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Epiphora clinical trials

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NCT ID: NCT02240615 Completed - Epiphora Clinical Trials

The Sinopsys Lacrimal Stent for Lacrimal System Repair in Epiphora

Start date: October 2014
Phase: Phase 0
Study type: Interventional

Prospective, open label, multi-center, non-randomized study designed to collect initial clinical data related to the safety and clinical performance of the Sinopsys Lacrimal Stent for use during repair of the lacrimal system in patients with functional or obstructive epiphora.

NCT ID: NCT01766232 Completed - Epiphora Clinical Trials

Lacrimal Drainage Resistance Study

LDRS
Start date: April 2009
Phase: N/A
Study type: Observational

Epiphora, or uncontrolled tearing of the eyes, represents a common presenting complaint of patients seen by ophthalmologists. Epiphora may be due to non-obstructive causes, such as tear hypersecretion or functional tear pump failure, or obstructive causes. Functional tear pump failure may result from malposition of the eyelids, such as an abnormal out-turning (ectropion) or in-turning (entropion) of the eyelid. Currently methods to diagnose partial nasolacrimal duct obstruction are purely qualitative in nature. Our research goal is to quantitatively measure the pressure generated during conventional probing and irrigation (P&I), and to measure the resistance to irrigation of the nasolacrimal drainage system. The investigators will measure the pressure generated during conventional P&I using a disposable in-line pressure transducer. In addition, the investigators will use a syringe pump to deliver a constant flow rate of saline through a nasolacrimal cannula and measure the steady state irrigation pressure using the in-line transducer and digital pressure monitor. Resistance can be directly calculated from the known flow rate and pressure measurements. The investigators will compare both the pressure generated during P&I and the lacrimal drainage resistance between patients with lacrimal drainage obstruction and controls patients with no obstruction (functional tear pump failure) as determined by clinical exam. Clinical applications for measuring lacrimal drainage resistance include quantifying partial nasolacrimal duct obstruction, guiding the choice of surgical procedure, and determining the success of lacrimal drainage procedures.

NCT ID: NCT01282541 Completed - Epiphora Clinical Trials

Determination of the Optimum Delivery Route for Botulinum Toxin A in Patients With Epiphora

Start date: February 2011
Phase: Phase 2
Study type: Interventional

Epiphora or excessive tearing is a significant disability for many affected patients diminishing their quality of life. There is a growing consensus that injection of Botulinum Toxin A (BTX-A) into the lacrimal gland provides relief in patients with hyperlacrimation secondary to aberrant regeneration of the 7th nerve, and limited evidence that it might help to reduce normal tear production in patients with epiphora from anatomic or functional outflow obstructions. BTX-A has been injected both transconjunctivally into the palpebral lobe of the lacrimal gland and transcutaneously into the orbital lobe. Both delivery routes have been successful in symptom relief with minimal complications. However, the effectiveness of transconjunctival versus transcutaneous injections has not been systematically compared. Also, whether the incidence of side effects is related to the dosage, concentration, or location of injection is unknown and has also not been systematically studied. The investigators plan to conduct a randomized clinical trial in patients with functional tearing comparing the transcutaneous delivery route of BTX-A to the transconjunctival delivery route (the most common route described in the literature). The investigators will also compare the side effect profile of each delivery route.

NCT ID: NCT01010659 Completed - Epiphora Clinical Trials

The Safety and Efficacy of Lacrimal Silicone Intubation for the Management of Epiphora

Start date: November 2009
Phase: Phase 4
Study type: Interventional

The purpose of study is to investigate the safety and efficacy of lacrimal silicone intubation for the management of epiphora.

NCT ID: NCT00824811 Withdrawn - Epiphora Clinical Trials

Topical Cyclosporine vs. Placebo for Epiphora Associated With Docetaxel

Start date: June 2009
Phase: Phase 2
Study type: Interventional

Objective: To evaluate the safety and efficacy of topical cyclosporine eye drops (Restasis®) for the treatment of epiphora caused by canalicular stenosis secondary to Docetaxel (Taxotere®) treatment for various cancers.

NCT ID: NCT00266838 Completed - Epiphora Clinical Trials

Prevention of Docetaxel Induced Dacryostenosis

Start date: July 2006
Phase: Phase 1
Study type: Interventional

The antineoplastic agent Docetaxel (Taxotere®) is approved for the treatment of patients with metastatic and locally advanced breast cancer and other malignancies. There are 2 frequently used schedules of treatment with Docetaxel. Docetaxel can be administered every 3 weeks or in a weekly regimen. The efficacy seems to be similar but the toxicity profile changes. In the standard 3-weekly Docetaxel regimen the dose-limiting side effect is myelosuppression, while in the weekly regimen there is only a mild myelosuppression. On the other hand, weekly Docetaxel has a side effect that is rare in the 3-weekly schedule: epiphora (= tearing eye) caused by dacryostenosis. The underlying mechanism of dacryostenosis induced by weekly Docetaxel is fibrosis of the lacrimal puncta and canaliculi. Docetaxel has been reported to be secreted in the lacrimal tears. Direct contact between Docetaxel containing tears and the epithelial lining causes chronic inflammation of the mucosa and ultimately fibrosis of the most narrow part of the lacrimal outflow system i.e. the lacrimal puncta and canaliculi. A surgical treatment is possible for dacryostenosis. In case of subtotal stenosis of the lacrimal canaliculi, silicone intubation of the canaliculi is performed in order to prevent further closure. In the case of complete stenosis, placement of a permanent pyrex glass tube of Jones is required. To our knowledge, there is no primary prevention for Docetaxel induced dacryostenosis. The rationale of this randomized double blind interventional study is to investigate the efficacy of corticosteroid versus artificial tears topical eye treatment in patients on a weekly Docetaxel regimen in prevention of dacryostenosis. The dacryotoxic agent Docetaxel in the lacrimal tears will be washed away by the repetitive use of eye drops. In addition, eye drops containing corticosteroids have an anti-inflammatory effect and may further prevent the formation of fibrosis. A new treatment protocol will be investigated. Two different commercially available eye drops will be compared: dexamethasone sodium phosphate (Maxidex®, Alcon) in one eye of the patient and artificial tears (Lacrystat®, Viatris) in the other eye of the same patient. The study period will start with topical eye treatment from day 1 of cycle 1 and will continue during the administration of chemotherapy, with a final analysis at 26 weeks.