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Dry Eye clinical trials

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NCT ID: NCT06013436 Completed - Dry Eye Clinical Trials

AST Combined With 0.05% Cyclosporin Eye Drop Improve Corneal Nerve Density in Patients With SS Dry Eye

AST/SS
Start date: June 1, 2022
Phase:
Study type: Observational

The objective of the present study was to evaluate the efficacy of autologous serum tears combined with 0.05% cyclosporin eye drop in treating Sjögren's syndrome dry eye and their effect on corneal nerves. We assessed the impact of 12-week AST combined with 0.05% cyclosporin eye drop treatment on signs, symptoms, and sub-basal nerve density (SND) in patients with dry eyes related to Sjogren's syndrome.

NCT ID: NCT05932225 Completed - Dry Eye Clinical Trials

Systane® Complete Preservative Free Lubricant Eye Drops

Start date: August 18, 2023
Phase: N/A
Study type: Interventional

The purpose of this post-market clinical follow-up (PMCF) study is to assess the performance and safety of Systane Complete Preservative Free (PF) Lubricant Eye Drops in subjects experiencing dry eye symptoms. Statistical analyses will be presented overall and by DED groups.

NCT ID: NCT05931861 Completed - Dry Eye Clinical Trials

Performance and Safety Assessment of T2769 in Contact Lens Wearers With Dry Eye Symptoms.

Start date: August 15, 2023
Phase: N/A
Study type: Interventional

This is a confirmatory clinical investigation. The objective is to collect new additional clinical data demonstrating the safety and performance of the device in the contact-lens wearing population with dry eyes. The hypotheses are that T2769 improves dry eye symptomatology (e.g. decrease in CLDEQ-8 score, in OSDI score, ocular discomfort assessed by VAS) and signs (e.g. increase in Schirmer and TBUT, decrease in Oxford score) at D36, in comparison to baseline. The primary objective of this investigation is to assess the performance of T2769 in contact lens wearers with dry eye symptoms in terms of change from baseline (Day 1) to Day 36 (Final visit) in Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8) total score.

NCT ID: NCT05918406 Completed - Dry Eye Clinical Trials

Phase 4 Study Evaluating the Safety of the Nasal Guide With Tyrvaya

Start date: June 14, 2023
Phase: Phase 4
Study type: Interventional

The objective of this study is to determine the safety of the nasal guide when utilized to aid in the administration of Tyrvaya (varenicline solution 0.03mg) Nasal Spray

NCT ID: NCT05911555 Completed - Dry Eye Clinical Trials

Mucin Levels in Dry Eye and Normal Populations

Start date: May 2013
Phase:
Study type: Observational

The purpose of this study is to evaluate changes in ocular mucin levels in response to a drying environment in subjects with dry eye disease as well as patients who report no history of dry eye disease. It is expected that exposure to the dry environment will alter mucin levels in different ways when comparing the two groups.

NCT ID: NCT05895500 Completed - Dry Eye Clinical Trials

Evaluate the Safety and Efficacy of Calcitonin Gene-Related Peptide (CGRP) Antagonists in Patients With Dry Eye Disease and Asthenopia

Start date: May 10, 2023
Phase:
Study type: Observational [Patient Registry]

Safety and Efficacy of Medications for Migraine in Patients with Dry Eye Disease or Asthenopia

NCT ID: NCT05859295 Completed - Dry Eye Clinical Trials

Evaluation of Low-Level Light Therapy on Meibomian Glands Study

ELOM
Start date: June 7, 2023
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to examine the effect of low-level light therapy (LLLT) on meibomian gland dysfunction and dry eye disease. The main questions it aims to answer are: 1. Does low-level light therapy reduce levels of pro-inflammatory proteins in meibum 2. Does low-level light therapy increase the ratio of non-polar lipids to polar lipids in meibum Participants will receive 3 15-minute sessions of low-level light therapy. Meibum will be collected before the first treatment and after the final treatment.

NCT ID: NCT05829499 Completed - Dry Eye Clinical Trials

PMCF Study to Evaluate Performance and Safety of "Xanoftal Next"

Start date: December 2, 2022
Phase: N/A
Study type: Interventional

Dry eye disease (DED), also called keratoconjunctivitis sicca, is a multifactorial disease of the ocular surface characterized by loss of homeostasis of the tear film and accompanied by symptoms such as ocular discomfort and visual disturbance. Patients with moderate-to-severe DED may experience a reduced quality of life due to ocular pain, difficulty in performing daily activities, and depression. Traditionally, dry eye syndrome and allergic conjunctivitis are regarded as 2 different diseases. However, recent literature has shown both conditions share similar characteristics, including several of their signs and symptoms (e.g. red, itchy, watery, and burning eyes). On the other hand, red swollen eyelids, burning sensations, ocular irritation, loss of eyelashes and misdirected eyelashes are also common symptoms of Blepharitis, an inflammatory disorder of eyelids affecting all the age and ethnic groups. First-line therapy for treating dry eye symptoms consists of over the counter (OTC) artificial tear drops, gels, ointments, or lubricants. Manufacturers have developed OTC products that appear to mimic the different layers of the tear film in order to maintain ocular hydration. For these reasons, an interventional, non-comparative, Post Marketing Clinical Follow-up (PMCF) study was planned to evaluate the performance and safety of "Xanoftal Next" used to attenuate symptoms of seasonal allergic conjunctivitis, even when associated with dry eye syndrome. The objectives of the PMCF study are confirmation of the performance, collection of additional safety data regarding expected adverse events and detection of potential unexpected adverse events associated with use of "Xanoftal Next" according to the Instructions for Use (IFU). Each subject, after signing the Informed Consent Form, will enter the screening and baseline phase (the 2 visits will coincide) during which baseline procedures will be completed. At baseline visit, the "Xanoftal Next" product will be administered to the enrolled subject. The patient will perform 2 on-site visits: V0 and V2/EOS. To monitor the safety, 1 phone contact is planned (V1) to check for potential adverse events and concomitant medications intake.

NCT ID: NCT05825599 Completed - Dry Eye Clinical Trials

PMCF Study to Evaluate Performance and Safety of "HPMC-based Eyedrops" Used to Relieve Dry Eye Symptoms

Start date: September 6, 2022
Phase: N/A
Study type: Interventional

Dry eye disease (DED), also called keratoconjunctivitis sicca, is a common ocular condition characterized by a loss of homeostasis of the tear film and inflammation of the ocular surface. Over the counter (OTC) artificial tears are typically the first line of dry eye treatment; they are meant to supplement the tears that cover the eye's surface. OTC products mimic the different layers of the tear film in order to maintain ocular hydration. Hydroxypropyl methylcellulose (HPMC or hypromellose) is a synthetic modification of the natural polymer, cellulose. It has been widely used in in ophthalmologic formulations such as eye drops and gels due to its solubility in water, biocompatibility, transparency and rheological properties. Eye drops containing HPMC are conventionally used to treat tear film disturbances including dry eye symptoms. For these reasons, an interventional, non-comparative, single-center Post Marketing Clinical Follow-up (PMCF) study was planned to evaluate the performance and safety of "Hydroxypropyl methylcellulose (HPMC)-based eyedrops" used as intended to relieve dry eye symptoms. The objectives of the PMCF study are confirmation of the performance, collection of additional safety data regarding expected adverse events and detection of potential unexpected adverse events associated with use of "HPMC-based eyedrops" according to the Instructions for Use (IFU). "HPMC-based eyedrops" medical devices are ophthalmic solutions containing hydroxypropyl methylcellulose (HPMC) as key ingredient, a polymer able to relief eye discomfort thanks to its moisturizing, lubricating and muco-mimetic properties. HPMC can stabilize the tear film on the ocular surface by creating a protective, transparent and viscoelastic shield. Each subject, after signing the Informed Consent Form (ICF), will enter the screening and baseline phase (the 2 visits will coincide) during which baseline procedures will be completed. At baseline visit (V0), only one of the below reported "HPMC-based eyedrops" products will be administered to the enrolled subject. The patient will perform 2 on-site visits: V0 and V2/EOS. To monitor the safety, 1 phone contact is planned (V1) to check for potential adverse events and concomitant medications intake.

NCT ID: NCT05825586 Completed - Dry Eye Clinical Trials

PMCF Study to Evaluate Performance and Safety of "Distilled Waters-based Eyedrops" Used to Relieve Dry Eye Symptoms

Start date: August 2, 2022
Phase: N/A
Study type: Interventional

Dry eye disease (DED), also called keratoconjunctivitis sicca, is a common ocular condition characterized by a loss of homeostasis of the tear film and inflammation of the ocular surface. The typical symptoms of DED include irritation, discomfort, blurred or fluctuating vision. Over the counter (OTC) artificial tears are typically the first line of dry eye treatment; they are meant to supplement the tears that cover the eye's surface. OTC products mimic the different layers of the tear film in order to maintain ocular hydration. Distilled waters of natural herbs such as Green Tea, Calendula, Chamomile, Hamamelis and Euphrasia are known for their soothing and refreshing properties. Thanks to the combined action of these natural elements, distilled waters-based eyedrops are particularly indicated to relieve eye dryness, irritation and redness of the eyes' mucosa caused by atmospheric agents, environmental factors, and/or use of contact lenses. "Distilled waters-based eyedrops" medical devices are ophthalmic solutions containing distilled waters able to relieve eye discomfort thanks to their soothing and refreshing action. For these reasons, an interventional, non-comparative, single-center Post Marketing Clinical Follow-up (PMCF) study was planned to evaluate the performance and safety of "Distilled waters-based eyedrops" used as intended to relieve dry eye symptoms. The objectives of the PMCF study are confirmation of the performance, collection of additional safety data regarding expected adverse events and detection of potential unexpected adverse events associated with use of "Distilled waters-based eyedrops" according to the IFU. Each subject, after signing the Informed Consent Form, will enter the screening and baseline phase (the 2 visits will coincide) during which baseline procedures will be completed. At baseline visit (V0), one of the "Distilled waters-based eyedrops" products will be administered to the enrolled subject. The patient will perform 2 on site visits (V0 and V2/EOS). To monitor the safety, 1 phone contact is planned (V1) to check for potential adverse events and concomitant medications intake. The first administration and the intervals at which the treatment should be repeated, to be done as per Investigator judgment and according to the IFU, depend on various factors regarding the physiology of the patients (e.g. type of eye-tear film, anatomy, age), their lifestyle (e.g. use of computer, wearing of contact lenses).