72 Clinical Trials for Various Conditions
Atopic keratoconjunctivitis (AKC) is a rare type of ocular allergy that is often associated with eczema. Over time, the complications from this disease process lead to loss of vision due to continual scarring of the corneal surface. The pathophysiology of AKC has not been fully elucidated, and the triggers are still unknown. Corticosteroids are very effective in controlling the acute symptoms of AKC. However, two thirds of patients managed with a combination of oral antihistamine, topical mast cell stabilizer, and intermittent topical steroid regimen eventually developed significant keratopathy and vision loss. Additionally, there are many side effects of corticosteroids, including local immunosuppression, cataract formation, and increased risk of glaucoma. Cyclosporin A is an immunomodulator that specifically inhibits T lymphocytes by blocking the expression of the interleukin-2 receptor. It also blocks the release of inflammatory mediators from mast cells and eosinophils. Cyclosporin has no known side effects except for burning upon instillation, and safe to use over long-term . The investigators have demonstrated that a 0.05% ophthalmic emulsion of cyclosporine has been shown to be effective at improving the ocular signs and symptoms of AKC over short-term. However, the long-term efficacy of cyclosporine A in slowing the natural history of AKC and possible steroid sparing effects have not been assessed. The investigators hypothesize that cyclosporine A can be used as a mainstay treatment of AKC to control signs and symptoms over a long period of time and also prevent the progression of this disease.
Phase 2, randomized study to assess topically administered eyedrops of INV-102 compared to vehicle during 1-week dosing in participants with Acute Infectious Keratoconjunctivitis (AIK). Participants will return for a follow up visit 1 week after end of treatment.
This is a multi-center, double-masked, randomized, placebo-controlled, parallel-group, efficacy, safety, and tolerability study evaluating the efficacy of Dupilumab in the treatment of signs and symptoms of atopic keratoconjunctivitis (AKC).
The purpose of this pilot study is to assess repository corticotropin injection (RCI) in the form of H.P. Acthar Gel in patients with severe keratoconjunctivitis sicca (KCS, or dry eye disease). This pilot study is a non-randomized, open-label, interventional study to assess the efficacy and timeline of RCI for the treatment of severe KCS recalcitrant to conventional therapy. The purpose is to acquire preliminary data to support and guide the design of a future, double-masked, randomized, controlled clinical trial.
This is a Phase 1b, open-label, study to assess the effects of AK002, given as monthly intravenous infusion for 6 doses at up to 3 mg/kg.
This is a randomized, double-masked, vehicle-controlled study of the safety and efficacy of OTX-101 (0.09% cyclosporine nanomicellar solution) in the treatment of keratoconjunctivitis sicca to be conducted at approximately 50 sites.
This is a Phase 2/3 study to evaluate the safety and efficacy of 2 different dose concentrations of OTX-101 dosed twice a day in both eyes for 84 days compared to placebo (vehicle) in patients with keratoconjunctivitis sicca (dry eye disease).
The purpose of this study is to determine whether 0.2% and 0.5% R348 Ophthalmic Solutions are safe and effective in the treatment of Patients with Keratoconjunctivitis Sicca.
This study is being conducted to investigate the safety, comfort, and tolerability of 3 treatments: loteprednol etabonate ophthalmic (Lotemax®) gel 0.5 percent (%) administered twice daily (BID) with or without cyclosporine ophthalmic emulsion (Restasis) 0.05% administered BID, and Restasis 0.05% treatment alone for 12 weeks and at a follow-up safety visit 1 week post-treatment. This study will also investigate the relative efficacy of Lotemax gel 0.5% administered BID with or without Restasis 0.05% treatment administered BID and of Restasis 0.05% treatment alone for the reduction of clinical signs or symptoms of keratoconjunctivitis sicca (DED) over the first 4 weeks of a 12-week treatment period and at the end of a 12-week treatment period.
The objective of this study is to compare the efficacy of two different dosing regimen of NOVA22007 (1mg/ml ciclosporin/cyclosporine) eye drops, emulsion versus placebo (vehicle of the formulation) administered four times a day in patients with severe vernal keratoconjunctivitis after 4 months of treatment.
This study evaluates the efficacy and safety of Cyclosporine 0.010% eye drops in the treatment of Atopic Keratoconjunctivitis (chronic and severe inflammation of the eye). The study consists of a double-masked phase, and open-labeled phase, and an open-labeled maintenance phase. For the first 3 months of the study, patients will receive either masked Cyclosporine 0.010% eye drops or vehicle four times daily; for the next 6 months, patients may receive open-labeled Cyclosporine 0.010% eye drops four times daily. At month 9, patients who are in remission, will be re-randomized to receive either open-labeled Cyclosporine 0.010% eye drops four times daily or twice daily.
This is a first-in-man study for the purpose of determining the safety and tolerability of LX214 ophthalmic solution in healthy volunteers and in patients with dry eye syndrome.
This study evaluates the efficacy and safety of 2 doses of pimecrolimus (0.3% and 1%) ophthalmic suspension in a moderate to severe population of keratoconjunctivitis sicca (KCS, dry eye syndrome) patients.
The purpose of this study is to evaluate whether SkQ1 ophthalmic solutions are safe and effective compared to placebo for the treatment of the signs and symptoms of dry eye syndrome.
The investigators are conducting this study because the patient have an eye infection which is called adenoviral conjunctivitis, and is the most common cause of "pink eye". There is currently no treatment for this condition. However, the researchers associated with this study want to understand if using a product called Zirgan, which is a topical ointment that is already FDA-approved for other types of eye infections, will help with the type of infection that the patient currently have. Zirgan is not FDA-approved to treat your type of eye infection. Your participation in this study is expected to last 21 days but the patient will only apply the topical ointment for 14 of those days. During the study, the patient will be asked to come into this clinic 8 times. The purpose of this study is to determine whether topical Zirgan can reduce days that the patient suffers from the eye infection, and also to see if it can prevent the infection from spreading to your second eye and to also see if it can prevent the spreading of the infection to people that the patient come in close contact with. Zirgan will be compared to Genteal Gel in this trial. Genteal Gel is a non-prescription eye lubricant gel and is commonly used for treatment of dry eye. The patient will be asked to apply a topical ointment (either Zirgan or Genteal gel 5 times a day for the first 7 days and then 3 times a day for the following 7 days. The patient will be asked to return to the clinic 21 days after the patient starts the study for a final check-up. It is planned that about 80 people with Adenovirus Conjunctivitis will be enrolled in this study between 8-12 sites across the United States. The patient will be assigned to either Zirgan or Genteal gel by chance which is similar to flipping a coin. The study groups will be assigned in a 1:1 ratio. Neither the patient nor the study doctor or study staff will be able to pick which study group The patient is in. The patient will not know and the study doctor or study staff will not know which study group the patient is in. The study doctor or study staff can find out if it is necessary to know for your health. If this happens, the study doctor or study staff may not be able to tell the patient which study group the patient was in until everyone finishes the study.
To investigate and compare the burden of dry eye in Sjögren's syndrome dry eye vs non-Sjögren's syndrome dry eye, as well as investigate the diagnostic potential of tear film mucins and various inflammatory cytokines evaluated by tear fluid analysis and impression cytology.
The purpose of this study is to assess the safety and efficacy of 5% tavilermide and 1% tavilermide ophthalmic solutions compared with placebo ophthalmic solution in treating the signs and symptoms of dry eye.
The purpose of this study is to assess the safety and efficacy of Tavilermide Ophthalmic Solution compared with Placebo Ophthalmic Solution in treating the signs and symptoms of dry eye disease.
The purpose of this study is to assess the safety and efficacy of Tavilermide Ophthalmic Solution compared with Placebo Ophthalmic Solution in treating the signs and symptoms of dry eye.
This study will evaluate the efficacy of Retaine™ ophthalmic emulsion in treating the signs and symptoms of dry eye syndrome.
The purpose of this study is to evaluate whether, in people with dry eye syndrome, over the counter artificial tears and the prescription eye drop, dexamethasone, change or effect the eyes response to a low humidity environment. It is known that irritation from dry eye can be improved by over the counter artificial tears because they wet and lubricate the eyes. The prescription eye drop, dexamethasone, can also improve eye irritation by decreasing the inflammation that develops in dry eye. Thus, the investigators hypothesize that the use of these conventional dry eye treatments will improve the eyes' response to a low humidity environment.
The purpose of this study is to determine the safety, tolerability and pharmacokinetics of R348 eye drops in patients with dry eye disease.
The purpose of this study is to evaluate the effect of the controlled adverse environment (CAE) on Mean Break-Up Area in subjects diagnosed with Dry Eye Syndrome.
The purpose of the study is to evaluate the efficacy of SAR 1118 Ophthalmic Solution (5.0%) compared to placebo in the treatment of Dry Eye. The safety and tolerability of SAR 1118 Ophthalmic Solution (5.0%) compared to placebo in subjects with dry eye when administered BID for 12 weeks will also be evaluated.
Omega-3 fatty acids have been associated with a decline in inflammation. As dry eye disease is associated with inflammation of the ocular surface (DEWS report, Ocular Surface, 2007), the investigators hypothesize that the omega-3 fatty acid supplements used in this study will help to improve dry eye signs, such as eye surface irritation (staining) and tear film osmolarity, which is an overall measure of tear film stability and dry eye status. Further, the investigators hypothesize that dry eye symptoms, the end result of dry eye disease, such as discomfort and burning, will also improve with supplementation.
The purpose of this study is to evaluate the safety and efficacy of 2% rebamipide compared to placebo in clearing of fluorescein staining of the central cornea in subjects with dry eye disease.
The purpose of this study is to determine the effectiveness of a nutritional supplement in post-menopausal women age 40 or older with moderate to severe dry eyes. This study is being conducted to determine if signs and symptoms of dry eye will improve with the use of this nutritional supplement.
This is a prospective, observational case series to determine the clinical utility of tear osmolarity and other commonly used objective tests to diagnose dry eye disease, as well as to establish referent values for objective tests of the disease.
This study will evaluate the efficacy of cyclosporine ophthalmic solution vs. other non-prescription treatments in patients with dry eye disease. Patient and physician assessments completed at baseline, at each follow-up visit (follow-up visits are variable as per physician discretion) and at final follow-up visit.
This study is an exploratory trial evaluating the tear film break-up time after a single eye drop instillation of over-the-counter artificial tears. The primary hypothesis is that tear film break up time will be greater for test than control eye.