Combination Therapy Bests Traditional Cyclosporine for Dry Eye

Treatment with combined cyclosporine 0.1% and loteprednol 0.2% led to significant improvements in corneal higher-order aberrations compared with cyclosporine 0.05%, according to a study presented at the American Academy of Ophthalmology annual meeting.

In this exclusive MedPage Today video, John Hovanesian, MD, of Harvard Eye Associates in Laguna Hills, California, outlines the findings from the CLEAN study.

Following is a transcript of his remarks:

Hi, I am John Hovanesian. At the American Academy of Ophthalmology meeting in San Francisco, I presented a study that we did over the past year or so with my colleagues, Tom Chester [MD, of the Cleveland Clinic] in Cleveland and Rob Sorenson [MD, of Inland Eye Specialists] in Hemet, California. And it was a study to look at the question of how do we best optimize the ocular surface, particularly if you’re thinking about patients who have cataract surgery.

Higher-order aberrations are the most important thing that we need to smooth out if we want to have accurate biometry and if we want to have a satisfied patient after cataract surgery.

So, cyclosporine is a well-established drug that helps normalize dry eye, but it really, for most people, doesn’t work quickly enough to achieve a good result. So in this study, we compared in a randomized prospective multicenter trial, two different formulations of cyclosporine. One is the familiar Restasis, and the second is a formulation from Harrow called Klarity CL, which contains cyclosporine 0.1%, not identical, but very similar to Restasis, with loteprednol 0.2%.

So having the steroids should improve things significantly. The study involved a total of 36 patients who were randomized between both groups, and what we saw in the study was a significant improvement in patients who had both drugs across most measures. But higher-order aberrations were different. With higher-order aberrations, we had significant improvement in those patients who received the combination drug of cyclosporine and loteprednol, but not in those who received cyclosporine or Restasis alone, so Klarity CL quickly, and this is within 2 weeks of initiation of therapy, and the effect persisted out to 4 weeks.

Now, we did a number of other measures of success with treatment with dry eye products, including speed scores, which significantly improved in both groups. Not surprising, both products have a nice soothing vehicle. Corneal staining actually improved in both groups significantly better than baseline with both the combination cyclosporine/loteprednol and with cyclosporine alone. Tear breakup time also improved as you’d expect it to, as we start to normalize the tear film. And finally, conjunctival redness.

Both drugs in the study were well tolerated. Patients had no trouble continuing to take them through the, in this case, 1 month of therapy. And I think that if you’re trying to rapidly clean up the ocular surface, particularly for surgery, 1 month is an appropriate time frame, 1 month or less really; here we saw results at 2 weeks.

So, the take-home messages of this study would be that with the combination drug of cyclosporine/loteprednol, we saw significant improvements as early as 2 weeks with the combination drug with cyclosporine/loteprednol, and we saw significant improvements with both drugs at 4 weeks in corneal staining, tear breakup time, ocular redness, and symptoms. I’m John Hovanesian, thanks for watching.