Dry eye disease is a very frequent pathology that importantly affects the quality of life of
patients; in spite of the common use of eye lubricants to ameliorate symptoms, there is still
a large number of patients who do not present improvement of the disease or they worsen.
Although its etiology is varied, the imbalance of the immune system plays a substantial role
in the development of dry eye disease. Rapamycin or sirolimus is an anti-inflammatory and
immunomodulatory drug that has an enormous potential in ocular surface pathologies such as
dry eye disease. The aim of the present study is to determine the effectiveness and security
of subconjunctival application of a new formulated drug of liposomal sirolimus in patients
with moderate and severe dry eye disease. This is a randomized placebo-controlled double
blind clinical trial. Patients presenting data of moderate or severe dry eye disease will be
randomized into two groups. One group will receive additional to the conventional treatment,
subconjunctival injections of liposomal sirolimus; meanwhile the other group will receive
subconjunctival placebo injections. After intervention the effectiveness and the security of
the liposomal sirolimus will be evaluated.
Phase:
Early Phase 1
Details
Lead Sponsor:
Instituto de Oftalmología Fundación Conde de Valenciana