit (filtering bleb).

NCT ID: NCT02548676 Completed - Glaucoma Clinical Trials

Optical Angiography in Glaucoma

Start date: September 11, 2015
Phase:
Study type: Observational

Glaucoma is one of the leading causes for blindness in industrialized countries. It is characterized by a progressive loss of retinal ganglion cells, morphological changes in the optic nerve head and a characteristic loss of visual field. It has been speculated for a long time that vascular factors may also contribute to the pathogenesis of the disease. This concept has been supported by several epidemiological studies showing that small retinal vessel calibre are associated with the disease. In the recent years tremendous enhancements in the field of optical coherence tomography has been achieved. These developments made it possible to visualize the retinal vasculature in a full depth manner without the application of an intravenous marker. The proposed study tests the hypothesis that patients with glaucoma show altered vascular morphology compared to healthy subjects. This is of importance because it may clarify the degree of vascular involvement in glaucoma.