The primary benefits of ophthalmic ointments include increased medication contact time and the potential to provide an added barrier to the ocular surface. More specifically, ointments may provide additional surface protection for patients with exposure keratopathy from Bell’s palsy, trauma, infection, eyelid tumors or incomplete blink.^1,2 Ophthalmic ointments have been particularly effective for patients who suffer from nocturnal lagophthalmos.³ Ointments are also routinely used after various surgical procedures and in neonatal applications.^4,5

Perhaps one of the most common uses for ophthalmic ointments is to treat lid diseases, such as blepharitis, contact dermatitis and atopic dermatitis.^6,7 Other areas of application may include allergic eye diseases—giant papillary conjunctivitis, vernal keratoconjunctivitis, atopic keratoconjunctivitis and even more severe forms of seasonal allergic conjunctivitis.^8-11

Several corneal conditions—including filamentary keratitis, keratoconjunctivitis sicca, corneal staining and corneal abrasions—often are effectively treated with ophthalmic ointments. In fact, one study indicated that ophthalmic ointments appear to be superior to pressure patching for traumatic corneal abrasions.¹⁴ So, in cases where a bandage lens may not be an option, an ophthalmic ointment likely is the next best alternative.

There are, however, a few disadvantages to the use of ophthalmic ointments. For example, many patients will experience temporarily blurred vision and tear film instability following application. Also, because of the extended contact time, the ocular surface could be exposed to preservative agents for a longer period. Lastly, the use of ophthalmic ointments will not work effectively with contact lens use or bandage lenses.¹⁵

Lotemax Ointment
In late 2011, Bausch + Lomb introduced preservative-free Lotemax ointment (loteprednol etabonate ophthalmic ointment 0.5%) for the treatment of inflammation and pain following ocular surgery. Safety and efficacy trials were conducted to compare Lotemax ointment to the delivery vehicle for the treatment of inflammation and pain following cataract surgery in 805 patients.¹⁶ Efficacy outcomes included the proportion of patients with complete resolution of anterior chamber inflammation, as well as the number of patients with no pain eight days after surgery.

Safety outcomes evaluated adverse events, ocular symptoms, intraocular pressure changes and visual acuity. Significantly more patients who received Lotemax ointment experienced complete resolution of anterior chamber inflammation and reported no pain eight days after surgery than those who received the vehicle.16

Additionally, fewer patients who used Lotemax ointment required rescue medications secondary to associated adverse events. The most common adverse events included anterior chamber inflammation, photophobia, corneal edema, conjunctival hyperemia, eye pain and iritis.¹⁶ Mean IOP decreased in both treatment groups; however, four of 805 patients exhibited a pressure increase of more than 10mm Hg—three of whom received Lotemax ointment.¹⁶

Truly Preservative Free?
It is essential to note that non-aqueous formulations do not support microbial growth. A certain level of water content must be present for microorganisms to grow. Lotemax ointment simply does not reach that level, and therefore does not require the addition of preservatives.

Researchers have categorized a host of microorganisms with respect to their capacity to grow and produce metabolites under various conditions.¹⁷ Bausch + Lomb conducted its own safety study that included several lots of Lotemax ointment. The ointment was inoculated with various microorganisms, including Staphylococcus aureus, Pseudomonas aeruginosa, E. coli, Fusarium solani, Serratia marcescens, Stenotrophomonas maltophilia and Bipolaris australiensis.¹⁸

The test units were stored at 20ºC to 25ºC, and the samples were tested at seven, 14 and 28 days post-inoculation by plating serial dilutions of sample aliquots on appropriate growth media and counting colony-forming units.¹⁸ Results showed that microorganism growth was not supported in any of the Lotemax ointment lots at all three time intervals.¹⁸

A Note on Preservatives
So, why is it so critical to mention that Lotemax ointment does not contain preservatives agents? Simply put, all non-dissolving preservatives in ocular preparations, such as benzalkonium chloride (BAK), show some toxicity. BAK is the most commonly used preservative in ophthalmic preparations.¹⁹ It is a quaternary ammonium compound, which is considered a detergent.

Studies have shown that BAK exhibits the ability to alter cell membrane permeability, causing the cell to rupture.^18,19 Other research on BAK has shown that the degree of epithelial damage—and the speed which it occurs—depends on its tissue concentration.^5,19

This phenomenon was less noticeable with lower percentages of BAK. It is interesting to note that other preservatives, including boric acid, chlorhexidine, chlorobutanol, ethylenediaminetetraacetic acid and paraben, do not affect cell viability.²⁰ 

We must evaluate all therapeutic options in practice, based on both clinical experience and current research. Being aware of new ophthalmic ointments, and understanding their advantages and disadvantages, can help you determine how to best utilize them in clinical practice.

Dr. Karpecki is a consultant to Bausch + Lomb. Neither he nor Dr. Shechtman have any direct financial interest in the products mentioned.

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