Clinical Research Directory

Association Between Periodontitis and Dry Eye Disease: A Cross-Sectional Study

This study is aiming at exploring the association between periodontitis and dry eye disease, which are both chronic inflammatory diseases that might have common pathogenic mechanisms. It is a cross-sectional study being conducted on four specific groups: a healthy group, periodontitis only, dry eye disease only, and a group with both periodontitis and dry eye disease. For all individuals, both clinical periodontal and ophthalmic parameters and assessments are being recorded. The study also includes collection of both saliva and tear samples from all individuals for later analysis of inflammatory biomarkers. Saliva samples will be collected using the drooling method, while tear samples will be collected using Schirmer strips. The levels of specific inflammatory biomarkers, including interleukin-6 (IL-6), matrix metalloproteinases (MMPs), and tissue inhibitors of metalloproteinases (TIMPs), will be investigated using ELISA. The study aims to investigate the association between periodontal and ocular surface inflammation as well as investigate the common inflammatory pathways for both periodontitis and dry eye disease. These investigations might contribute to a better understanding of the systemic correlation that links both periodontal and ocular health.

Evaluation of Ophtholic Ultra for Ocular Surface Protection After Cataract Surgery

Study of the Effectiveness and Safety of Ophtholic Ultra in Preventing and Correcting Ocular Surface Disturbances After Uncomplicated Cataract Surgery This is a single-center, prospective, randomized, controlled, assessor-masked clinical study evaluating the effectiveness and safety of Ophtholic Ultra, a preservative-free moisturizing ophthalmic solution containing 0.2% tamarind seed polysaccharide and 0.4% sodium hyaluronate, in patients undergoing uncomplicated cataract surgery. Cataract surgery can temporarily affect the ocular surface and tear film, leading to dry eye symptoms, discomfort, epithelial changes, and reduced tear film stability. This study will evaluate whether adding Ophtholic Ultra to standard postoperative treatment can improve ocular surface condition after cataract surgery. Approximately 60 adults aged 50 to 70 years with age-related cataract will be randomized into three groups. One group will receive standard postoperative treatment plus Ophtholic Ultra for 3 months, the second group will receive standard postoperative treatment plus Ophtholic Ultra for 1 month, and the third group will receive standard postoperative treatment without moisturizing eye drops. The primary outcome will be the change in tear film break-up time (TBUT) from baseline to Day 90 after cataract surgery. Secondary outcomes will include Schirmer I test results, corneal epithelial staining and defects, visual acuity, patient-reported ocular symptoms and comfort, refractive outcomes, adherence, tolerability, and adverse events. Participants will be assessed before surgery and on Days 7, 30, and 90 after surgery.

Effect of a Dietary Supplement on Gut Microbiota and Ocular Surface Outcomes in Dry Eye Disease

This prospective clinical study investigates whether a dietary supplement product can modulate the gut microbiota and improve ocular surface outcomes in patients with dry eye disease. Participants will be recruited from Istanbul Medipol University Hospital (Department of Ophthalmology) and Liv Hospitals (Vadi Istanbul and Ulus). Each participant will receive the dietary supplement product for 8 weeks. Gut microbiota analyses will be conducted at baseline and week 8. Ocular surface assessments including Schirmer test and invasive tear breakup time (TBUT) will be performed at baseline and week 8.

Study of Eye Fatigue From Digital Screens and Its Impact on Visual Performance in People With Normal Vision and Myopia, With and Without Dry Eye Symptoms and Signs

The goal of this observational study is to investigate the effects of eye fatigue induced by screen task on dry eye disease (DED) signs and symptoms, visual performance, and visual behavior in young adults with and without DED and with normal vision and myopia. The main questions it aims to answer are: * Does a screen task that induces eye fatigue affect dry eye signs and symptoms, visual quality, and visual behavior? * Are the effects of this screen task different in individuals with and without DED, and are they associated with myopia? Researchers will compare participants with and without DED to determine whether they respond differently to a screen task designed to induce eye fatigue. They will also explore potential relationships between DED and myopia. Participants will: * Attend two study visits. * Complete eligibility screening and realize visual and eye assessments. * Be classified as having or not having DED based on a questionnaire and clinical eye examinations. * Perform a screen task designed to induce eye fatigue. * Perform measurements before and after a screen task, including assessments of DED signs and symptoms, blinking behavior, eye movements, visual performance, and physiological responses with a smartwatch.

Safety and Efficacy Study of RTP-008 (an Absorbable Tacrolimus Lacrimal Canalicular Plug) for Dry Eye

RTP-008, an absorbable tacrolimus lacrimal canalicular plug, targets two key pathophysiological mechanisms of dry eye: tear retention and local anti-inflammation. This clinical trial aims to evaluate the safety and efficacy of RTP-008 in adults with moderate to severe dry eye. The main questions it aims to answer are: * Is RTP-008 safe for the eyes? * How well does the plug work to improve dry eye? * Which size provides a better fit for the human lacrimal canaliculus after swelling? Participants will be divided into three groups: * Two groups will receive RTP-008 inserted into their lacrimal canaliculus (in two slightly different sizes). * One comparison group will receive an already approved dissolvable plug. All participants will use a standard lubricating eye drop four times a day in both eyes. All participants will attend follow-up visits for 24 weeks so doctors can check their eye health and any side effects.

Tolerability Comparison of Flarex to Lotemax SM

This study compared the ocular tolerability of fluorometholone acetate ophthalmic suspension 0.1% (FLAREX) to loteprednol etabonate ophthalmic gel 0.38% (Lotemax SM) in adult subjects. Each subject received one drop of each product, one in each eye, in a randomized, double-masked design. Comfort, impact on vision, and palpebral conjunctival injection were evaluated at 30 seconds, 5 minutes, and 10 minutes after instillation.

Proteomics Analysis of Human Tears in the Diagnosis and Management of Dry Eye Disease

In this study, the initial tear proteome profiles in Dry Eye Disease (DED) patients, the safety and effectiveness of using an EC certificate DED treatment device in DED management, together with the associated global tear proteome changes, will be investigated.

BriTer Eyez Moisture Vue™ On-Demand Disposable Moisture Chamber

The purpose of this study is to evaluate the short-term effects (impact on tear film and dry eye symptoms) of the BriTer Eyez Moisture Vue™ On-Demand Disposable Moisture Chamber (the device under investigation) in individuals with mild to moderate dry eye disease. Specifically, the study aims to determine whether wearing the device for two hours improves tear-film stability, tear volume, and tear osmolarity,

Effect of Oral Isotretinoin on Ocular Surface and Meibomian Glands

The aim of the study was to evaluate meibomian gland morphology using non-contact meibography and ocular surface changes in patients with acne vulgaris treated with isotretinoin as indicators of dry eye, which is known to be a side effect of isotretinoin.

Temporary Tear Duct Filling With Hyaluronic Acid Gel and Assessment of Dry Eye Disease (DED) After Bilateral Cataract Surgery

Dry eye disease can occur or worsen after cataract surgery and may cause ocular discomfort and reduced visual quality. Standard treatment commonly includes artificial tear eye drops, which provide temporary lubrication. Temporary occlusion of the tear drainage system may offer an alternative approach by increasing tear retention and improving tear film stability. This prospective, randomized, double-blind, inter-eye study will evaluate the use of LACRIFILL® Canalicular Gel, a crosslinked hyaluronic acid gel placed in the tear drainage system, in patients who have undergone bilateral cataract surgery. Treatment allocation will be randomized at the eye level within each participant. One eye will be assigned to treatment with LACRIFILL®, while the fellow eye will serve as the control and receive standard care with artificial tear eye drops. The study will compare the development and severity of dry eye disease between the randomized treatment and control eyes. The main outcome will be tear production measured by the Schirmer Test 1 one month after treatment. Additional assessments will include tear film stability, ocular surface findings, anterior segment imaging, visual quality, dry eye symptoms, use of artificial tears, and treatment-related safety outcomes during a three-month follow-up period.

Evaluation of Allogenic Mesenchymal Stem Cell (MSC) Injection Therapy for Refractory Graft-versus-Host Disease (GVHD) Unresponsive to Conventional Treatments

This Phase IIB, multicenter, double-blind, randomized, and uncontrolled clinical trial aims to assess the efficacy and safety of subconjunctival injection of Mesenchymal Stem Cells (MSCs) in patients with Graft-versus-Host Disease (GVHD) and severe ocular involvement (DYD-dry eye disease). The primary objective is to evaluate the clinically and statistically significant improvement in the signs and symptoms associated with the disease. Secondary objectives include: * Analyzing adverse events related to the subconjunctival injection of MSCs to confirm the safety of this treatment in patients with GVHD ocular involvement. * Identifying new biomarkers that can be used to objectively assess the progression of patients with GVHD and severe ocular involvement. * Studying the relationship between the expression of ocular surface-specific markers by MSCs and their clinical efficacy, as well as the variation in the expression of these markers in relation to cell preservation methods. Assessing the quality of life of patients treated with two doses of MSCs using the NEI VFQ-25 (National Eye Institute Visual Function Questionnaire). \- Evaluating whether the cell dose impacts clinical improvement. The trial includes 30 patients, divided into two groups of 15, and focuses on the assessment of dry eye disease, with the treatment based on MSC administration to improve clinical outcomes and quality of life for the patients.

A Clinical Study Evaluating Licaminlimab for Dry Eye Disease

The primary objective of this study is to evaluate the efficacy and safety of the topical ophthalmic administration of licaminlimab as compared to vehicle in participants with Dry Eye Disease and a specific genotype.

Evaluate the Efficacy and Safety of Amnion Membrane Disc Allograft vs Standard of Care in Participants With Dry Eye Disease

To evaluate the efficacy of Lyophilized Human Amnion Membrane Disc in reducing corneal epithelial damage as measured by the Lexitas Modified National Eye Institute (NEI) Grading Scale for Corneal Fluorescein Staining.

A Study to Assess Brillouin Hydration Mapping for the Evaluation of Ocular Tissues and Diseases

The overall goal of this study is to develop Brillouin microscope as a novel tool for measuring biomechanical and hydration properties of human tissues in vivo.

SYSTANE® PRO vs. MIEBO™ in Dry Eye Disease

This is a prospective, randomized, double-masked, multi-site clinical trial designed to compare the efficacy of SYSTANE® PRO (Alcon Laboratories, Inc.) to MIEBO™ (Bausch + Lomb) in treating symptoms of evaporative dry eye disease (DED). The primary goal is to determine whether SYSTANE® PRO is non-inferior to MIEBO™ after one month of treatment, based on change in Ocular Surface Disease Index (OSDI) scores.

New Preservative-free Combination of Trehalose, Sodium Hyaluronate and N-acetyl-aspartyl-glutamate (NAAGA) in Dry Eye

The goal of this prospective, non-randomized, non-comparative, monocentric PMCF study is to assess the performance of a new preservative-free combination of trehalose, sodium hyaluronate and NAAGA on DED at 6 months in 30 patients having dry eye disease. The main questions it aims to answer are: * To assess the performance and safety of T2769 at 3 months and 6 months. * To assess patient compliance to therapy. * To assess the occurrence of dry eye flares. Participants will be asked to use T2769 on a daily basis and complete a self-questionnaire throughout the study.

A Non-interventional Study to Evaluate the Anti-inflammatory Effects and the Clinical Efficacy of Topical Water Free Cyclosporin 0.1% Eye Drops in Patients With Dry Eye Disease and Associated Ocular Surface Inflammation Non-responding to Artificial Tears: the FOCUS Study

The FOCUS study aims to evaluate the clinical efficacy of 0.1% cyclosporine eye drops solution (Vevizye®, Laboratoires THEA) in patients with moderate to severe dry eye disease characterized by ocular surface inflammation.

POST CATARACT SURGERY DRY EYE DISEASE

Cataract surgery is one of the most frequent and successful interventions currently undertaken in medicine. However, a significant number of patients who underwent cataract surgery still complain about postoperative symptoms, such as irritation, pain, dryness, burning sensation, and foreign body sensation. Dry eye disease (DED) is a common postoperative symptom, with a prevalence fluctuating from 9.8% to 34% depending on the studies. The onset, or the worsening, of DED signs and symptoms usually occurs in the first postoperative week and may last for months affecting the satisfaction and quality of life of the patient. The reasons of dry eye development after cataract surgery include thermal and light toxicity from the microscope, corneal epithelial damage, repeated drying and irrigation of ocular surface during operation, sterilization of conjunctival sac and eyelid with chemicals, transection of the corneal nerves by corneal incision, use of topical anaesthetics, and preservatives in topical eye drops. The mainstay of post-cataract surgery DED prevention and management is the treatment with non-preserved artificial tears, which has shown good results in terms of the reduction in postoperative DED signs and symptoms in previous clinical studies. NOX-01 Ocular Drops is a medical device not already CE-marked. It is a preservative-free ophthalmic lubricant solution intended to be used in cases of moderate to severe dry eye in adults, regardless of gender. NOX-01 is a biomimetic emulsion which lubricates and protects the corneal surface, limiting the inflammation due to dry eye and stabilizing the tear film. The primary objective of this pilot and pre-market study is to assess the tolerance of NOX-01 on eye dryness syndrome before and after a cataract surgery, in patients with pre-existing mild to moderate DED, during 84 days of use (12 weeks). The performance of the product, used 4 times per day, in improving signs of symptoms of DED, will also be assessed before and after cataract surgery, as well as subject and investigator satisfaction.

The Effectiveness of Systane PRO Preservative Free Verses Blink Triple Care Preservative Free

The goal of this investigational study is to determine if Systane PRO Preservative Free is non-inferior to BLINK TRIPLE CARE in the clinically significant improvement of signs and symptoms of dry eye in patients over 4 weeks.

TRYPTYR as a Treatment for Patients With Dry Eye Disease (DED)

The purpose of this research study is to determine the effectiveness of TRYPTYR as a treatment for Dry Eye Disease. The primary efficacy variable is change from baseline in the Ocular Surface Disease Index (OSDI) at week 2. The co-primary efficacy variables are change from baseline in the National Eye Institute (NEI) scale of the cornea and NEI scale of the conjunctiva at 1 month (the third visit).

Dose-Finding Study of HUC1-394 in Participants With Dry Eye Disease

Clinical trial aims to determine the optimal dosing regimen by evaluating the efficacy and safety of HUC1-394 across different dosing frequencies in patients with moderate to severe dry eye disease.

Randomized Single Center Study to Evaluate Tolerability, Symptoms, and Visual Functional Outcomes With the Use of OTC Lubricating Eye Drops in Subjects With Dry Eye Disease

A study to evaluate the effect of over- the- counter (OTC) lubricating eye drops on tolerability, symptoms and visual outcomes in patients with dry eye disease (DED)

Safety and Efficacy of Topical Infliximab in Autoimmune Dry Eye Disease

Sjögren's syndrome is a condition in which the immune system attacks the body's moisture-producing glands. This often causes severe dry eye, leading to discomfort, irritation, blurred vision, and damage to the eye surface. Inflammation plays an important role in this process, and a protein called TNF-alpha is one of the key drivers. This study will test a new eye drop containing infliximab, a medication that blocks TNF-alpha. The goal is to see whether this treatment can safely improve symptoms and signs of severe dry eye in patients with Sjögren's syndrome.

An Exploratory Efficacy and Safety Study of DFL24498 Topical Ophthalmic Solution Compared With Vehicle in Participants With Dry Eye Disease

This is a Phase 2, randomized, multicenter, double masked, vehicle controlled, parallel group study to evaluate the efficacy and safety of DFL24498 topical ophthalmic solution versus vehicle in participants with dry eye disease. Approximately 417 participants aged 18 years or older who meet all eligibility criteria will be enrolled at study sites in the US. The study duration will be up to 16 weeks and will consist of three periods.