Conjunctivitis

Researchers are investigating the effects of an investigational cold treatment device called ETX-4143 on the eye's surface anatomy and inflammatory response in people with chronic ocular surface pain (COSP). This study aims to understand changes to corneal surface nerves and inflammatory mediators after treatment, while also evaluating the safety of this cooling device. The study involves detailed imaging and tear sample analysis to learn more about the condition and treatment impact. The ETX-4143 Device is a handheld cooling tool containing a frozen mixture that cools metallic probes touching the eye's conjunctival surface without direct contact with the frozen mixture. Before treatment, local anesthesia and a corneal shield are applied to protect the eye. Participants will receive a 4-minute cold treatment to the worse eye using this device. This single-center study will treat 5 adults with chronic ocular surface pain and follow them for 12 weeks. Participants will be screened for chronic ocular surface pain and will complete weekly eye pain questionnaires for 12 weeks. Clinic visits at 2, 6, and 12 weeks after treatment will include corneal surface imaging and tear sample collection. Both eyes will be assessed with confocal microscopy and tear osmolarity tests, using the untreated eye as a control. The main measurement is corneal nerve imaging analysis over the 12-week period, alongside safety monitoring by the medical team.

Researchers are evaluating the safety and effectiveness of DFL24498 eye drops compared with a placebo solution in adults with Atopic Keratoconjunctivitis (AKC), a condition involving inflammation and itching of the eyes. This phase 3, multicenter, randomized, double-masked study will include approximately 138 participants who meet specific criteria. The trial is sponsored by Dompé Farmaceutici S.p.A and aims to provide detailed information about this treatment for AKC. The study has three main periods: a screening period lasting up to one week before treatment, a 12-week treatment period where participants receive either DFL24498 or vehicle eye drops in both eyes, and a follow-up period lasting from week 13 to week 16. Rescue medication with dexamethasone sodium phosphate ophthalmic solution may be given if needed. The trial uses a randomized and triple-masked design to compare the study drug against a placebo. Participants will undergo various assessments including ocular itching scores, corneal staining, conjunctival redness, and other eye condition signs at multiple points during the study. Quality of life and patient-reported changes will also be measured. Safety will be monitored through adverse event reporting and visual acuity tests. The total participation duration spans from screening through the follow-up period, about 16 weeks in all.

Phacoemulsification is a common cataract surgery performed under topical anesthesia, which is generally safe but can cause pain, anxiety, and discomfort for some patients. This research evaluates the effect of oral anti-anxiety medication, specifically Alprazolam, on improving patient satisfaction during second eye cataract surgery. The study aims to clarify whether oral sedation can reduce pain, anxiety, and side effects like nausea and dizziness compared to no sedation during phacoemulsification. Patients will receive either a single oral dose of Alprazolam or a placebo tablet 30 minutes before surgery. The dose of Alprazolam is 0.5 mg for most patients, with a reduced 0.25 mg dose for those over 65 years or with liver disease. The study compares these groups to assess how oral sedation affects anxiety, pain, and surgical satisfaction. This is an extension study involving patients undergoing surgery on their second eye with topical anesthesia. During the trial, participants will complete questionnaires assessing pain, anxiety, and overall satisfaction before and after surgery. Researchers will monitor intraoperative discomfort and postoperative anxiety levels. Data from approximately 250 patients will be collected and analyzed for these outcomes. This study runs from March 2025 to December 2027, focusing on improving cataract surgery experiences safely and conveniently.

Researchers are developing and managing the AnovaOS Network Powered Patient Registry to collect real-world patient data across various diseases globally. This registry aims to capture meaningful clinical information on diagnosis, infection course, treatments, and outcomes to enhance understanding and support future clinical trials and observational studies. The registry serves as a resource to better understand, prevent, diagnose, and treat diverse health conditions. Participants' data will be gathered through this registry, which can also be used to recruit individuals for clinical trials and observational studies on promising therapies. The registry collects ongoing information on patients' health status and treatments, enabling long-term monitoring and analysis. This observational study does not involve administering treatments but focuses on data collection and management. Participants will provide information through questionnaires or instruments, either personally or via an informed proxy, with an expected follow-up once per year. The research team will assess natural history, clinical effectiveness, safety, and quality of care over a period of five years. The registry includes patients with a wide range of conditions, and participation requires informed consent and the ability to complete follow-up data collection.

Pterygium is a noncancerous growth of the conjunctival tissue over the cornea that can progress to cause vision problems, eye movement restrictions, chronic inflammation, and cosmetic issues. This clinical trial evaluates and compares two methods for securing conjunctival autografts during primary pterygium surgery: cauterization and fibrin glue. The study is randomized and controlled to assess which method may influence recurrence rates and other outcomes. The two interventions studied are cauterization, where a bipolar cutter is used to secure the graft with controlled cauterizing wraps, and fibrin glue, where a fiber adhesive is prepared and applied to fix the graft. The fibrin glue preparation takes about 10 to 15 minutes and is performed by a nurse. Both procedures aim to secure the conjunctival autograft during surgery to prevent recurrence. Participants will be followed for 180 days after surgery to monitor the recurrence of pterygium, surgical time, complication rates, astigmatism caused by pterygium, ocular surface condition, and postoperative symptoms such as discomfort, tearing, pain, and foreign body sensation. Pain and economic analyses will also be assessed at various time points including 7, 30, and 180 days after surgery. The study includes triple masking and random allocation to study groups.

Researchers are studying the relationship between clinical factors and the occurrence of adverse drug reactions in hospitalized patients who receive tropicamide/phenylephrine 8 mg/50 mg/mL. This study aims to identify which clinical determinants may increase the risk of these reactions and provide safety information for this commonly used ophthalmic drug combination. It also seeks to establish safety measures for patients undergoing eye examinations or surgery where these drugs are used. The study involves hospitalized patients scheduled for surgery who will receive two drops of tropicamide/phenylephrine 8 mg/50 mg/mL. Vital signs will be measured before administration and then at several time points afterward, including 5, 15, 30 minutes, and 1, 2, and 3 hours post-administration. Data will be collected using questionnaires and analyzed to find associations between clinical factors and adverse reactions. Participants will be monitored closely through vital sign checks and questionnaires during the study period. Researchers will evaluate adverse drug reactions and clinical determinants to understand their connection. The main outcome is to assess vital signs at set intervals following drug administration and identify any adverse reactions. The study is observational and aims to enhance the safety profile of this medication in hospitalized patients.

This research aims to develop and test a practical model for remote eye care consultation using vision self-testing. It focuses on overcoming barriers faced by patients, clinicians, and the healthcare system when adopting remote consultations, especially issues related to technology trust and visual acuity assessments. The study is observational and involves collaboration between patients, the public, and NHS staff to create a sustainable and inclusive solution. The study uses an innovative approach with the DigiVis app for vision self-testing during remote consultations. It takes place in three diverse NHS eye departments and involves co-designing the implementation model with stakeholders. Patients are assigned to the remote consultation pathway by their clinicians. The model will be evaluated before, during, and after 14 months of operation, including questionnaires completed online by both patients and staff to assess their experiences and attitudes. Participants will complete online questionnaires before and after their remote consultation to measure their views on the e-health technology, while staff will complete surveys to assess how well the technology is integrated into routine practice. The main outcomes include changes in patient perceptions and staff normalization of the technology over 30 months. The study will also collect qualitative data from interviews and focus groups to understand challenges and support model improvements. The overall participation duration can last up to 30 months including follow-up assessments.

Researchers are studying complex ocular infections, including endophthalmitis and corneal abscesses, to improve the methods used for microbiological diagnosis. These infections are challenging to diagnose because of small sample volumes and difficult access to the eye. New molecular tools like metagenomic sequencing and multiplex polymerase chain reaction (PCR) are being evaluated to optimize diagnosis accuracy and speed. The study involves patients with complex ocular infections. For endophthalmitis, next-generation sequencing (NGS) and culture methods will be used to analyze ocular samples. For corneal abscesses, multiplex PCR will be added to the diagnostic process to potentially shorten the time to diagnosis. These molecular techniques are being assessed alongside standard methods to understand their impact on diagnosis. Participants will provide ocular samples which will be tested with the new molecular techniques and traditional culture methods. Researchers will measure the positivity rates of samples within two weeks, and evaluate microbiological diagnosis accuracy, time to diagnosis, visual acuity, cure rates, and any changes in anti-infectious treatment during an 18-month follow-up. The study is observational and aims to improve diagnosis for better management of these infections.

Researchers are evaluating the effectiveness and safety of subcutaneous immunotherapy in patients aged 12 to 65 who have mild to moderate rhinitis or rhinoconjunctivitis, with or without mild to moderate asthma, caused by sensitivity to grass and olive pollen. This randomized, double-blind, placebo-controlled phase 3 trial aims to study allergy treatments to improve symptoms and reduce medication use over one year. Participants are randomly assigned to one of three groups: one receiving 10,000 TU/mL MG01 plus 10,000 TU/mL T517, another receiving 30,000 TU/mL MG01 plus 10,000 TU/mL T517, and a placebo group receiving the same solution without active ingredients. The allergen extracts come from a mixture of grasses and olive pollen, administered through subcutaneous injections. Treatment lasts for one year, evaluating different doses compared to placebo. During the study, participants will regularly record symptoms and medication use using a smartphone app. Researchers will monitor combined symptoms and medication scores as the primary outcome, along with medication-free days, symptom-free days, asthma exacerbations, quality of life tests for rhinitis and asthma, and immune response measures. Safety is closely followed through adverse reaction monitoring and immunological and security parameters over the 12-month treatment period.

Researchers are evaluating the effectiveness and safety of subcutaneous immunotherapy (SCIT) in people aged 12 to 65 who have allergic rhinitis or rhinoconjunctivitis, with or without mild to moderate asthma. The study focuses on patients sensitized to specific house dust mites, Dermatophagoides pteronyssinus and/or Dermatophagoides farinae. This is a phase 3, double-blind, placebo-controlled, randomized trial conducted at multiple centers. Participants will be randomly assigned to one of three groups: two receive different doses of SCIT (10,000 TU/mL or 30,000 TU/mL of allergenic extract), and one receives a placebo injection without active ingredients. Treatment lasts for one year, with doses administered subcutaneously. The study compares the two active treatment groups to the placebo group to determine which dose may be more effective and safe. During the trial, participants will be closely monitored for symptoms and medication use, assessed by the Combined Symptoms and Medication Score (CSMS) over 12 months. Researchers will also track medication-free days, symptom-free days, quality of life related to asthma and rhinitis, adverse events, and immunological responses. Participants will log symptoms and medication use via smartphone. Safety and treatment effects will be evaluated throughout the study period.