Liposomal Sirolimus in Dry Eye Disease

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

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.

Study Overview

• Status: Completed
• Conditions: Dry Eye
• Intervention / Treatment: Drug: Liposomal Sirolimus

• Study Type: Interventional
• Enrollment (Actual): 52
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• Mexico
  • Mexico City, Mexico, 06800
    • Instituto de Oftalmología

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Instituto de Oftalmología Fundación Conde de Valenciana

Study record dates

Study Major Dates

• Study Start (Actual): October 2, 2019
• Primary Completion (Actual): May 1, 2020
• Study Completion (Actual): August 1, 2020

Study Registration Dates

• First Submitted: October 2, 2019
• First Submitted That Met QC Criteria: October 2, 2019
• First Posted (Actual): October 4, 2019

Study Record Updates

• Last Update Posted (Actual): February 10, 2021
• Last Update Submitted That Met QC Criteria: February 9, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: Sirolimus; Liposomal; Subconjunctival
• Additional Relevant MeSH Terms: Lacrimal Apparatus Diseases; Keratoconjunctivitis; Conjunctivitis; Conjunctival Diseases; Keratitis; Corneal Diseases; Eye Diseases; Dry Eye Syndromes; Keratoconjunctivitis Sicca; Physiological Effects of Drugs; Anti-Infective Agents; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Anti-Bacterial Agents; Antibiotics, Antineoplastic; Antifungal Agents; Sirolimus
• Other Study ID Numbers: CEI-2019/04/01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No