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Restasis (Cyclosporine Ophthalmic) - Summary



RESTASIS (cyclosporine ophthalmic emulsion) 0.05% contains a topical immunomodulator with anti-inflammatory effects.

RESTASIS ophthalmic emulsion is indicated to increase tear production in patients whose tear production is presumed to be suppressed due to ocular inflammation associated with keratoconjunctivitis sicca. Increased tear production was not seen in patients currently taking topical anti-inflammatory drugs or using punctal plugs.

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Published Studies Related to Restasis (Cyclosporine Ophthalmic)

Effect of cyclosporine-A on orthodontic tooth movement in rats. [2011.11]
CONCLUSIONS: We suggest that CsA enhanced the rate of orthodontic tooth movement. The osteopenia and the increased osteoclastic activity could be the underlying factors. (c) 2011 John Wiley & Sons A/S.

Safety and toxicology of cyclosporine in propylene glycol after 9-month aerosol exposure to beagle dogs. [2011.08]
BACKGROUND: Cyclosporine inhalation solution (CIS) delivered via nebulization is under evaluation for the prevention of chronic rejection post-lung transplant. A 300-patient randomized, controlled clinical trial (CYCLIST) is expected to be completed late in 2011. In support of this trial, a chronic inhalation toxicology study in dogs has been completed... CONCLUSION: The study supports the pulmonary and systemic safety of aerosolized CIS at expected lung dose levels/kg of up to 12 times greater than the average dose patients are receiving in the CYCLIST trial.

Prospective, randomized study of the efficacy of systemic cyclosporine in high-risk corneal transplantation. [2011.07]
PURPOSE: Immunologic rejection remains a major cause of graft failure in high-risk corneal transplantation. This study was conducted to elucidate the efficacy and safety of systemic cyclosporine (CsA) in high-risk corneal transplantation. DESIGN: Prospective, randomized, open-labeled clinical trial with a parallel-group study... CONCLUSIONS: No positive effect of systemic CsA administration for suppressing rejection in high-risk corneal transplantation was observed. With a relatively high incidence of systemic side effects, the results suggest that this protocol should not be recommended for corneal transplant recipients, especially those of advanced age. Copyright (c) 2011 Elsevier Inc. All rights reserved.

Belatacept-based regimens are associated with improved cardiovascular and metabolic risk factors compared with cyclosporine in kidney transplant recipients (BENEFIT and BENEFIT-EXT studies). [2011.05.15]
BACKGROUND: Cardiovascular disease, the most common cause of death with a functioning graft among kidney transplant recipients, can be exacerbated by immunosuppressive drugs, particularly the calcineurin inhibitors. Belatacept, a selective co-stimulation blocker, may provide a better cardiovascular/metabolic risk profile than current immunosuppressants... CONCLUSIONS: At month 12, belatacept regimens were associated with better cardiovascular and metabolic risk profiles, with lower blood pressure and serum lipids and less NODAT versus CsA. The overall profile of belatacept will continue to be assessed over the 3-year trials.

A randomized controlled study in patients with newly diagnosed severe aplastic anemia receiving antithymocyte globulin (ATG), cyclosporine, with or without G-CSF: a study of the SAA Working Party of the European Group for Blood and Marrow Transplantation. [2011.04.28]
We evaluated the role of granulocyte colony-stimulating factor (G-CSF) in patients with severe aplastic anemia (SAA) treated with antithymocyte globulin (ATG) and cyclosporine (CSA). Between January 2002 and July 2008, 192 patients with newly diagnosed SAA not eligible for transplantation were entered into this multicenter, randomized study to receive ATG/CSA with or without G-CSF...

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Clinical Trials Related to Restasis (Cyclosporine Ophthalmic)

Will Restasis Eye Drops Increase Your Chance of Having a Successful Surgery? [Completed]
The purpose of this study is to determine whether reducing inflammation of the surface of the eye with topical Restasis after glaucoma surgery will improve surgical outcomes and increase patient comfort.

Long-term Topical Cyclosporine for Atopic Keratoconjunctivitis [Recruiting]
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.

Low Dose Cyclosporin A in Primary Sj�gren Syndrome [Recruiting]

Double-Masked Trial of NOVA22007 (1mg/mL Ciclosporin/Cyclosporine) Versus Vehicle in Pediatric Patients With Active Severe Vernal Keratoconjunctivitis [Not yet recruiting]
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.

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 [Not yet recruiting]
The purpose of this study is to determine if oral cyclosporine and oral lansoprazole are effective in rendering recent onset type 1 diabetes patients, insulin independent. This four-arm study was designed to evaluate the safety and efficacy for insulin independence by utilizing the FDA-approved oral immune tolerance agent, cyclosporine, and the FDA-approved proton-pump inhibitor, lansoprazole. Lansoprazole and other proton-pump inhibitors increase gastrin levels. Gastrin was initially shown to have the potential to increase new beta cell formation in 1955 (Zollinger RM and Ellison EH. Ann Surg. 1955;142(4):709-23).

Studies with the immune tolerance agent, cyclosporine, previously demonstrated that among recently diagnosed type 1 diabetes patients, insulin independence was achieved in as many as 67. 5% of patients within 7 weeks of therapy (Bougneres PF et al. N Engl J Med. 1988: 17;318(11):663-70). Cyclosporine protected the remaining beta cells from further autoimmune attack, but over time, there was limited beta cell regeneration, and insulin was ultimately required by all patients. Therefore, this study proposes the usage of cyclosporine with a beta regeneration agent.

Follow-up studies for up to 13 years among 285 type 1 patients utilizing cyclosporine for 20 months, did not demonstrate renal or other side effects (Assan R. et al. Diabetes Metab Res Rev. 2002;18(6):464-72). Human clinical trials with gastrin and epidermal growth factor demonstrated reductions in daily insulin requirements by much as 75% within 3 months following four weeks of therapy among existing type 1 diabetes patients (Transition Therapeutics, March 5, 2007 http://www. transitiontherapeutics. com/media/archive. php Accessed January 1, 2013). Lack of the ability to sustain these results was likely due to the ongoing autoimmune attack on the new beta cells generated by therapy. Gastrin alone has been shown to induce beta cell neogenesis from human pancreatic ductal tissue without epidermal growth factor in in-vitro studies (Suarez-Pinzon WL et al. JCEM. 2005;90(6):3401-3409).

Type 1 diabetes is an autoimmune disease. Despite evidence that many different immune tolerance agents have successfully reversed diabetes in rodent type 1 models, none have been successful in sustaining insulin independence in man (Ablamunits V et al. Ann NY Acad Sci. 2007;1103: 19-32). The distinctions and complexities of islets in man are far different than that of rodents (Levetan CS and Pierce SM. Endocr Pract. 2012 Nov 27: 1-36 Epub ahead of print). We hypothesize that in man, both an immune tolerance agent and a beta regeneration agent are required to sustain insulin independence.

Based upon proton-pump inhibitors having been shown to increase plasma gastrin levels up to 10-fold, this clinical trial utilizes the oral proton-pump inhibitor, lansoprazole. This study will determine the safety and efficacy of cyclosporine used with and without lansoprazole to determine the impact on insulin independence among recently diagnosed patients with type 1 diabetes.

Cyclosporine is utilized to protect the new beta cells formed by lansoprazole. The combination of the two therapies may render reductions in insulin requirements and have a greater impact on sustained insulin independence than previously reported with cyclosporine or gastrin alone among type 1 patients.

This 12-week study consists of four treatment arms:

- Oral Cyclosporine/Placebo

- Oral Lansoprazole/Placebo

- Oral Lansoprazole/Oral Cyclosporine

- Oral Placebo/Oral Placebo

It is hypothesized that the combination of oral cyclosporine and oral lansoprazole will safely render significantly more patients with existing type 1 diabetes, insulin independent and may serve as a novel and innovative treatment approach for recently diagnosed patients with type 1 diabetes utilizing two FDA-approved therapies.

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Reports of Suspected Restasis (Cyclosporine Ophthalmic) Side Effects

Eye Irritation (258)Vision Blurred (105)Eye Pain (99)Ocular Hyperaemia (86)Foreign Body Sensation in Eyes (60)Lacrimation Increased (50)Drug Ineffective (48)Eye Pruritus (34)Eye Discharge (33)DRY Eye (24)more >>


Based on a total of 8 ratings/reviews, Restasis has an overall score of 7.38. The effectiveness score is 7.25 and the side effect score is 8.50. The scores are on ten point scale: 10 - best, 1 - worst. Below are selected reviews: the highest, the median and the lowest rated.

Restasis review by medical professional caring for 45 year old female patient

Overall rating:  
Effectiveness:   Highly Effective
Side effects:   Mild Side Effects
Treatment Info
Condition / reason:   dry eyes
Dosage & duration:   0.05 % twice a day (dosage frequency: 6 months) for the period of 6 months
Other conditions:   blepharitis
Other drugs taken:   none
Reported Results
Benefits:   Restasis helps with tear related problems: dryness, reflex overtearing, mucous discharge, irritated eyes, redness and lid swelling. It can irritate at the initial time of therapy but with extra artificial tears this effect is lessoned.
Side effects:   some people get prolonged stinging for 5 to 10 minutes and occasionally increased redness and lid swelling
Comments:   maintainence for chronic dry eye and sometimes helpful for blepharitis as well.


Restasis review by 58 year old female patient

Overall rating:  
Effectiveness:   Moderately Effective
Side effects:   No Side Effects
Treatment Info
Condition / reason:   Dry eye
Dosage & duration:   .05% (dosage frequency: 1 drop in each eye 2xday) for the period of 1 year
Other conditions:   none
Other drugs taken:   none
Reported Results
Benefits:   After several months using these drops I really could not tell much benefit. However, when I stopped using them for a month the dry eye problem was bad enough to make me realize they had been helping enough to make me realize I was better off with them than without. I continue to use them.
Side effects:   I had no side effects except some slight burning once in a while when I put them in my eye.
Comments:   I was to put one drop in each eye in the morning and again in the evening.


Restasis review by 48 year old female patient

Overall rating:  
Effectiveness:   Ineffective
Side effects:   Moderate Side Effects
Treatment Info
Condition / reason:   dry eye
Dosage & duration:   0.05% twice a day (dosage frequency: 0.05% twice a day) for the period of 3 months
Other conditions:   none
Other drugs taken:   none
Reported Results
Benefits:   This did nothing for my dry eyes, which cause me to have blurry vision at times.
Side effects:   Stinging when first applied, lasting approximately 15 minutes, and some redness.
Comments:   This medication is very expensive. Without insurance expect to pay between $270 - $300 for a month supply, depending on which pharmacy you use. Even with insurance it costs me $68 a month. If you read the insert that comes with the drops it states that clinical trials show only 15% of patients show improvement. Had I read that BEFORE I wasted the money on 3 montjs worth of this stuff I wouldn't have even bothered. Waste of money!

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Page last updated: 2011-12-09

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