Efficacy Study of FK-506 and Cyclosporine in Vernal Keratoconjunctivits (VKC)
KeratoconjunctivitisVernalThe study was a double-blind, parallel study to compare efficacy of 0.1% tacrolimus ophthalmic ointment vs 2% cyclosporine eye drops in children with vernal keratoconjunctivitis. The duration of the blinded period was 8 weeks followed with 4 weeks of open-period of tacrolimus ointment. The hypothesis was that tacrolimus was as effective as cyclosporine for the treatment of this condition.
Safety and Efficacy of Pimecrolimus Ophthalmic Suspension in Patients With Moderate to Severe Keratoconjunctivitis...
Keratoconjunctivitis SiccaThis 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.
Study of Rebamipide Eye Drops to Treat Dry Eye
Keratoconjunctivitis SiccaThe purpose of this study is to determine the potential safety and effectiveness of rebamipide eye drops, an investigational eye drop being developed for the treatment of keratoconjunctivitis sicca (dry eye).
PMCF Study to Evaluate Performance and Safety of "Distilled Waters-based Eyedrops" Used to Relieve...
Dry EyeDry Eye Disease1 moreDry eye disease (DED), also called keratoconjunctivitis sicca, is a common ocular condition characterized by a loss of homeostasis of the tear film and inflammation of the ocular surface. The typical symptoms of DED include irritation, discomfort, blurred or fluctuating vision. Over the counter (OTC) artificial tears are typically the first line of dry eye treatment; they are meant to supplement the tears that cover the eye's surface. OTC products mimic the different layers of the tear film in order to maintain ocular hydration. Distilled waters of natural herbs such as Green Tea, Calendula, Chamomile, Hamamelis and Euphrasia are known for their soothing and refreshing properties. Thanks to the combined action of these natural elements, distilled waters-based eyedrops are particularly indicated to relieve eye dryness, irritation and redness of the eyes' mucosa caused by atmospheric agents, environmental factors, and/or use of contact lenses. "Distilled waters-based eyedrops" medical devices are ophthalmic solutions containing distilled waters able to relieve eye discomfort thanks to their soothing and refreshing action. For these reasons, an interventional, non-comparative, single-center Post Marketing Clinical Follow-up (PMCF) study was planned to evaluate the performance and safety of "Distilled waters-based eyedrops" used as intended to relieve dry eye symptoms. The objectives of the PMCF study are confirmation of the performance, collection of additional safety data regarding expected adverse events and detection of potential unexpected adverse events associated with use of "Distilled waters-based eyedrops" according to the IFU. Each subject, after signing the Informed Consent Form, will enter the screening and baseline phase (the 2 visits will coincide) during which baseline procedures will be completed. At baseline visit (V0), one of the "Distilled waters-based eyedrops" products will be administered to the enrolled subject. The patient will perform 2 on site visits (V0 and V2/EOS). To monitor the safety, 1 phone contact is planned (V1) to check for potential adverse events and concomitant medications intake. The first administration and the intervals at which the treatment should be repeated, to be done as per Investigator judgment and according to the IFU, depend on various factors regarding the physiology of the patients (e.g. type of eye-tear film, anatomy, age), their lifestyle (e.g. use of computer, wearing of contact lenses).
A Safety and Efficacy Study of OPTIVE FUSION™ With VISMED® Multi for the Management of Dry Eye
Dry Eye SyndromesKeratoconjunctivitis SiccaThis study will evaluate the safety and efficacy of OPTIVE FUSION™ compared to VISMED® Multi for the management of dry eye.
A Phase 4 Study Investigating the Efficacy of Retaine™ in Managing Signs and Symptoms Associated...
Keratoconjunctivitis SiccaThis study will evaluate the efficacy of Retaine™ ophthalmic emulsion in treating the signs and symptoms of dry eye syndrome.
Double-Masked Trial of NOVA22007 (1mg/mL Ciclosporin/Cyclosporine) Versus Vehicle in Pediatric Patients...
Vernal KeratoconjunctivitisThe 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.
Intra-Nasal Mechanical Stimulation (INMEST) as a Treatment of Keratoconjunctivitis Sicca (Dry Eye...
Keratoconjunctivitis Sicca (KCS)The purpose of the study is to evaluate how treatment with Intra-Nasal Mechanical Stimulation (INMEST) in the nasal cavity in patients with Keratoconjunctivitis sicca can relieve these symtoms.
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)
Efficacy and Safety of GV 550 in Acute Adenovirus Keratoconjunctivitis
Acute Adenoviral KeratoconjunctivitisThe study objective is to evaluate the efficacy and the safety of GV 550 in comparison to placebo in patients with acute adenoviral keratoconjuncivitis.