Explore the safety, usability of multidose preservative-free tears
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Ten years ago, we had one or two options for preservative-free artificial tears, and they were expensive and hard to find.
We gave preserved tears to patients with dry eye disease (DED) and recommended sparing use — twice a day — to limit the negative impacts of placing too much preservative on the ocular surface.
Today, we have many preservative-free options. With no more reason to compromise care, many of us who treat DED now recommend only preservative-free tears, and patients can use them as often as they like.
The slow entry into the market of preservative-free tears primarily resulted from the effort to engineer safe, large-quantity, multidose bottles that minimize contamination. Vials of preservative-free tears offered safety, but my patients with dexterity issues or arthritis found them nearly impossible to use. Patients often told me they had compromised sterility by using the same vial multiple times, and they hated the amount of plastic waste that vials create.
Instead, I look for a good, preservative-free artificial tear in a multiuse bottle that meets two basic criteria:
- To ensure the preservative-free artificial tears remain safe, the packaging design needs to prevent contamination.
- That design must also be easy for all patients to use.
Safety of multidose bottles
While major eye care companies have responsibly moved forward to safely manufacture preservative-free tears, recent headlines remind us again that not all manufacturers are the same. Unpreserved artificial tears were recalled for the presence of Pseudomonas aeruginosa, which caused 68 infections, including eight cases of vision loss and four enucleations and three deaths. Another eye drop was recalled because it was not manufactured under sterile conditions.
In both cases, FDA cited the manufacturers for violating Current Good Manufacturing Practices (CGMPs). All major companies that now offer multidose, preservative-free bottles stand by their adherence to CGMPs, which helps ensure the tears are not contaminated in facilities and bottles are manufactured according to strict guidelines.
Makers have designed multidose bottles to ensure preservative-free artificial tears remain uncontaminated during use. For example, Thea’s Abak bottle has a built-in filter cartridge and filter membrane that prevents microbes from entering the bottle, Alcon’s PureFlow design has a valve that prevents contaminants from entering and Aptar Pharma’s Ophthalmic Squeeze Dispenser, available on Allergan products, has a valve and air filter to keep out contaminants.
Since the recall news, I’ve had patients ask me about the safety of their eye drops. I tell them I feel comfortable with them because the manufacturer follows good practices. I’ve been recommending a lot of iVizia drops from Thea, which is the most popular brand in Europe and has used the third-generation Abak bottle since 2005, so there’s a long history of safety based on millions of bottles.
Ensuring bottles are easy to use
I mentioned the difficult times my patients have had using vials of tears. Multiuse bottles are a huge step up, but earlier iterations posed some challenges. Some made it hard to squeeze out drops, which is an issue for patients with dexterity problems, while others streamed out instead of coming out in individual drops.
The current range of bottles are much more user-friendly. I try all of the drops myself to evaluate whether my patients will easily be able to use them. In my experience, the iVizia bottle calibrates the drops, so they don’t stream out. This also is an affordable option, which checks another box for my patients.
Helping patients do their part
After we find safe, easy-to-use preservative-free tears for our patients, we need to make sure they purchase the right tears and minimize contamination at home. For me, the first is easy: I don’t list options. I tell them which tear I want them to use. This way, they don’t get confused or overwhelmed, and they get good results for their DED. I explain the reason for my choice and the benefits, emphasizing that all drops are different, and they need to stick with the one I recommend. Then I give them a sample, as well as a sheet where I’ve circled their drop and a QR code to buy more at my store.
As with any artificial tear, I tell patients to keep the bottle clean by not touching their eyes or eyelids, always put the lid back on all the way and replace their eye drops according to the guidelines for shelf life that are printed on the product’s box.
With good bottle design, safe manufacturing processes and smart habits at home, all my DED patients are safely and conveniently enjoying the benefits of preservative-free artificial tears.
References:
- Alcon readies multidose bottle for Systane Complete PF. https://www.reviewofoptometry.com/news/article/alcon-readies-multidose-bottle-for-systane-complete-pf. Published Jan. 13, 2022.
- Cases, deaths due to artificial tear-related infection continue to increase. https://www.healio.com/news/optometry/20230327/cases-deaths-due-to-artificial-tearrelated-infection-continue-to-increase. Published March 27, 2023.
- FDA warns Pharmedica over contamination controls for sterile eye drops. https://www.raps.org/News-and-Articles/News-Articles/2023/5/FDA-warns-Pharmedica-over-contamination-controls-f. Published May 16, 2023.
- The Abak system. https://www.laboratoires-thea.com/en/abakr-system.
For more information:
Cecelia Koetting, OD, FAAO, DipABO, is a clinical instructor in the department of ophthalmology at the University of Colorado School of Medicine.
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