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Eye Diseases clinical trials

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NCT ID: NCT05807360 Completed - Dry Eye Clinical Trials

PMCF Study to Evaluate Performance and Safety of "Hyaluronic Acid (HA)-Based Eyedrops" Used to Relieve Dry Eye Symptoms

Start date: June 24, 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. HA is found in higher concentrations in the vitreous humor of the eye, cartilage, and the synovial fluid. As a component of the tear film, HA increases the viscosity of the tear film and hydrates and lubricates the ocular surface. HA possesses intrinsic water retention properties, viscoelasticity, and favors the healing of corneal and conjunctival epithelium. 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 "HA-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 "HA-based eyedrops" according to the IFU. "Hyaluronic Acid (HA)-based eyedrops" are medical devices used as intended to improve the discomfort due to dry eye (for intrinsic and/or extrinsic causes), contact lenses wearing and/or eye surgery. 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 "Hyaluronic Acid (HA)-based eyedrops" products can be dispensed to the enrolled Subjects, depending on Investigator clinical evaluation, and severity of the disease. 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 (AEs) and concomitant medications intake.

NCT ID: NCT05795621 Completed - Thyroid Eye Disease Clinical Trials

A Study of IBI311 in Subjects With Active Thyroid Eye Disease

Start date: February 14, 2023
Phase: Phase 2/Phase 3
Study type: Interventional

This is a multicenter, randomized, double-masked, placebo-controlled Phase II/III study in subjects with active thyroid eye disease. Approximately 114 subjects meeting study eligibility criteria will be randomly assigned to IBI311 or placebo on day 1 (D1) in a 2:1 ratio stratified by smoking status

NCT ID: NCT05793359 Completed - Clinical trials for Graves Ophthalmopathy

Comparison of the Effectiveness of Two Glucocorticoid Regimens for Treatment of Graves' Orbitopathy

Start date: July 25, 2017
Phase:
Study type: Observational [Patient Registry]

The goal of this interventional study is to compare the effectiveness of two different glucocorticoid regimens for treatment of active moderate-to-severe Graves' orbitopathy. The main questions it aims to answer are: 1. Are the two glucocorticoid regimens similarly effective? 2. Do the two glucocorticoid regimens have similar safety profile? The patients involved are treated with one of the two glucocorticoid regimens. Their ocular status, therapeutic response and quality of life reassessed during the treatment, at its end, and 3 month later.

NCT ID: NCT05775185 Completed - Clinical trials for Graves Ophthalmopathy

Therapeutic Efficacy of Orbital Radiotherapy in Patients With Graves' Orbitopathy

Start date: July 25, 2017
Phase:
Study type: Observational [Patient Registry]

The purpose of the present interventional study is to assess the changes in the therapeutic response, ocular manifestations of Graves' orbitopathy and quality of life during the first year after orbital radiotherapy. The main questions it aim to answer are: 1. How effective is orbital radiotherapy used as first- or second-line treatment in patients with Graves' orbitopathy? 2. How does the quality of life changes after orbital radiotherapy? Participants have active moderate-to-severe Graves' orbitopathy and are treated with low dose fractionated orbital radiotherapy for two weeks. During the follow-up period they undergo regular ocular examinations and fill out a disease-specific questionnaire.

NCT ID: NCT05759208 Completed - Dry Eye Disease Clinical Trials

The Study Evaluating the Efficacy and Safety of OK-101 in Subjects With Dry Eye Disease

Start date: April 28, 2023
Phase: Phase 2
Study type: Interventional

The objective of this study is to compare the safety and efficacy of OK-101 Ophthalmic Solution to placebo for the treatment of the signs and symptoms of dry eye.

NCT ID: NCT05753189 Completed - Presbyopia Clinical Trials

Phase 3 Safety Study for the Treatment of Presbyopia Subjects

Start date: February 21, 2023
Phase: Phase 3
Study type: Interventional

Safety Study of the Long-Term Safety of LNZ101 in Presbyopic Subjects

NCT ID: NCT05745064 Completed - Dry Eye Disease Clinical Trials

A Study of TL-925 as a Treatment for Dry Eye Disease

Start date: February 27, 2023
Phase: Phase 2
Study type: Interventional

In this prospective, Phase 2, multicenter, randomized, double-masked, placebo-controlled, parallel-arm study, approximately 100 subjects with moderate to severe dry eye disease (DED) will be randomly assigned (1:1) to receive either TL-925 or placebo as topical ophthalmic eye drops administered bilaterally BID. The study will comprise two phases: 2-weeks screening/run-in and 4-weeks double-masked treatment.

NCT ID: NCT05743764 Completed - Dry Eye Disease Clinical Trials

HU007 in Patients With Dry Eye Syndrome

Start date: March 23, 2023
Phase: Phase 3
Study type: Interventional

A multicenter, Randomized, Double blind, Restasis®-controlled Non-inferiority, Moisview® Eye Drops Controlled Superiority, Phase III Study to Evaluate the Efficacy and Safety of HU007 Eye Drops in Patients with Dry Eye Syndrome

NCT ID: NCT05731154 Completed - Thyroid Eye Disease Clinical Trials

Development of an AI Solution to Evaluate Clinical Activity of TAO Using Periocular Images Taken by Smartphones in Patients With Thyroid Dysfunction

Start date: December 22, 2021
Phase:
Study type: Observational

This study was conducted to develop an AI solution to evaluate clinical activity score (CAS) of thyroid associated orbitopathy (TAO) using periocular selfie images taken by smartphones in patients with thyroid dysfunction. An AI solution to evaluate CAS in TAO was developed in previous retrospective study using periorbital digital images taken by DSLR camera in the studio. This AI solution will be adjusted to show its best performance with periocular selfie images taken by smartphones.

NCT ID: NCT05728944 Completed - Presbyopia Clinical Trials

Phase 3 Efficacy Study of LNZ101 for the Treatment of Presbyopia

CLARITY
Start date: April 24, 2023
Phase: Phase 3
Study type: Interventional

Phase 3 Efficacy Study to evaluate the Safety and Efficacy of LNZ101 for the Treatment of Presbyopia