Dry eyes is a common condition that affects 10–15% of all adults and the prevalence increases with age. The cause of dry eye symptoms can be various diseases but there can also be other contributing factors. Foundation members Jan-Erik Juto and Fredrik Källmark concluded that INMEST could potentially function as a treatment for DED, which led to the initiation of a study.
Dry eye pilot study
In 2018, a randomized double-blind study led by Fredrik Källmark was started at the Källmark Clinic. A total of 36 patients were initially included. Half of the patients received the real treatment and half received a placebo treatment three times a week for two weeks.
An analysis showed promising results for the group that received active treatment, which is why it was decided that the entire group would receive 6 more treatments, so that all patients would receive at least 6 active treatments each. The study was expanded and ultimately 43 patients were included, of which 35 completed during 2018–2019.
New analysis of data showed enhanced efficacy after increasing the number of patients and extending the treatment period with INMEST. A decision was made to increase the number of patients to 100. The amendment application was submitted to the ethics committee and approved. However, the Covid-19 pandemic meant that the expanded study could only be started in the fall of 2021 and completed in 2022. A total of 72 patients were included, of which 65 completed the study.
The results show that INMEST on 6 occasions reduced dry eye symptoms and that the effect was enhanced after 12 treatments. As measured by the primary outcome variable (Ocular Surface Disease Index, OSDI), symptoms were reduced by an average of 40% after four weeks of regular INMEST. The study is not published.
Dry eye follow-up study
In a larger new study, led by Abilion Medical Systems AB, patients with dry eyes were included where they were treated regularly with INMEST at home. The study is double-blind, randomized, placebo-controlled. The study was conducted at various clinics focused on the treatment of dry eyes in Sweden and Denmark. The study is therefore approved by the Swedish Medical Products Agency and ethics committees in both Sweden and Denmark.
The INMEST Foundation is co-funding this study, which includes approximately 100 patients and has been ongoing since autumn 2023. Half of the patients are treated with INMEST and half with placebo three times a week for six weeks. Follow-up ends three months after the last treatment. The study is no longer recruiting more patients and publication of the results is preliminary planned for spring 2025.