NCT07191847 Assessment of CataClear, Tear Film Stability, Tear Volume, and Dry Eye Symptoms Using Stem Cells Fortified Eye Drops
| NCT ID | NCT07191847 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Ace Cells Lab Limited |
| Condition | Dry Eye |
| Study Type | INTERVENTIONAL |
| Enrollment | 300 participants |
| Start Date | 2025-04-22 |
| Primary Completion | 2025-12-01 |
Trial Parameters
Eligibility Fast-Check
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Brief Summary
Dry Eye Disease (DED) is a multifactorial condition that affects the ocular surface, leading to discomfort, tear film instability, and potential visual disturbances. Its global prevalence ranges between 5% and 50%, making it a significant cause of reduced quality of life and a growing burden on healthcare systems. Cataract, defined as a progressive opacification of the lens, remains the leading cause of preventable blindness worldwide, responsible for about 33% of all cases, affecting an estimated 94 million people. Its incidence increases with age and is influenced by factors such as ultraviolet exposure, diabetes, smoking, and genetic predisposition. Low- and middle-income countries (LMICs) face a disproportionately high burden due to limited access to surgical care. The economic impact of cataract is profound, including both direct costs (surgery, post-op care) and indirect costs (lost productivity, caregiver dependency), with global productivity losses estimated at $53 billion annually. Beyond economics, cataract significantly impairs quality of life, contributing to psychological distress, depression, loss of independence, and increased risk of cognitive decline. Addressing this burden requires integrated strategies that ensure equitable access to treatment, reduce financial barriers, and include psychosocial support. In parallel, emerging regenerative therapies such as stem cell-fortified eye drops offer new hope. These treatments, utilizing mesenchymal stem cells (MSCs), aim to restore ocular surface health in conditions like DED by reducing inflammation and enhancing tissue repair. The current study evaluates the efficacy of such drops in improving tear film stability, tear volume, and overall clinical symptoms using advanced diagnostic tools.
Eligibility Criteria
Inclusion Criteria: * Adults aged 18-80 years. * Diagnosed with dry eye disease (based on clinical criteria such as OSDI scores and Schirmer test results). Exclusion Criteria: * Exclusion Criteria: * History of ocular surgery or trauma. * Other ocular diseases (e.g., glaucoma, keratitis). * Systemic conditions that may interfere with study outcomes (e.g., autoimmune diseases).