View clinical trials related to Keratoconjunctivitis Sicca.
Filter by:Dry 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.
The purpose of this study is to compare the efficacy and safety of CKD-352 in patients with dry eye disease
The purpose of this study is to explore the efficacy and safety of CsA ophthalmic gel in the treatment of moderate to severe dry eye disease .
SDP-4-CS202 is a Phase 2, multicenter, double-masked, randomized, vehicle-controlled, parallel group study designed to evaluate the ocular efficacy of SDP-4 ophthalmic solution in subjects with moderate to severe dry eye disease over an 8-week treatment period. Once concentration (1%) of SDP-4 ophthalmic solution will be given in a parallel group to vehicle via topical ocular instillation BID.
This prospective study will use a self controlled design for 35 eyes. Patients scheduled to undergo routine cataract surgery in at least one of their eyes will have their pre-surgical measurements performed, IOL calculated and surgery planned. Then they will receive insertion of an intracanalicular dexamethasone insert into the inferior punctum. At 2 weeks (+/- 2 days) post-insertion, patients will return for an identical set of measurements. The IOL will be calculated and the surgery planned based on post-insert data. The insert will be removed if present (manually or via saline irrigation). This self controlled design allows for greater control of potential confounders tied to participants' systemic and ocular health.
This prospective, single-center, randomized, double-masked, parallel comparison, sponsored study seeks to investigate the efficacy of Intracanalicular dexamethasone Insert (IDI) on ameliorating the signs and symptoms of dry eye disease.
The objective of this trial is to evaluate safety and tolerability of CyclASol during long-term use in subjects with Dry Eye Disease.
The objective of this pivotal trial is to assess the efficacy, safety and tolerability of CyclASol in comparison to the vehicle for the treatment of signs and symptoms of Dry Eye Disease (DED).
This PMCF study is carried out following successful CE marking of NovaTears® + Omega-3 and is intended to generate systematic clinical data on the safety and performance of the device when used in accordance with the intended purpose.
Dry eye is the most common reason for visit to an ophthalmologist's office. The prevalence is on the rise and is mainly attributed to factors such as increased environmental pollution and contact lens use. The current management options are limited to over the counter artificial tear drops and three FDA-approved drugs. Of these, cyclosporine has been used worldwide for treating mild to moderate dry eyes. The earlier version consisted of 0.05% cyclosporine which worked well for a limited number of inflammatory dry eye conditions. Recently, 0.09% cyclosporine was approved by the FDA. The nearly double concentration is expected to be more beneficial for severe inflammation which is often seen in Sjögren syndrome and other Rheumatological conditions associated with dry eyes. In this pilot project, the investigator proposes to evaluate the change in expression of SLURP1 and other markers of ocular surface inflammation before and after treatment with 0.09% cyclosporine eye drops.