Liposomal Sirolimus in Dry Eye Disease

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

Status

Completed

Phases

Early Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04115800

Enrollment

Registered

2019-10-04

Start date

2019-10-02

Completion date

2020-08-01

Last updated

2021-02-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dry Eye

Keywords

Sirolimus, Liposomal, Subconjunctival

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.

Interventions

DRUGLiposomal Sirolimus

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

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

Design outcomes

Primary

Measure	Time frame	Description
Ocular Surface Disease Index (OSDI)	Six weeks after intervention	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.

Countries

Mexico

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026