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)

Effect of loteprednol etabonate 0.5% on initiation of dry eye treatment with topical cyclosporine 0.05%. [2014]
randomized double-masked parallel group clinical study (NCT00407043)... CONCLUSIONS: Loteprednol etabonate induction therapy 2 weeks before the

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.

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Clinical Trials Related to Restasis (Cyclosporine Ophthalmic)

Study of Two Formulations of Cyclosporine Ophthalmic Emulsion in Healthy Volunteers and in Patients With Dry Eye [Completed]
This study will evaluate the safety, tolerability and pharmacokinetics of two formulations of cyclosporine ophthalmic emulsion in healthy adults (parallel-group phase). The parallel-group phase will be followed by a paired-eye phase which will evaluate the safety and tolerability of two formulations of cyclosporine ophthalmic emulsion compared with cyclosporine ophthalmic emulsion (RESTASIS®) in patients with dry eye.

Safety and Efficacy Study of Cyclosporine Ophthalmic Emulsion in Post-LASIK Patients [Completed]
This study will evaluate the safety and efficacy of cyclosporine ophthalmic emulsion administered twice daily following LASIK surgery

Efficacy of Cyclosporine Ophthalmic Emulsion in the Treatment of Dry Eye Syndrome in Contact Lens Wearers [Completed]
Cyclosporine Ophthalmic Emulsion is currently used in the treatment of dry eye syndrome. Contact lens wearers frequently suffer from dry eye syndrome. The purpose of this study is to evaluate cyclosporine ophthalmic emulsion verses re-wetting drops in the relief of dry eye symptoms in contact lens wearers

Safety and Efficacy of Cyclosporine Ophthalmic Emulsion in Patients With Primary Pterygium [Completed]
This study will evaluate the safety and efficacy of Cyclosporine Ophthalmic Emulsion 0. 05% (RESTASIS®) in patients with primary pterygium (abnormal growth on surface of eye).

Physician's Evaluation of Cyclosporine Ophthalmic Emulsion 0.05% [Completed]
The objective of this retrospective chart review is to evaluate the patient characteristics, treatment variations and efficacy of a second trial of Cyclosporine Ophthalmic Emulsion 0. 05% therapy in chronic dry eye patients who were initially treated with Cyclosporine Ophthalmic Emulsion 0. 05% but discontinued use after less than 12 weeks of treatment.

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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

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!