Clinical study demonstrates impressive symptom relief for patients with evaporative dry eye disease
By Cheryl Guttman Krader
Cologne, Germany-Results of an observational study support the efficacy and safety of a novel ocular lubricant (NovaTears, Novaliq) for providing objective and subjective improvement in patients with mild-to-moderate evaporative dry eye disease (DES).
The F6H8 based product is commercially available in Europe. It is a preservative-free solution provided in a multidose container and is non-blurring.
In the observational study, 30 patients were instructed to instill the drops four times daily. They were allowed to use other artificial tears as needed and were followed for changes in signs and symptoms of their disease.
The ocular lubricant was well tolerated overall, although treatment-related adverse events of stinging and burning caused three patients to withdraw from the study. Efficacy assessments showed that most patients stopped using any other artificial tears, and values for the Ocular Surface Disease Index (OSDI), Schirmer test scores, tear film breakup time (TFBUT), and corneal staining were all significantly improved, reported Philipp Steven, MD, PhD, principal investigator.
“The change in OSDI achieved with use of this novel agent was particularly remarkable as it decreased by an average of almost 30 points overall and by 40 to 80 points in some patients. In trials of other ocular lubricants, the OSDI generally changes by no more than 10 points, and in treating approximately a thousand patients annually for dry eye, I have never seen such a consistent and dramatic decrease in the OSDI,” said Dr. Steven, Department of Ophthalmology, Director Ocular Surface Group and Ocular GvHD Competence Center, University of Cologne, Germany. “Now, having expanded use of this product in my practice over the last 6 months, I can report that overall patient satisfaction is extremely high.”
Dr. Steven noted that the solution has a long residence time on the ocular surface, and that characteristic makes it attractive for use as an ocular lubricant. In contrast to oil-based drops and ointments, it has excellent spreading and wetting characteristics.
“When a drop of (the ocular lubricant) is placed onto a flat surface, it rapidly spreads to form a thin film. With our analytical techniques, we have observed that it mixes immediately with the lipid layer of the tear film as it spreads on the ocular surface,” said Dr. Steven. “Patients who used (the lubricant) ocular lubricant almost universally describe experiencing a very pleasant, velvety or silk-like feeling after dosing, along with immediate relief of dry eye symptoms.”
Dr. Steven said the patient reports could be explained by reduction of mechanical stress occurring when the lid closes over the cornea during a blink. He and his colleagues are hypothesizing that the observation of improved TFBUT associated with the use of the SFA-based ocular lubricant is probably related to rearrangement of the ocular surface lipid layer.
“As the product is lipophilic, it likely interacts with the lipids that are present on the ocular surface, resulting in a positive alteration of the lipid layer,” Dr. Steven explained.
He also postulated an explanation for the significant increase in Schirmers test scores associated with use of the F6H8 ocular lubricant.
“We think that there is reduced tear film evaporation leading to a decrease in ocular surface stress and inflammation and therefore an increase in nerve-regulated tear production,” Dr. Steven said.
Tear film osmolarity was also measured in the observational study, and while it decreased, the change was not statistically significant.
“The relevance of tear film osmolarity as a measure of dry eye severity is a subject of debate,” Dr. Steven said.
Philipp Steven, MD, PhD
Dr. Steven receives research funding from Novaliq.