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Benzalkonium Chloride-Free Travoprost Significantly Better on Ocular Surface Disease Index Compared With Other Ocular Hypotensive Drugs: Presented at ARVO

By Cameron Johnston

FORT LAUDERDALE, Fla -- April 30, 2008 -- Removing the preservative benzalkonium chloride (BAK) from travoprost, an ocular hypotensive drug, significantly reduces the incidence of troubling side effects such as ocular surface disease and hyperaemia.

The drug has had the preservative BAK removed and replaced with a proprietary product known as SofZia.

This finding was presented here on April 29 at the Association for Research in Vision and Ophthalmology (ARVO) 2008 Annual Meeting.

Ocular surface disease and ocular hyperaemia are common side effects of ocular hypotensive drugs, causing many glaucoma patients to become noncompliant with their prescription medications. A significant cause of these side effects is BAK.

In a 3-month study, 691 patients who had been using either latanoprost or bimatoprost were switched to a BAK-free formulation of travoprost. Prior to switching drugs, the patients were evaluated for ocular surface disease, dry eye, baseline intraocular pressure (IOP), and baseline hyperaemia. After using BAK-free travoprost daily in the evenings for 3 months, patients were re-evaluated for the same parameters.

The mean score on the Ocular Surface Disease Index (OSDI) of 12.0 for patients using latanoprost was reduced to a mean score of 8.7 when patients were switched to BAK-free travoprost. Similarly, the mean OSDI of 13.2 for patients using bimatoprost was reduced to 8.7 when the subjects were switched to BAK-free travoprost.

The OSDI regards any score of greater than 32 as being severe, while moderate disease is 23 to 32 and mild is 13 to 22.

The change in OSDI was greatest among patients whose index score was severe at baseline (45.8 points) compared with poststudy results (mean score = 24.6). In fact, 23.4% of patients whose disease was severe at baseline improved to moderate, and one third improved to mild disease over the course of the study.

Moreover, 78% of those who were considered severe at baseline had clinically significant improvements in their OSDI -- meaning that their score improved by at least 9 points. The differences from baseline were statistically significant for mild and moderate cases as well.

There was also a measurable change in IOP when the patients switched from either latanoprost or bimatoprost to BAK-free travoprost, and although these changes were considered statistically significant, they were not clinically relevant, and never amounted to more than 0.6 mmHg.

According to James H. Peace, MD, Ophthalmologist, Diabetic Eye Medical Clinic, Inglewood, California, these findings may have clinical importance for glaucoma patients beyond the lessening of ocular surface disease symptoms, because patients may become more compliant and start to use their drugs as prescribed. This, in turn, could lead to improved IOP control, he noted.

Funding for this study was provided in part by Alcon Laboratories, Inc.

[Presentation title: Ocular Surface Benefits of Using Travoprost BAK Free Compared to Prior Prostaglandin Therapy. Abstract A269]

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