Soft Steroids and Dry Eye
I was amazed that a pharmaceutical company clearly implied in its recent advertising that using a soft steroid for long-term dry eye treatment is within the standard of care based on current medical guidelines. I was further astounded when some well-renowned optometric speakers recently made the same assertion at a major international optometric meeting!
These speakers supported the long-term use of soft steroids by citing a statement in the DEWS report (2007 Report of the International Dry Eye WorkShop, The Ocular Surface, April 2007). This statement was, Corticosteroids are an effective anti-inflammatory therapy in dry eye disease. Taking this one statement out of context to support this claim is insulting and disrespectful to the 70 international experts who spent more than three years generating this 130+ page report.
The DEWS report defined dry eye as a multifactorial disease of the tears and ocular surface that results in symptoms of discomfort, visual disturbance, and tear film instability with potential damage to the ocular surface. It is accompanied by increased osmolarity of the tear film and inflammation of the ocular surface. While inflammation is a part of the pathology of dry eye, this disease process requires much more than the temporary blockage of inflammation.
The DEWS report also noted, For patients with moderate-to-severe dry eye disease, the absence of preservatives is of more critical importance than the particular polymeric agent used in ocular lubricants. Preservatives that may not be toxic to the corneal epithelium of those with normal tear physiology can be devastating to dry eye patients, who have low tear volume. But, the preservative in the soft steroids is benzalkonium chloride (BAC), which is certainly not a preservative that should be used for long-term management of dry eye. The DEWS report says, Many components of eye drop formulations can induce a toxic response from the ocular surface. Of these, the most common offenders are preservatives such as benzalkonium chloride, which cause surface epithelial cell damage and punctate epithelial keratitis, which interferes with surface wettability.
Regardless of how soft these steroids may be, they are not totally safe or benign in their side effect profile, and this fact must be considered when making a decision on long-term treatment.
The side effects listed in the package inserts of these medications include subcapsular cataracts, glaucoma, secondary ocular infection from pathogens, and perforation of the globe where there is thinning of the cornea or sclera. One of the claims of the safer soft steroids, loteprednol, is that significant IOP rises (greater than 10mm) in patients treated for 28 days or more occur only 2% of the time. But, doesnt this imply that for every 50 dry eye patients treated with a soft steroid, at least one will be exposed to this IOP risk?
Promoting a BAC-preserved steroid for long-term use in treating dry eye is irresponsible, reckless and bad medicine. From a medico-legal perspective, a clinician experiencing an adverse event from the off-label use of such treatment would have a very difficult position to defend when better and safer alternative treatment is available.
Chuck Aldridge, O.D., M.B.A.
The use of an ester-based topical corticosteroid as adjunctive therapy in the control and management of dry eyes is indeed an enormous help to us in the care of our dry eye patients. This idea was well discussed by Stephen C. Pflugfelder, M.D., in the February 2004 American Journal of Ophthalmology (Anti-inflammatory therapy for dry eye), and we have found this experts perspective regarding topical steroid use most beneficial. We have found that a modified pulse-dosing schedule (such as q.i.d. for two weeks, then b.i.d. for a month or two) beautifully quiets the inflammatory component. Of course, such therapy is not done in a vacuum, but rather along with proper lubrication, such as TheraTears Liquid Gel or Soothe XP, depending upon the ocular surface status. Punctal plugs are employed as needed.
We have treated hundreds of patients in this manner, and we are very pleased with our clinical results. The limited, focused, short-term use of loteprednol has not resulted in epithelial toxicity in any of our patients, and we have seen none of the package insert potential side effects. We have prescribed steroids of all stripes for many thousands of patients, and have found this class of drug to be by far the most beneficial to our patients.
Finally, the use of Lotemax in this manner is not off-label.
Randall Thomas, O.D., M.P.H.
Ron Melton, O.D.
Time Well Spent
This is in regard to Dr. Monty Vickers Chairside column about the deluge of magazines and publications we receive every month (Information Overload, November 2006). I finally figured out how to catch up with all the journals and magazines: GO TO PRISON! I am currently incarcerated in
Name withheld
Occlusion Now in Obscurity
I enjoyed Remember When The Evolution of Diagnostic Technology, in the August 2007 issue. Irving Bennetts Remember Prolonged Occlusion? brought back memories of Dr. Raymond Roy at Pacific University School of Optometry in the late 1950s.
Dr. Roys techniques of occlusion to discover latent binocular dysfunction and the etiology of severe migraine headaches and photophobia served many of my patients with previous unresolved symptoms well. But, most of my colleagues in
Medicine is great, but its sad to see that some of the simplest techniques to discover and resolve patient complaints are sometimes ignored in favor of pharmaceuticals that may or may not be of value.
Howard Levenson, O.D. (ret.)
