Analysis of top-selling US OTC eye care products

Many of the most popular eye care products, such as tears for dry eye, contain allergens and cause serious adverse effects. A key message to physicians and consumers is that the prices, ratings, and marketing claims do not predict the products’ safety, according to first author Natan Hekmatjah, MD, who presented his data at the 2026 EnVision Summit in Puerto Rico, February 13-16. He is a resident at the Feinberg School of Medicine, Northwestern University, Chicago.

“Recent recalls of eye care products have raised safety and regulatory concerns in the over-the-counter (OTC) eye care market. Although the FDA regulates active ingredients, it does not provide guidance on preservatives or allergens,” he said.

While eye care providers advise patients to use these products, limited safety data is available.

Hekmatjah and colleagues conducted a study in which they collected and analyzed 100 popular products for the products’ characteristics, such as price, size, and country of origin; consumer ratings; marketing claims; and lists of ingredients. The information was collected from Amazon, companies’ websites, and NIH DailyMed.

The investigators used the American Contact Dermatitis Society and North American Contact Dermatitis Group data to identify allergens in the products. Any product recalls and adverse events reported by healthcare professionals were obtained from the FDA and FDA Adverse Event Reporting System.

What the study found

Hekmatjah and colleagues reported two key findings: 37% of the products investigated had had at least one adverse event reported by health care professionals, and 89% of those were associated with at least one serious adverse event. One product had been recalled.

Allergens were found in 52% of the products. These included benzalkonium chloride in 23%, propylene glycol in 15%, and polysorbate 80 in 11%.

The study also showed that the products’ price per ounce was not associated with the presence of allergens, the number of reviews, or the unadjusted Amazon ratings; a higher price per ounce was associated with higher adjusted ratings after adjusting for fake reviews.

No association was seen between the adverse events and the characteristics, country of origin, marketing claims, or the consumer rating, and the presence and number of allergens were not associated with characteristics, pricing, marketing claims, or ratings, Nekmatjah reported.

The key study takeaways, according to Nekmatjah, were that “price, ratings, and marketing claims do not predict safety and that many top-selling eye care products contain allergens and are associated with serious adverse events.”

He and his colleagues advised that improved guidance on preservatives and allergens is needed from the FDA, as well as transparent review systems and an accessible safety database that can support evidence-based recommendations for patients.

Hekmatjah was joined in this study by David N. Younessi, MD; John C. Lin, ScB; Sai S. Kurapati, MS; Sophia Neman, MD; and Timothy Janetos, MD, MBA.