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Sjogren's Syndrome clinical trials

View clinical trials related to Sjogren's Syndrome.

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NCT ID: NCT04835623 Completed - Dry Eye Clinical Trials

CEQUA for Sjogren's Syndrome Dry Eye

Start date: June 21, 2021
Phase: Phase 4
Study type: Interventional

The primary objective of this study is to show that CEQUA (cyclosporine 0.09% ophthalmic solution) improves symptoms of dry eye disease in a population of patients with Sjogren's Syndrome diagnosis.

NCT ID: NCT04819269 Completed - Dry Eye Disease Clinical Trials

Tivanisiran for Dry Eye in Subjects With Sjögren's Syndrome

Start date: May 25, 2021
Phase: Phase 3
Study type: Interventional

This study will examine the efficacy and safety of tivanisiran sodium eye drops versus vehicle after a 2-week run-in phase when dosed once daily for 3 months in subjects with signs and symptoms of dry eye disease (DED) due to Sjögren's Syndrome.

NCT ID: NCT04816370 Completed - Clinical trials for Primary Sjögren Syndrome

Effects of Primary Sjögren's Syndrome on Female Genitalia and Sexual Functions

Start date: July 2, 2015
Phase: N/A
Study type: Interventional

A total of 68 women with pSS and 135 healthy female patients were included in the study. All women in the study and control groups were evaluated gynecologically, and genital findings during the examination and variables related to pSS were recorded. Women's sexual functions were evaluated with the Female Sexual Function Index (FSFI) and quality of life was evaluated using the Health Status Questionnaire-Short Form 36.

NCT ID: NCT04802577 Completed - Depression Clinical Trials

Fatigue in Primary Sjögren's Syndrome

Start date: January 4, 2021
Phase:
Study type: Observational [Patient Registry]

Fatigue is a common clinical finding in Primary Sjögren's syndrome (PSS). In PSS, there is not enough data about the conditions in which fatigue develops and which clinical conditions the disease is associated with. This study was aimed to determine the level of fatigue in Primary Sjögren syndrome and to investigate the factors affecting the level of fatigue.

NCT ID: NCT04798911 Completed - Sjögren's Syndrome Clinical Trials

SS-INQ Information Needs Questionnaire in Sjögren's Syndrome

SS-INQ
Start date: October 12, 2018
Phase:
Study type: Observational

Patients with some long-standing rheumatic diseases have stated that they want to be fully informed about their disease as they find it 'more scary not to know' about possible complications and consequences. Patients who have the information they want about their disease can fully take part in decisions about their own health creating a partnership with their doctor. Sjögren's Syndrome (SS) is a multi-system, long-standing rheumatic disease that has a negative impact on the daily life of patients. A common presentation of this disease is dry mouth, which can make talking, eating and swallowing more difficult. Project aims: We aim to ask patients with SS what information they think it would be important to know about SS. We plan to create a questionnaire that can be used by doctors to help deliver the right information to patients at hospital visits. Timescale: This project will take 36 months to complete. Clinical relevance: This questionnaire could be used in daily practice. It could help patients cope with their disease, take part in treatment decision and reduced uncertainty and distress.

NCT ID: NCT04649177 Completed - Dry Eye Syndromes Clinical Trials

Pilot Study to Investigate the Feasibility, Reliability and Efficacy of Utilizing OCT to Automate PROSE Fitting

Start date: December 15, 2020
Phase: N/A
Study type: Interventional

EYEdeal Scanning Technology enables rapid measurement of corneal and scleral topography. By accurately measuring the ocular surface with this imaging technology, the current iterative fitting method required to fit PROSE (prosthetic replacement of the ocular surface ecosystem) devices could be replaced and/or strengthened with a more rapid, automated fitting sequence. This could considerably reduce the time needed per visit, the number of visits, and the number of devices needed to be manufactured to reach the endpoint. Additionally, the scanning technology may afford the opportunity to successfully fit some pathology that were previously treatment failures. The automated technology may as well reduce the intensive clinician training time needed to fit PROSE devices, therefore increasing the availability and access to patients. The goal of this research is to evaluate the reliability and efficacy of this automated technology for fitting PROSE devices. Data from real-time measurement of the human eye ocular surface topography will be used to fabricate a prosthetic lens. The fit of the PROSE device will be evaluated, as well as the subjective comfort of the fit.

NCT ID: NCT04615455 Completed - Clinical trials for Keratoconjunctivitis Sicca, in Sjogren's Syndrome

Mesenchymal Stem Cell Therapy of Dry Eye Disease in Patients With Sjögren's Syndrome

AMASS
Start date: November 3, 2020
Phase: Phase 2
Study type: Interventional

AMASS is a double-blinded randomized clinical trial with the purpose of investigating whether injection of allogeneic adipose-derived mesenchymal stem cells (ASCs) into the lacrimal gland (LG) results in increased ocular comfort compared to placebo.

NCT ID: NCT04605978 Completed - Clinical trials for Primary Sjögren's Syndrome

Efficacy and Safety of S95011 in Primary Sjögren's Syndrome Patients

Start date: August 3, 2021
Phase: Phase 2
Study type: Interventional

The purpose of this study is to assess the effect of multiple intravenous infusions of S95011 compared to placebo in reducing disease activity in patients with primary Sjögren's syndrome.

NCT ID: NCT04597762 Completed - Dry Eye Syndromes Clinical Trials

Effect of Ciclosporin Eyedrops on Sjögren Syndrome

Start date: August 31, 2020
Phase: N/A
Study type: Interventional

Keratoconjunctivitis sicca, also known as dry eye syndrome, is one of the most common ophthalmological diseases and is treated with tear substitutes to moisten the surface of the eye and, in more severe cases of this disease, with local anti-inflammatory therapy with corticosteroids or ciclosporin A. In patients with rheumatological diseases, such as Sjögren's syndrome, dry eye syndrome of severe extent occurs particularly frequently, which is why topical anti-inflammatory therapy is often necessary in these patients. Aim of this study is to evaluate the treatment of severe dry eye syndrome with topical cyclosporin eyedrops with and without topical corticosteroids at the beginning of the treatment.

NCT ID: NCT04572841 Completed - Sjogren's Syndrome Clinical Trials

Safety, Tolerability, Pharmacokinetics, and Therapeutic Efficacy of SAR441344 in Primary Sjögren's Syndrome (pSjS)

phaethuSA
Start date: November 12, 2020
Phase: Phase 2
Study type: Interventional

Primary Objective: To evaluate the therapeutic efficacy of one dose level of SAR441344 versus placebo over 12 weeks in adult patients with primary Sjögren's syndrome (pSjS), assessed by the change of the European League Against Rheumatism (EULAR) Sjögren's Syndrome Disease Activity Index (ESSDAI) Secondary Objectives: - To evaluate the therapeutic efficacy of one dose level of SAR441344 versus placebo over 12 weeks in adult patients with pSjS - To evaluate the therapeutic efficacy on fatigue of one dose level of SAR441344 versus placebo over 12 weeks in adult patients with pSjS - To evaluate the pharmacokinetic (PK) exposure of one dose level of SAR441344 over 12 weeks in adult patients with pSjS - To evaluate the safety and tolerability of one dose level of SAR441344 versus placebo in adult patients with pSjS as determined by adverse events (AEs) - To evaluate the local tolerability of one dose level of SAR441344 versus placebo over 12 weeks in adult patients with pSjS - To evaluate the safety and tolerability of one dose level of SAR441344 versus placebo over 12 weeks in adult patients with pSjS determined by electrocardiogram, vital signs, and laboratory evaluations - To measure the immunogenicity of one dose level of SAR441344 versus placebo over 12 weeks in adult patients with pSjS This is a multicenter, randomized, double blind, placebo controlled, parallel group proof of concept Phase 2 study to evaluate the therapeutic efficacy of SAR441344 in adult patients with primary Sjögren's syndrome (pSjS), as well as safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD). - Study visit frequency: every 2 weeks in the treatment period and every 4 weeks in the follow-up period. - The total duration of the study will be 24 weeks (28 weeks including maximum screening duration) for each participant, including a 12-week treatment period and a 12-week follow-up period.