trial: treating ocular rosacea with Cyclosporin (Restasis)

Written by on July 25, 2006 in clinical trials, Ocular Rosacea with 4 Comments

A clinical trial to determine whether Restasis (topical cyclosporin) is effective in the treatment of ocular rosacea is currently recruiting patients. The study is designed to compare the `efficacy of topical cyclosporin (Restasis) with that of Refresh Endura for the treatment of the signs and symptoms of ocular rosacea in patients presently controlled on topical corticosteroids’.

The Inclusion criteria ;

Pt at least 18 yrs but younger than 65 Diagnosis of acne rosacea active ocular rosacea based on lid findings of meibomian gland dysfunction with lid telangectasia and hyperemia of at least 2+ Schirmers test of greater than 5mm in at least 1 eye If patient currently using lid hygiene must maintain regimen during study Stop oral antibiotics at least 4 weeks prio

Interestingly the exclusion criteria includes “Flax seed or Fish oil supplements within last 30 days”.

Clinical Trial NCT00348335: Efficacy of Topical Cyclosporin for Ocular Rosacea.

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About the Author:

David Pascoe started the Rosacea Support Group in October 1998.

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4 Reader Comments

  1. CDK says:

    I have a severe dry-eye condition and have been diagnosed with ocular rosacea. Currently, my opthamologist is treating me with punctal plugs in both lower puncta, a low dose of Minocycline, and Restasis twice a day. Since the Restasis literature makes it quite clear that Restasis shows no benefit in those with punctal plugs, WHY does my opthamologist continue to insist I continue the Restasis therapy? I have asked him, and he just shrugs off the disclaimer, saying it is not true. If it is not true, why would the drug company that produces Restasis make such a point of including the disclaimer on its own product? What is UP with that? Am I just subsidizing somebody’s big retirement, or what?

  2. peter beck says:

    My doctor has also prescribed restasis with punctum plugs. Does anybody know why restasis is not beneficial when you have the plugs?

  3. David Pascoe says:

    Hi Peter,

    Two entries from the Restasis FAQ are cryptic and don’t quite answer your question, but here they are;

    “How is RESTASIS Ophthalmic Emulsion different from artificial tears?

    Artificial tears temporarily lubricate the surface of the eye, but cannot increase tear production; RESTASIS® helps increase tear production in certain patients.

    How is RESTASIS Ophthalmic Emulsion different from punctal plugs?

    Punctal plugs can help keep tears on the surface of the eye longer, but cannot increase tear production; RESTASIS® increases tear production in Chronic Dry Eye patients whose tear production is presumed to be suppressed due to ocular inflammation associated with keratoconjunctivitis sicca.”

    and also;

    “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”.

    Here are some more comments that I think are also quite helpful Taking a Custom Approach to Dry Eye Treatment;.

    “Every patient is different, so every treatment plan needs to be different. When I have a patient who is moderately-to-severely dry, I recommend artificial tears and then add Restasis and plugs. I stagger the onset of each modality so that I can determine the efficacy of each. In cases where the dry eye symptoms are severe enough, I start the patient on Restasis and plugs simultaneously. In even more severe cases, I often add systemic flaxseed oil and then Similasan #1, which is a homeopathic eye drop.

    Here are more details about how I use the treatment options:

    Punctal plugs. Collagen is my first choice. I insert two plugs in each of the lower punctum, and have patients return in 2 weeks to gauge the effect. If they feel a benefit, I add silicone plugs or Medennium Smart Plugs. The Medennium Smart Plugs are long-acting and unlike some silicone plugs have the added advantage of not protruding though the punctum. In my experience, they last anywhere from 6 months to a year. (I also keep in mind that plugging can occasionally worsen symptoms in some patients because inflammatory cells stay in the eye longer.) Some patients also need occlusion of their upper puncta.

    Restasis. When I prescribe Restasis, I explain that the aim of the medication is to restore the ocular surface. I use uncomplicated language so patients can grasp the concept that Restasis gives the lacrimal gland a chance to produce more tears, and that the tears they’ll be making will be a better quality of tear and can “stick” to their eyes more effectively.”

    davidp.

  4. MARK says:

    I HAVE BEEN ON RETASIS FOR 6 MONTHS AND I HAVE LOWER PLUGS ALSO. I TAKE ARTIFICIAL TEARS TOO. MY DOCTOR THINKS ALL THESE THINGS COMBINED MAY HELP ME. I HAVE HAD EYE REDNESS AND BLOODSHOT EYES FOR 35 YEARS NOW AND THIS IS THE FIRST TIME I HAVE BEEN TREATED FOR OCULAR ROSACEA. THE OTHER DOCTORS TREATED ME FOR CONJUNCTIVITIS, BLEPHARITIS AND DRY EYE. THE DOCTOR I SEE NOW HAS FINALLY TOLD ME WHAT MY PROBLEMS ARE. FOR YEARS I DIDN’T KNOW WHAT WAS REALLY WRONG WITH ME.
    I AM HOPEFUL THAT THIS REGIMEN WILL HELP ME IN THE LONG RUN BUT AFTER ALL THE YEARS OF INSECURITY AND EMBARRASSMENT. IT REALLY DOESN’T MATTER ANYMORE.

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