Liposomal Sirolimus in Dry Eye Disease

Study Overview
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Brief Summary
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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.

Official Title
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Subconjunctival Treatment of Liposomal Sirolimus as a Treatment for Dry Eye Disease

Conditions
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Dry Eye

Intervention / Treatment
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* Drug: Liposomal Sirolimus


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects with moderate or severe Dry Eye Subjects with OSDI score > 22 Subjects with Van Bijsterveld staining score >4 Subjects that accept to participate in the study Exclusion Criteria: Subjects with refraction surgery antecedents Subjects with ophthalmic surgery six months previous to the study Subjects with Lagophthalmos Subjects with facial paralysis antecedents Subjects with herpetic keratitis Subjects using isotretinoin Pregnant subjects Subjects in lactating period Subjects with allergy or intolerant to the drug Subjects with hepatic disorders Subjects with abnormal thoracic X rays

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Liposomal Sirolimus<br>Subconjunctival injections of liposomal sirolimus in patients with conventional treatment with moderate and severe dry deye disease | Drug: Liposomal Sirolimus<br>* Subconjunctival injections of liposomal sirolimus in patients with conventional treatment with moderate and severe dry deye disease<br>|
| Placebo Comparator: Liposomal<br>Subconjunctival liposomal injections in patients with conventional treatments and moderate and severe dry eye disease | Drug: Liposomal Sirolimus<br>* Subconjunctival injections of liposomal sirolimus in patients with conventional treatment with moderate and severe dry deye disease<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ocular Surface Disease Index (OSDI) | The OSDI is assessed on a scale of 0 to 100, with higher scores representing greater disability. The index demonstrates sensitivity and specificity in distinguishing between normal patients and patients with dry eye disease. The OSDI is a valid and reliable instrument for measuring dry eye disease severity (normal, mild to moderate, and sever) and effect on vision -related function. | Six weeks after intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sirolimus, Liposomal, Subconjunctival