Liposomal Sirolimus in Dry Eye Disease

Instituto de Oftalmología Fundación Conde de Valenciana

Status and phase: Completed; Early Phase 1

Conditions: Dry Eye

Treatments: Drug: Liposomal Sirolimus

Study type: Interventional

Funder types: Other

Identifiers

NCT04115800

CEI-2019/04/01

Details and patient eligibility

About

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.

Enrollment: 52 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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52 participants in 2 patient groups, including a placebo group

Liposomal Sirolimus

Experimental group

Description:

Subconjunctival injections of liposomal sirolimus in patients with conventional treatment with moderate and severe dry deye disease

Treatment:

Drug: Liposomal Sirolimus

Liposomal

Placebo Comparator group

Description:

Subconjunctival liposomal injections in patients with conventional treatments and moderate and severe dry eye disease

Treatment:

Drug: Liposomal Sirolimus