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 eye's 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.

Dry Eye Disease (DED) is a long-term condition caused by insufficient lubrication in the eyes due to low tear production or poor tear quality. This study aims to compare the safety and effectiveness of a new artificial tear formulation called ABBV-444 with Refresh Optive UD over a 90-day period in adults diagnosed with DED. The research involves around 250 participants across approximately 20 sites in the US to evaluate these treatments for managing dry eye symptoms. Participants first undergo a 7-day run-in period using REFRESH PLUS® eye drops. Those who qualify are then randomly assigned to receive either ABBV-444 or REFRESH OPTIVE® Unit Dose eye drops, both given as needed but at least twice daily for 90 days. This double-masked, randomized trial compares these two treatments during the study period to assess their impact on dry eye disease. Throughout the study, participants will attend multiple visits at the study sites for medical assessments and complete questionnaires to monitor treatment effects and side effects. Researchers will measure changes in the Ocular Surface Disease Index (OSDI) score and track any adverse events from baseline to day 90. Additional evaluations include tear breakup time and ocular surface staining to assess changes in eye surface health during the treatment period.

Researchers are evaluating the long-term safety and tolerability of dazodalibep in people with Sjögren's 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 the safety, tolerability, how the body processes, and immune response to XmAb657 in healthy adults and adults with autoimmune diseases such as Idiopathic Inflammatory Myopathies, Systemic Sclerosis, and Sjogren's Disease. This is a Phase 1, first-in-human, open-label clinical trial evaluating the effects of XmAb657 given by injection under the skin. The study aims to better understand the potential effects of XmAb657 in these populations. Participants will receive XmAb657 as a subcutaneous injection in a dose-escalation format. The study includes healthy adults and adults diagnosed with specific autoimmune diseases based on established classification criteria. The treatment is administered under medical supervision, and dosing levels may increase over time to monitor safety and immune responses. During the study, participants will be monitored for any side effects or adverse reactions, including serious or treatment-emergent events, through week 52. Blood samples will be collected to measure the levels of XmAb657 and assess its effects on the immune system. The study involves regular visits for safety assessments and pharmacokinetic and pharmacodynamic evaluations. Participants may be involved for up to a year to ensure thorough monitoring.

This research aims to evaluate the safety and effectiveness of a topical treatment called recombinant human proteoglycan 4 (rhPRG4) in people with Sjögren's related Dry Eye Disease. The study is a phase II, prospective, randomized, and double-masked trial conducted across multiple centers in Australia. It focuses on improving symptoms and healing the eye surface in adults diagnosed with Sjögren's Syndrome who experience dry eye symptoms. Participants will be randomly assigned to receive either rhPRG4 at a concentration of 450 micrograms per milliliter or a placebo vehicle control. The treatment is applied topically to the eyes, and the study lasts 28 days. The trial compares the effects of rhPRG4 with the placebo to assess its impact on corneal damage and dry eye symptoms. During the study, participants will attend scheduled clinic visits where researchers will examine their eyes using fluorescein staining to measure corneal healing and perform other eye assessments such as slit lamp examination and intraocular pressure checks. Symptoms like dryness, burning, itching, and blurred vision will be recorded using questionnaires and visual scales. Safety will be closely monitored by observing any adverse events and changes in vision. The total study duration for each participant is 28 days from baseline to end of treatment.

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 eye(s) 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 1/2 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 a fixed-dose combination of lifitegrast and perfluorohexyloctane eye drops to study their effects on signs and symptoms of dry eye disease. This Phase 2, randomized, double-masked, parallel-group, active-controlled, multicenter study aims to assess the safety and efficacy of treatments administered twice daily over four weeks. The study includes adults aged 18 and older who have experienced dry eye disease symptoms for at least six months. Participants will be assigned randomly to one of six groups receiving either the lifitegrast/perfluorohexyloctane combination, lifitegrast alone, perfluorohexyloctane alone, or a placebo vehicle. All treatments consist of topical ocular drops administered twice daily for four weeks. The study compares the combination therapy with individual drugs and placebo to evaluate their effects on dry eye disease. During the study, participants will undergo assessments including corneal fluorescein staining to measure changes from baseline over 29 days. Researchers will monitor signs and symptoms of dry eye disease at screening, baseline, and throughout the treatment period. Participants are expected to follow all trial instructions and attend visits for evaluations to track treatment impact and safety.