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Restasis Medical Research Studies

Up-to-date List of Restasis Medical Research Studies

What Research is Being Done?

A clinical study involves research using human volunteers (also called participants) that is intended to add to medical knowledge. There are two main types of clinical studies: clinical trials (also called interventional studies) and observational studies. Following list includes both interventional and observational studies.

Latest Restasis Medical Research Studies

Rank Status Study
1 Recruiting Study of Cyclosporine Ophthalmic Soution Group and Cyclosporine Ophthalmic Suspension Group
Condition: Dry Eye Syndromes
Intervention: Drug: Cyclosporine ophthalmic solution
Outcome Measures: Corneal staining test;   Ocular surface disease index (OSDI);   Tear break up time (TBUT);   Non-anesthetic Schirmer test;   Conjunctival staining
2 Not yet recruiting PK, Safety & Tolerability of CyCol® Versus Sandimmune® in Healthy Subjects
Condition: Healthy
Interventions: Drug: Sandimmun® IV;   Drug: CyCol® capsules
Outcome Measures: Pharmacokinetic variables for cyclosporine (in whole blood);   Concentrations (ng/g) of cyclosporine and its metabolites (AM1, AM9, AM4N) in colonic mucosa;   Safety and Tolerability of CyCol
3 Recruiting Double-Masked Trial of NOVA22007 (1mg/mL Ciclosporin/Cyclosporine) Versus Vehicle in Pediatric Patients With Active Severe Vernal Keratoconjunctivitis
Condition: Vernal Keratoconjunctivitis
Interventions: Drug: NOVA22007 ''Ciclosporin'';   Drug: Placebo
Outcome Measures: Compare the composite efficacy score over 4 months of treatment base on keratitis and need for rescue medication for two different dosing regimens of NOVA22007 versus placebo (vehicle of the formulation).;   Tolerability of will be assessed monthly through slit lamp examination, BCDVA, IOP and safety through vital signs, AE reporting, CsA blood levels and biological tests.;   The main secondary endpoints are the assessment of the corneal keratitis, the use of rescue therapy and the occurrence of ulcer which will be assessed monthly.
4 Unknown  Pilot Study of a Homeopathic Therapy in Combination With Cyclosporin (Restasis) in the Treatment of Dry Eye Disease
Condition: Dry Eye Syndromes
Interventions: Drug: euphrasia based homeopathic therapy and cyclosporin;   Drug: cyclosporin solution
Outcome Measures: Ocular Surface Disease Index OSDI;   Tear film breakup time;   Fluorescein staining;   Schirmer tear test with anesthesia
5 Recruiting Cyclosporine in Interstitial Cystitis: Efficacy, Safety and Mechanism of Action
Condition: Interstitial Cystitis
Intervention: Drug: Cyclosporine
Outcome Measure: To measure the effects of cyclosporine treatment on current perception and pain threshold using a Neurometer before, during and after treatment
6 Recruiting Prevention of Ocular Graft-Versus Host Disease With Topical Cyclosporine in Recipients of Allogeneic Hematopoietic Stem Cell Transplants Performed With a Reduced Intensity Conditioning Regimen
Condition: Ocular Graft Versus Host Disease
Intervention: Drug: Topical Ocular Cyclosporine
Outcome Measures: Ocular graft versus host disease is manifested by dry eye syndrome and disruptions in corneal integrity. The study will asses the efficacy of topical cyclosporine for preventing OGVHD manifestations;   Characteristics and clinical presentation of ocular graft versus host disease in patients receiving allogeneic bone marrow transplantation using a reduced intensity conditioning regimen
7 Not yet recruiting The Insulin Independence Trial (IIT) Evaluating the Safety and Efficacy of Oral Cyclosporine and Oral Lansoprazole for Insulin Independence Among Recent Onset Type 1 Diabetes Patients
Condition: Type 1 Diabetes
Interventions: Drug: Oral Cyclosporine A and Oral Lansoprazole;   Drug: Oral Placebos
Outcome Measures: Insulin Requirements among Recently Diagnosed Patients treated with Oral Cyclosporine and Oral Lansoprazole;   Glucagon stimulated C-peptide (area under the curve) and Hemoglobin A1C among Recent Onset Type 1 Diabetes Patients treated with Oral Cyclosporine and Lansoprazole
8 Recruiting Calcineurin Inhibitor (CNI) Versus Steroid Cessation in Renal Transplantation
Condition: Renal Transplantation
Interventions: Drug: cyclosporine;   Drug: Everolimus
Outcome Measures: To assess if superior graft function (GFR difference of 10 ml/min) will be achieved at 1 year after transplantation in cohorts of de novo kidney transplant patients treated with Myfortic-everolimus plus steroids compared to Myfortic-cyclosporine.;   To compare the evolution of graft function (estimated GFR by means of modified MDRD formula)during the first 5 years post transplantation.
9 Not yet recruiting The Insulin Independence Trial (IIT) Evaluating the Safety and Efficacy of Oral Cyclosporine and Oral Lansoprazole for Insulin Independence Among Patients With Existing Type 1 Diabetes
Condition: Type 1 Diabetes
Interventions: Drug: Oral Cyclosporine and Oral Lansoprazole;   Drug: Placebos
Outcome Measures: Insulin Requirements Among Patients Treated with Oral Cyclosporine and Oral Lansoprazole;   Glucagon C-peptide (under the curve) and Hemoglobin A1C levels among patients with existing type 1 diabetes treated with Cyclosporine and Lansoprazole
10 Recruiting Phase 2 Study of a New Ophthalmic Formulation of Cyclosporine (Restasis® X) in Patients With Dry Eye Disease
Condition: Dry Eye Syndromes
Interventions: Drug: Placebo;   Other: Sham;   Drug: Cyclosporine New Ophthalmic Formulation
Outcome Measure: Corneal Staining Score Using a 6-Point Scale
11 Recruiting Horse ATG in Patients With AA or Low/Int-1 Risk MDS
Condition: Leukemia
Interventions: Drug: hATG;   Drug: Cyclosporine;   Drug: Methylprednisone;   Drug: Pegfilgrastim;   Drug: Filgrastim
Outcome Measures: Achievement of Response;   Time to Response
12 Recruiting Copenhagen Head Injury Ciclosporin (CHIC) Study
Condition: Traumatic Brain Injury
Interventions: Drug: NeuroSTAT 5 mg/kg/day;   Drug: NeuroSTAT 10 mg/kg/day
Outcome Measures: Non-compartmental analysis of pharmacokinetics (PK) of Ciclosporin in whole blood;   Incidence of adverse events;   Ciclosporin levels in cerebrospinal fluid (CSF);   Safety biomarkers for nephrotoxicity;   Biomarkers of brain injury in brain tissue;   Brain tissue oxygen
13 Recruiting Comparison of Effect of Postoperative Cyclosporine A 2% Ophthalmic Emulsion and Betamethasone Eye Drop on Surgical Success of Trabeculectomy Procedure
Condition: Glaucoma, Open Angle
Interventions: Drug: Cyclosporine;   Drug: Betamethasone
Outcome Measures: Intraocular Pressure (IOP);   Bleb morphology;   Subjective dry eye symptoms;   Surgical success rate;   Complications;   Visual acuity
14 Unknown  Ciclosporin in the Management of New Erythema Nodosum Leprosum
Condition: Leprosy
Interventions: Drug: Ciclosporin;   Drug: prednisolone
Outcome Measures: time to relapse of ENL after initial control of symptoms;   time, in hours, to control initial episode of ENL relapse from time of starting anti-reactional medication;   time, in days, to ENL relapse from date of stopping anti-reactional medication
15 Unknown  Ciclosporin in the Management of New Type 1 Reactions in Leprosy
Condition: Leprosy
Interventions: Drug: Ciclosporin;   Drug: Prednisolone
Outcome Measures: improvement in nerve function;   incidence of adverse effects;   Skin lesion inflammation improvement;   rate of improvement of reaction;   Time to next reactional episode;   extra prednisolone needed to control reaction
16 Unknown  Ciclosporin in the Management of Chronic or Recurrent Erythema Nodosum Leprosum
Condition: Leprosy
Interventions: Drug: prednisolone;   Drug: ciclosporin
Outcome Measure:
17 Recruiting Investigation of Maintaining Visual Performance Achieved With Cyclosporine Therapy
Condition: Dry Eye Syndromes
Interventions: Drug: cyclosporine 0.05% ophthalmic emulsion;   Drug: carboxymethylcellulose-based lubricant eye drops
Outcome Measures: Visual Function Reading Speed;   Tear Film Break-up Time (TFBUT);   Ocular Protection Index;   Conjunctival Redness Score;   Ocular Surface Staining Score;   Blink Rate;   Ocular Symptoms Questionnaire Score
18 Recruiting Disposition Effects of Cyclosporin on Buprenorphine
Condition: Healthy
Interventions: Drug: buprenorphine;   Drug: Cyclosporine
Outcome Measures: Buprenorphine effects on Healthy volunteers;   Buprenorphine clearance from the body;   Buprenorphine metabolism;   Buprenorphine bio-availability;   Buprenorphine pupil diameter changes
19 Unknown  Ciclosporin in the Management of Steroid Resistant Type 1 Reactions in Leprosy
Condition: Leprosy
Intervention: Drug: ciclosporin
Outcome Measures: improvement in nerve function;   incidence of adverse effects;   Skin lesion inflammation improvement;   rate of improvement of reaction;   Time to next reactional episode;   extra prednisolone needed to control reaction
20 Recruiting CYCLosporinE A in Reperfused Acute Myocardial Infarction
Condition: Acute Myocardial Infarction
Intervention: Drug: Cyclosporine A
Outcome Measures: Improvement of myocardial reperfusion, measured with ST-segment resolution >=70%;   High sensitive cardiac troponin T (hs-cTnt).;   Clinical events: all-cause mortality, HF or shock; rehospitalization for CV reasons;   Infarct size: Troponin curve (T or I, assayed locally);   LV remodeling and function as assessed by echocardiography;;   No reflow, as assessed by myocardial blush

These studies may lead to new treatments and are adding insight into Restasis etiology and treatment.

A major focus of Restasis research is the development of new drugs and other treatment options. Studies seek to identify new drugs to treat various related disorders and to find safer, more effective doses for medications already being used. Other research is aimed at identifying receptors or drug targets.


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