Tuesday, February 5, 2008

Study: Restasis vs. Refresh Plus

Well, DUH.

CONCLUSIONS:: Cyclosporine emulsion, but not artificial tears, increases goblet cell density and production of the immunoregulatory factor TGF-beta2 in the bulbar conjunctiva in patients with dry eye.


Translation, in the context of this specific study:

"Restasis might help clinical features of some kinds of dry eye but Refresh Plus doesn't."

Or maybe:

"The drug for which the co-pay alone could buy you six boxes of useless preservative free artificial tears does more than said tears."

No offense whatsoever to the illustrious editors of Cornea, for whom and for which I have unbounded respect, but show me a published peer-reviewed study suggesting a $10 product is as effective as, or more effective than, the blockbuster ophthalmic drug of the decade and I'll...

Hey, wait a minute! Why are they comparing Restasis to Refresh Plus? Are doctors out there complaining that Restasis doesn't work any better than artificial tears, so somebody had to go and prove them wrong? Hmph. Sacrilege!

Oh, you want the whole thing? Here:

Effects of Sequential Artificial Tear and Cyclosporine Emulsion Therapy on Conjunctival Goblet Cell Density and Transforming Growth Factor-beta2 Production.
Pflugfelder SC, De Paiva CS, Villarreal AL, Stern ME
Cornea. 2008 Jan;27(1):64-69.

PURPOSE:: To evaluate the effects of sequential treatment with artificial tears and cyclosporine emulsion on conjunctival goblet cell density and production of transforming growth factor (TGF)-beta2 in patients with dry eye disease. METHODS:: Patients with dry eye disease (N = 6) defined by an Ocular Surface Disease Index symptom score >/=25, Schirmer test 1 <10 mm, and corneal fluorescein and conjunctival lissamine green staining scores >/=3 were treated with artificial tears (Refresh Plus; Allergan, Irvine, CA) 4 times a day for 4 weeks, followed by 0.05% cyclosporine emulsion (Restasis; Allergan) twice a day for 12 weeks. Impression cytology was performed on the bulbar conjunctiva of both eyes at baseline, after artificial tear therapy, and after 6 and 12 weeks of cyclosporine therapy. Goblet cells were counted in 5 representative microscopic fields per membrane in those taken from the temporal and inferior bulbar conjunctiva of the worse eye, and membranes taken from the fellow eye were immunostained for TGF-beta2. RESULTS:: There were no differences in mean goblet cell density between baseline and 4 weeks of artificial tears in the temporal and inferior bulbar specimens. After 6 weeks of cyclosporine emulsion, goblet cell density was significantly greater than baseline and artificial tears in the inferior bulbar conjunctiva (P < 0.01). After 12 weeks of cyclosporine emulsion, goblet cell density was significantly greater than baseline and artificial tears in both temporal and inferior bulbar sites (P < 0.01). The number of TGF-beta2-positive goblet cells was also noted to increase after 6 and 12 weeks of cyclosporine therapy (P < 0.001). CONCLUSIONS:: Cyclosporine emulsion, but not artificial tears, increases goblet cell density and production of the immunoregulatory factor TGF-beta2 in the bulbar conjunctiva in patients with dry eye.

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