How to Educate DED Patients About Safe Eye Drops and Recent Headlines—and Handle Cases Exacerbated by Generics

By Lisa K. Feulner, MD, PhD

I recommend preservative-free artificial tears for my patients with dry eye disease (DED) every day, and I’m confident that the drops I recommend are safe and approved by the FDA. However, I’m also mindful that my patients have access to generic eye drops with unknown inactive ingredients and preservatives that can undermine the management of DED. And with recent headlines serving as a harsh reminder, I’m also aware that patients can purchase drops that are manufactured under potentially dangerous conditions—something my patients have also seen in the news.

Here’s how I make sure my patients are using safe eye drops, answer their questions about eye drop safety, and handle cases where generic drops affect ocular health.

Ensuring Patients Use Safe Eye Drops
In my experience, the best way to ensure that patients choose safe, brand-name artificial tears from the long shelves of similar-looking drops is to tell them which drops I want them to buy in writing. I give all my patients a form that lists the drops they can use, so they can take it with them and avoid any confusion in the store. I know the temptation to buy generic eye drops still exists, so I also explain the potential safety and efficacy problems with generics. Put simply for patients, although the active ingredients are the same, the other ingredients may be different, which can impact comfort, safety, and efficacy.

Some patients have expressed concern about eye drop-related deaths and vision loss in the news. I explain to them that while specific causes are not yet known, the problems resulted from some manner of manufacturing problems—another reason it’s important for them to stick to my brand-name recommendations. Brand-name manufacturers go through a research and development process that ensures the highest quality of manufacturing and dispensing, and they follow the FDA’s Current Good Manufacturing Practice (CGMP) regulations and oversight, which ensure that their eye drops are sterile, safe, and stable from the first use to the last. With preservative-free eye drops, which are essential for my DED patients, it’s even more important to know that tight manufacturing controls and good multi-use bottle design are preventing contamination, but we can’t be certain that’s true for all generic drops.

Complex Case: DED, Demodex, and High-Dose Generic Eye Drops
When patients are referred to me for DED treatment, it’s common to find that they’ve exacerbated the problem with preserved, generic artificial tears. A few months ago, a 42-year-old woman who worked nights as a nurse came to me with a complex case.

History and complaint: The patient had a history of autoimmune diseases, hypothyroidism, and Lyme disease. She was taking multiple medications. She complained of, redness, tearing, irritation, burning, and blurred vision with shadowing. She told me she was using store-brand artificial tears 5-6 times per day, but they stung her eyes on instillation and didn’t improve her symptoms.

Exam and testing: During the slit lamp exam, I noted meibomian gland dysfunction (MGD), collarettes, lash breakage and dropout, and a foamy tear film. Her conjunctiva was quiet and white, but the cornea showed inferior punctate keratitis OU. There was a pterygium with fibrosis nasally, and a Salzmann nodule adjacent to the pterygium. Examination of the left eye was similar. The vision with her current glasses was 20/25 OU.

Topography showed irregular astigmatism, with placido rings demonstrating irregular mires, superonasal distortion OD, and mildly irregular mires OS. Her tear osmolarity was 304 OD and 293 OS. Meibography showed moderate truncation and tortuosity of glands OU with mild dropout. Her Schirmer’s test without anesthesia was 12mm OD and 9mm OS.

Diagnosis: I diagnosed the patient with mixed etiology DED and demodex blepharitis. MGD was clear from the slit lamp exam and meibography. The severity of her symptoms and the slit lamp findings as well as her underlying autoimmune disease support aqueous deficient DED being at work here as well.

Treatments: I directed the patient to stop using generic eye drops immediately. I explained preservatives and unknown ingredients in the generic drops placed on the eyes 5-6 times per day had actually been making her condition worse, contributing to corneal cell loss (staining). I started her on iVIZIA (Thea) preservative-free povidone/trehalose/HA artificial tears four times a day and more often if needed. I explained that, unlike the generic artificial tears, iVIZIA tears would feel good and provide fast, long-lasting relief and lubrication, reducing inflammation and allowing her eyes to heal.

She began performing twice-daily lid hygiene with tea tree oil cleanser for the demodex and using an immunomodulator to increase tear production and treat inflammation. I instructed her on doing blinking exercises throughout the day and recommended she stop using fans, get a humidifier, and talk to her employer about switching to the day shift to allow for more regulated sleep patterns.

Results: At our 6-week follow-up, the patient reported significant improvement in discomfort and redness with less vision fluctuation. She noted exacerbation of her symptoms one day per week and was able to manage them successfully by increasing use of iVIZIA artificial tears during those times (an experience she noted was dramatically different from her using store-brand tears). Stopping the preserved generic eye drops and starting iVIZIA along with the rest of the regimen allowed the ocular surface to heal. On exam, her vision with the original glasses returned to 20/20 OU, and the astigmatism had become regular, giving her less shadowing with her glasses.

I see many cases just like this one where generic eye drops have turned DED into an acute problem, which can be resolved with a high-quality, brand-name, preservative-free artificial tear. They underscore the importance of recommending specific artificial tears and educating patients about the risks that exist in the eye drop aisle, ranging from reformulated generic products to the dangerous potential for poorly regulated manufacturing.

Lisa K. Feulner, MD, PhD, practices at Advanced Eye Care in Harford County, Maryland. Disclosures: Aldeyra Therapeutics, Allergan/Abbvie, Bruder, Bausch & Lomb, Kala, Novaliq, Novartis, Oyster Point Pharmaceuticals, Science Based Health, Sun Pharmaceuticals, Tarsus Pharmaceuticals, Thea