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Restasis (Cyclosporine Ophthalmic) - Summary

 
 



RESTASIS 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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NEWS HIGHLIGHTS

Published Studies Related to Restasis (Cyclosporine Ophthalmic)

Efficacy of cyclosporine for chronic, refractory stomatitis in cats: A randomized, placebo-controlled, double-blinded clinical study. [2013]
Sixteen cats with chronic stomatitis, that had previously undergone premolar-molar or full-mouth extractions, were randomly assigned a group to receive 2.5 mg/kg cyclosporine or placebo orally twice daily Neither the clinician nor the clients were aware of the group assignments... Whole-blood cyclosporine levels > 300 ng/ml were associated with significant improvement in oral inflammation in cats with chronic stomatitis that had previously undergone premolar-molar or fuill-mouth extraction.

The effect of prethrombolytic cyclosporine-A injection on clinical outcome of acute anterior ST-elevation myocardial infarction. [2013]
(TLT)... CONCLUSION: In this study, the prethrombolytic administration of CsA was not

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.

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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]

Dasatinib and Cyclosporine in Treating Patients With Chronic Myelogenous Leukemia Refractory or Intolerant to Imatinib Mesylate [Recruiting]
This phase I trial studies the side effects and the best way to give dasatinib and cyclosporine in treating patients with chronic myelogenous leukemia (CML) refractory or intolerant to imatinib mesylate. Dasatinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Cyclosporine may help dasatinib work better by making cancer cells more sensitive to the drug. Giving dasatinib together with cyclosporine may be an effective treatment for CML

Pilot Study of a Homeopathic Therapy in Combination With Cyclosporin (Restasis) in the Treatment of Dry Eye Disease [Recruiting]
The purpose of this study is to determine whether a homeopathic therapy in combination with cyclosporin (Restasis) is more effective than cyclosporin (Restasis) alone in the treatment of dry eye disease.

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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 >>


PATIENT REVIEWS / RATINGS / COMMENTS

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

  Rating
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

  Rating
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

  Rating
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: 2014-11-30

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