Assess the Safety and Efficacy of CsA Ophthalmic Gel in Subjects With Dry Eye
Dry EyeThe purpose of this study is to explore the efficacy and safety of CsA ophthalmic gel in the treatment of moderate to severe tear deficiency dry eye with different dosage, frequency and concentration, and to preliminarily determine the optimal dosage, frequency and concentration, so as to provide a theoretical basis for the design of follow-up clinical studies.
Dry Eye Syndrome, Healthy Control, Sjögren's Syndrome and Other Inflammation Disease in Taiwan Biobank...
Dry Eye SyndromeSjogren's Syndrome2 moreThe comprehensive analysis of health records, TCM constitution, biomarker, and whole-genome sequencing among dry eye syndrome, healthy control, Sjögren's syndrome and other inflammation disease in Taiwan: an integrated analysis between Taiwan Biobank and Sjögren's syndrome Database
An Open-Label Extension of a Phase 3 Study of OTX-101 in the Treatment of Keratoconjunctivitis Sicca...
Keratoconjunctivitis SiccaThis is a safety extension enrolling subjects participating in Study OTX-101-2016-001 (NCT02688556)
Dry Eye OmniLenz Application of Omnigen Research Study
Dry EyeDry eye disease (DED) is a disease of the ocular surface characterised by ocular surface inflammation and damage and neurosensory abnormalities. Tear film breakup leading to localised hyperosmolarity can result in ocular surface damage either directly or through the cascade of inflammation that it initiates. Transplantation of human amniotic membrane has been used for many ophthalmic indications including many related to inflammation of the ocular surface. A recent study published by McDonald and colleagues in 2018 conducted in 84 DED patients (97 eyes) receiving cryopreserved AM treatment (Prokera) in addition to prior maximal medical management demonstrated an improved ocular surface along with a notable reduction in disease severity scores. Omnigen is a dehydrated amniotic membrane derived from human sources and certified by the UK Human Tissue Authority. OmniLenz Bandage Contact Lens (BCL) is a bespoke bandage contact lens (BCL) designed to enable the application of Omnigen without the need for either sutures or glue. The application procedure takes approximately 15 minutes and the patients wear the lens continually. The McDonald study indicates that any improvement seen persists for at least three months. This study aims to expand on the work by McDonald et al. The study will be a randomised, parallel group study comparing Omnigen treatment applied with an OmniLenz BCL to OmniLenz BCL alone. The later treatment enables a degree of masking and for any difference to be attributable to the Omnigen rather than a contact lens. This is in line with the recommendations laid out be the DEWS group. Interim data and analysis will be conducted after enrolment of 20 patients. Following the first week application the eye will be assessed, and a further treatment applied for a further week. Therefore, the total treatment period will be two weeks with follow-up assessments at one and three months. At six months patients will complete an OSDI and EQ-5D assessment via email or post. The primary efficacy variability will be change in OSDI score, a patient reported scoring of dry eye symptoms. A number of clinical assessments of the ocular surface will also be performed as part of the secondary outcomes whilst the opportunity to measure a number of exploratory measures will enable further work following this study.
Study to Evaluate the Efficacy and Safety of CKD-352
Dry Eye DiseaseThe purpose of this study is to compare the efficacy and safety of CKD-352 in patients with dry eye disease
ACCURATE Study for Subjects With Dry Eyes
Dry Eye SyndromesTo determine treatment and imaging outcomes in bilateral ocular surface disease management with an intracanalicular dexamethasone (0.4 mg) insert compared to standard topical over-the-counter artificial tears lubrication management
Efficacy and Safety of PL9643 Ophthalmic Solution in Subjects With Dry Eye
Dry Eye DiseaseEvaluation of safety and efficacy of PL9643 Ophthalmic Solution compared to placebo for the treatment of the signs and symptoms of dry eye.
Safety and Efficacy of Two Different Concentrations (0.5% and 1%) of Progesterone Topical Gel Compared...
Dry Eye DiseaseMulticenter, Randomized, Double-Masked, Placebo-Controlled, Parallel-Group, Phase 2 clinical trial. The study objective is to evaluate the safety and efficacy of two different concentrations (0.5% and 1%) of progesterone topical gel compared to placebo, when administered twice a day for 3 months (12 weeks) in patients diagnosed with moderate to severe dry eye syndrome.
Dextenza With ILUX for Treatment of MGD
Meibomian Gland DysfunctionEvaporative Dry EyeTo evaluate the benefit of treatment with a physician administered intracanalicular dexamethasone insert in evaporative dry eye disease (DED) patients with meibomian gland disfunction (MGD) and underlying inflammation undergoing iLUX MGD Treatment System.
Comparison of Efficacy Between 100% Platelet-rich Plasma and 100% Serum Eye Drops in Dry Eye Disease...
Dry Eye DiseaseDry eye disease (DED) is a common eye problem, affecting 5% to 50% of the world population. Although the disease is not fatal, it substantially reduces quality of life and creates a high economic burden as high as over 50 billion from a societal perspective. Several biological tear substitutes (e.g., autologous serum (AS), autologous platelet rich plasma (APRP), and autologous platelet lysate (APL)) could effectively improve dry eyes, especially in patients with moderate to severe DED.. However, evidence on their comparative efficacy is controversial. The objective of the study is to compare the efficacy of 100% APRP with 100% AS eye drops in patients with moderate to severe DED.