Dry Eye Disease

Researchers are studying the immunologic changes on the surface of the eye in cancer patients, focusing especially on those with ocular graft-versus-host disease oGVHD. This observational, natural history study aims to understand risk factors, mechanisms of eye damage, drug targets, and effects of oGVHD on the eye over a period of up to four years. Two groups will participate cancer patients scheduled for bone marrow transplant, who will be evaluated every three months for two years, and healthy control patients without eye disease or cancer history, who will be evaluated every six months. During each visit, standard eye exams will be performed alongside collection of biological specimens such as ocular surface wash, mucocellular material, corneal filaments, impression cytology of conjunctiva, blood, or serum. Participants will attend periodic study visits for clinical exams and specimen collection while receiving their usual care. Researchers will assess various factors including eye disease risk, mechanisms of eye damage, and ocular effects of graft-versus-host disease. The study involves repeated evaluations and biological sampling to track changes over time, with a maximum follow-up of four years.

Researchers are evaluating the first use of a new imaging technology called 4D Microscope Integrated Optical Coherence Tomography 4D MIOCT combined with a Zeiss Artevo 800 surgical microscope during eye surgeries. This study focuses on adult patients undergoing clinically indicated surgery for various eye diseases, aiming to assess how easy the system is to use, its safety, and how well it visualizes the eyes structures during both front and back segment procedures. The study involves using the investigational 4D MIOCT device integrated into the Zeiss Artevo 800 microscope to capture detailed images of the eye during surgery. This imaging is performed in the operating room as part of the standard surgical care, with no additional treatment or interventions added. Up to eight patients may be enrolled, and images will be taken of one or both eyes during surgery to observe normal and abnormal microanatomy, as well as track any injections under the retina. Participants will have their eye imaged during surgery, and researchers will collect related clinical data and previous eye care records for comparison. The images and data will be analyzed after surgery to explore new details captured by the 4D MIOCT system. Researchers will measure ease of use, surgical workflow impact, and the presence of normal and abnormal microanatomy based on the images. There is no extra risk beyond the usual surgery, and no new medications or procedures will be performed solely for research purposes.

Researchers are evaluating the long-term safety and tolerability of dazodalibep in people with Sjgrens Syndrome. This phase 3 open-label study extends previous trials by continuing to monitor participants who completed 48 weeks of treatment with dazodalibep or placebo. The study is sponsored by Amgen and aims to better understand the safety profile of dazodalibep over an extended period. Participants who finished the initial 48-week trials HZNP-DAZ-301 or HZNP-DAZ-303 will receive an assigned dose of dazodalibep intravenously for an additional 132 weeks. This extension study involves a single treatment group receiving dazodalibep without placebo, focusing on ongoing treatment effects and participant safety. During the study, participants will be monitored for treatment-emergent adverse events for up to 152 weeks. Researchers will also measure the presence of anti-drug antibodies and plasma concentrations of dazodalibep for up to 132 weeks. Participants need to be available for all study visits and procedures, with safety assessments conducted regularly throughout the long-term extension period.

Researchers are evaluating the safety and effectiveness of Lacripep 4 M Ophthalmic Solution in people with Stage 1 neurotrophic keratitis NK, a condition affecting the cornea. This Phase 2 study compares Lacripep to a vehicle ophthalmic solution to see how each affects the eye surface, vision, corneal sensitivity, and quality of life. The trial involves about 54 participants and includes detailed eye image assessments by a central reading center to ensure objective results. Participants will first undergo a 2-week run-in period using the vehicle ophthalmic solution openly. Then, at the baseline visit, they are randomly assigned to receive either Lacripep 4 M or the vehicle solution. Both treatments are applied three times daily to both eyes for 8 weeks, with clinic visits at weeks 2, 4, and 8. After this, all participants enter a 4-week open-label phase where everyone receives Lacripep, allowing comparison of shorter and longer treatment durations. During the study, participants will have regular clinic visits for eye exams and assessments to monitor safety and effects on vision and corneal health. Researchers will measure the primary efficacy from baseline to week 8 and continue safety monitoring through week 12. The study includes checks on visual acuity, corneal sensitivity, and intraocular pressure, along with quality-of-life evaluations. Overall participation lasts about 12 weeks, including both masked and open-label treatment phases.

Researchers are studying XmAb657 to evaluate its safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity in healthy adults and adults with autoimmune diseases such as idiopathic inflammatory myopathies, systemic sclerosis, and Sjogrens disease. This Phase 1, first-in-human study aims to understand how the drug behaves in the body and its potential effects. Participants will receive XmAb657 by subcutaneous injection under the skin in a dose-escalation design. The study includes both healthy volunteers and individuals diagnosed with specific autoimmune diseases. The treatment phase involves administering XmAb657 and monitoring responses over time. During the study, participants will undergo various assessments including safety monitoring for treatment-emergent and serious adverse events, blood tests to measure drug concentration, and evaluations of pharmacodynamic effects. Researchers will track these outcomes through Week 52. Participants are expected to follow contraception requirements and attend scheduled visits for monitoring throughout the study duration.

Researchers are evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity, and early clinical effects of CND319 in healthy adults and patients with rheumatic diseases such as rheumatoid arthritis and Sjogrens syndrome. This Phase 1, first-in-human study consists of two parts a dose escalation phase and an open-label expansion, aiming to better understand how CND319 behaves in the body and its initial impact on these conditions. Participants will receive CND319 according to the dosing schedule assigned to their cohort. The study includes single ascending dose SAD and multiple ascending dose MAD parts, with the open-label expansion providing further evaluation. The dose escalation part assesses increasing doses to understand safety and drug behavior, while the expansion phase allows additional participants to receive the drug openly. During the study, participants will be closely monitored through various assessments including vital signs body temperature, heart rate, respiratory rate, blood pressure, pulse oximetry, ECG parameters, and laboratory safety tests from baseline through up to 12 weeks for SAD or 24 weeks for MAD and open-label parts. Researchers will also track the presence of anti-drug antibodies and pharmacokinetic measures such as drug concentration and clearance. Total participation duration depends on the study part but may last up to 24 weeks.

Researchers are evaluating the safety and effectiveness of a topical treatment called recombinant human proteoglycan 4 rhPRG4 for people with Sjgrens Syndrome who have dry eye disease. This Phase II, multi-center, randomized, double-masked controlled study is conducted in Australia to compare rhPRG4 to a placebo vehicle. The study aims to help improve symptoms and signs of dry eye related to Sjgrens Syndrome. Participants are randomly assigned to receive either rhPRG4 at a concentration of 450 gml or a PBS-based vehicle control. The treatment is applied topically to the eyes. The study lasts for 28 days, during which participants use the assigned treatment following the prescribed regimen. The trial includes regular assessments to monitor safety and efficacy throughout this period. During the study, participants attend scheduled visits where researchers evaluate eye health using corneal staining tests, symptom questionnaires including the SANDE score and visual analogue scales for dryness and discomfort, and eye examinations such as slit lamp evaluations and intraocular pressure measurements. Safety is monitored by observing any adverse events and changes in vision. The main outcome is the frequency of patients achieving complete resolution of corneal staining by day 28. Participants are asked to adhere to the treatment schedule and attend all visits during the trial duration.

Researchers are evaluating the safety and effectiveness of STSP-0902 ophthalmic solution in adults with neurotrophic keratitis NK, a condition affecting the cornea. This Phase II, double-blind, placebo-controlled study will enroll 48 patients diagnosed with Mackie Stage 2 or 3 NK in one or both eyes. The goal is to better understand how this eye drop treatment impacts corneal healing and eye health compared to placebo. Participants will be randomly assigned to one of three dosing groups low dose given three times daily, low dose given six times daily, or high dose given three times daily. Each group will include both patients receiving the active drug and those receiving a placebo. Treatments will be applied topically to the affected eyes for 8 weeks. If the eye is not healed after this period, patients may receive standard care during follow-up. During the study, participants will undergo various eye exams including slit-lamp exams, optical coherence tomography, and intraocular pressure measurements from screening through week 10. Researchers will monitor symptoms, vital signs, lab tests, and heart activity. Corneal healing, sensitivity, vision quality, tear secretion, and presence of antibodies against the drug will also be assessed. The total participation time includes the 8-week treatment and follow-up periods ending around week 10.

Researchers are evaluating KB801, a special virus-based treatment designed to deliver human nerve growth factor to the corneas of people with Stage 2 or 3 neurotrophic keratitis, a condition that affects corneal healing. This Phase 12 study is designed to assess the safety, tolerability, and early signs of effectiveness of KB801 compared to a placebo. The study is double-masked and placebo-controlled, involving participants with persistent corneal epithelial defects that have not improved. Participants will be randomly assigned to receive either KB801 or a placebo, applied topically to the affected eye once daily for 8 weeks. After completing treatment, they will return for a follow-up visit two weeks later to check on safety and the stability of corneal healing. Further safety monitoring will take place every three months for about one year while participants remain in the study. Throughout the trial, participants will undergo regular assessments to monitor safety, including tracking any adverse events. Researchers will evaluate healing of the corneal defects using specific measurements over 8 to 10 weeks. Safety follow-up visits extend through approximately one year to observe the durability of treatment effects and overall tolerability. Participants can expect regular visits for examinations and safety monitoring during this time.

Researchers are evaluating CLN-978, a CD19-directed T cell engager given by subcutaneous injection, in adults with active, moderate to severe Sjogrens Disease. This phase 1b, open-label study aims to assess the safety and tolerability of CLN-978 over 48 weeks in patients who meet specific disease criteria and laboratory parameters. Participants receive CLN-978 in two parts an initial dose escalation phase to find the appropriate dose, followed by further dose evaluation. The treatment is delivered subcutaneously at specified doses on specified days, monitored closely for safety and immune response. During the study, participants undergo regular assessments including blood tests to measure drug levels, immune cell changes, and anti-drug antibodies. Safety monitoring continues throughout the 48-week period, with researchers tracking disease activity and any adverse effects. The total study duration extends until March 2029, allowing long-term evaluation of treatment impact.