The Dry Eye Zone

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Study: (yawn) Another Restasis cocktail

Evaluation of an isotonic tear in combination with topical cyclosporine for the treatment of ocular surface disease.

Hardten DR et al, Current medical research and opinion, 2007 Sep;23(9):2083-91

PURPOSE: To determine whether a new category of artificial tear product, carboxymethylcellulose 0.5% with compatible solutes (CMC-solutes) (Optive, Allergan, Inc., Irvine, California) improves clinical outcomes when used adjunctively with topical cyclosporine 0.05% (Restasis, Allergan, Inc., Irvine, California) for the treatment of ocular surface disease. METHODS: Nineteen patients with ocular surface disease treated with cyclosporine 0.05% for at least 3 months and who had previously used other artificial tears adjunctively were enrolled. Patients discontinued their previous artificial tear and used CMC-solutes, concomitant with topical cyclosporine 0.05%. Corneal evaluation and tear production parameters were evaluated before and during combined CMC-solutes/cyclosporine treatment. Patients also completed a questionnaire before and during treatment with combined CMC-solutes/cyclosporine. Follow-up was at 1 and 3 months. RESULTS: Most objective measures of ocular surface health were unchanged, but an improvement in conjunctival lissamine green staining and tear break-up time was found. Conjunctival lissamine green staining scores improved from 3.4 +/- 2.5 to 1.9 +/- 2.5 by Month 3 (p = 0.004). Tear break-up time improved from 4.6 +/- 3.9 s pre-treatment to 5.3 +/- 3.8 s post-treatment (p = 0.049). Ocular Surface Disease Index (OSDI) scores improved from 16.2 +/- 9.4 at baseline to 11.5 +/- 8.9 at month 3 (p = 0.007). Subjectively, patients graded their ocular discomfort as 2.7 at baseline and as 2.3 at Month 3 (p = 0.049). At Month 3, 89.5% of patients said they liked CMC-solutes as well or better than previous drops they had used. All patients said CMC-solutes provided similar or improved relief of symptoms of dry eye than previous eye drops. There were no tear-related adverse events reported. CONCLUSIONS: In this study, CMC-solutes, when used in conjunction with cyclosporine 0.05%, provided patients with an improvement in objective signs and subjective symptoms of ocular surface disease compared to their previous artificial tears. Further studies are warranted.

My translation: (Forgive me, or put it down to PMS...)

PURPOSE: To keep as many patients on Restasis as possible by finding yet another drop which if taken with Restasis might make them feel better. Oh, and to sell yet another Allergan product.

METHODS: Hand 19 random Restasis users (hm, wonder how long they had been on Restasis and whether they were at the magic 3 month point - or is the the magic 7 month point - or is it the magic 12 month point now?) yet another artificial tear (hm, wonder what they used to use and which ones the discontinuation of which is most likely to lead to improved comfort?) to try. Most of those tears have a honeymoon period before they join the drawerful of rejects in the bathroom, so there's always a chance they might like it better for long enough to capture some useful data.

RESULTS: No need to translate this part, I'll just quote: "Most objective measures of ocular surface health were unchanged". Ah, but OSDI improved. Go figger.

CONCLUSIONS: Start prescribing Optive with Restasis to patients who aren't yet showing any benefit from Restasis until somebody publishes a study with better results than this.

Like I said, I'm a cynical old thing, especially of a Wednesday morning without caffeine. Down in the depths of my heart...somewhere... I do sincerely appreciate all the efforts to make Restasis more tolerable.
Rebecca1 Comment