Liposomal Sirolimus in Dry Eye Disease

NCT ID: NCT04115800

Last Updated: 2021-02-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 52 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-10-02
• Study Completion Date: 2020-08-01

Brief Summary

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.

Conditions

Dry Eye

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Liposomal Sirolimus

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

Group Type: EXPERIMENTAL

Liposomal Sirolimus

Intervention Type: DRUG

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

Liposomal

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

Group Type: PLACEBO_COMPARATOR

Liposomal Sirolimus

Intervention Type: DRUG

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

Interventions

Liposomal Sirolimus

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

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Instituto de Oftalmología Fundación Conde de Valenciana

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Instituto de Oftalmología

Mexico City, , Mexico

Countries

Mexico

Other Identifiers

CEI-2019/04/01

Identifier Type: -

Identifier Source: org_study_id