Liposomal Sirolimus in Dry Eye Disease

• ClinicalTrials.gov Identifier: NCT04115800
• Recruitment Status: Completed
• First Posted: October 4, 2019
• Last Update Posted: February 10, 2021
• Sponsor: Instituto de Oftalmología Fundación Conde de Valenciana
• Information provided by (Responsible Party): Instituto de Oftalmología Fundación Conde de Valenciana

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Dry Eye	Drug: Liposomal Sirolimus	Early Phase 1

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 52 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Treatment
• Official Title: Subconjunctival Treatment of Liposomal Sirolimus as a Treatment for Dry Eye Disease
• Actual Study Start Date: October 2, 2019
• Actual Primary Completion Date: May 1, 2020
• Actual Study Completion Date: August 1, 2020

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. Ocular Surface Disease Index (OSDI) [ Time Frame: 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.

Eligibility Criteria

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

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

Contacts and Locations

Locations

Mexico

Instituto de Oftalmología

Mexico City, Mexico, 06800

Sponsors and Collaborators

Instituto de Oftalmología Fundación Conde de Valenciana

More Information

• Responsible Party: Instituto de Oftalmología Fundación Conde de Valenciana
• ClinicalTrials.gov Identifier: NCT04115800
• Other Study ID Numbers: CEI-2019/04/01
• First Posted: October 4, 2019
• Last Update Posted: February 10, 2021
• Last Verified: February 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Instituto de Oftalmología Fundación Conde de Valenciana:

Sirolimus; Liposomal; Subconjunctival

Additional relevant MeSH terms:

Dry Eye Syndromes; Keratoconjunctivitis Sicca; Eye Diseases; Lacrimal Apparatus Diseases; Keratoconjunctivitis; Conjunctivitis; Conjunctival Diseases; Keratitis; Corneal Diseases; Sirolimus; Anti-Bacterial Agents; Anti-Infective Agents; Antibiotics, Antineoplastic; Antineoplastic Agents; Antifungal Agents; Immunosuppressive Agents; Immunologic Factors; Physiological Effects of Drugs