A novel lubricant eye drop that specifically targets tear film evaporation in dry eye disease seems safe and effective for treating mild-to-moderate evaporative disease.
Take-home message: A new lubricant eye drop that specifically targets tear film evaporation in dry eye disease seems safe and effective for treating mild to moderate evaporative disease.
Reviewed by Philipp Steven, MD
Cologne, Germany-A novel lubricant eye drop that specifically targets tear film evaporation seems to be safe and effective in treating mild-to-moderate hyperevaporative dry eye disease.
The product, perfluorohexyloctane, or F6H8 (NovaTears, Novaliq), improved four of five parameters studied, especially the Ocular Surface Disease Index (OSDI). The non-preserved formulation is from the family of semifluorinated alkanes and has been approved by the European Medical Device Directive as a medical device with a nonblurring wetting agent for the ocular surface.
“F6H8 represents a groundbreaking water-free concept for treatment of evaporative dry-eye disease through outstanding spreading properties and eligible biocompatibility,” said Philipp Steven, MD, principle investigator of the Ocular Surface Group, Department of Ophthalmology, and director of the Ocular GvHD Competence Center, University of Cologne, Cologne, Germany.
Dr. Steven and his team conducted a prospective, two-center, observational 6-week study of 30 patients from two dry eye outpatient clinics-the University of Cologne and the Augenarztpraxis Heidelberg-who were instructed to instill one drop of F6H8 four times a day in both eyes.
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The objective of the study was to determine if the formulation could stabilize the tear film and relieve symptoms of dry eye. Investigators evaluated the effect of F6H8 on best-corrected visual acuity (BCVA), IOP, Schirmer I test results, tear fluid osmolarity, tear film break-up time (TFBUT), corneal staining, meibum secretion, and the OSDI. Patients were asked to complete a questionnaire at the end of the study to measure the product usability and patient satisfaction, Dr. Steven noted.
Twenty-five patients completed the study according to the study protocol. Investigators found that BCVA and IOP were unaffected by F6H8. Interestingly, tear osmolarity decreased significantly only in the right eyes.
The Schirmer I test results and TFBUT both increased significantly during the study, reflecting the improved tear secretion and tear film stability. The OSDI decreased significantly from 55 to 34, which indicated decreased severity of the subjective symptoms. Corneal staining also decreased significantly after five to seven weeks. Finally, the meibum quality improved in seven patients, according to Dr. Steven.
Most questionnaire responses from patients were “very positive” regarding use of the drug and symptom relief.
F6H8 appeared to be very safe. Five adverse effects were reported during the study, none of which were considered serious. Three patients reported mild to moderate hypersensitivity to F6H8. One patient reported recurrent rheumatoid arthritis, which was probably not related to the drug, and discontinued use of F6H8.
Investigators reported their findings in the Journal of Ocular Pharmacology and Therapeutics (J Ocul Pharmacol Ther. 2015;31:498-503).
“This prospective observational study shows significant beneficial effects in patients suffering from evaporative dry eye disease, using F6H8 in all the relevant parameters tested,” the investigators concluded. “The decrease of the OSDI by a mean of 21 points was particularly remarkable and clearly exceeds minimal, clinical important differences for mild or moderate and severe disease. Overall, F6H8 seems to be safe and effective in treating mild to moderate hyperevaporative dry eye disease.”
Philipp Steven, MD
The study was supported by Novaliq GmbH. Dr. Steven reported receiving grants from the company.