Liposomal Sirolimus in Dry Eye Disease

NCT04115800 | Completed Early Phase 1

• 1 other identifier: CEI-2019/04/01
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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

Keywords

Sirolimus; Liposomal; Subconjunctival

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Liposomal Sirolimus

EXPERIMENTAL

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

Drug: Liposomal Sirolimus

Liposomal

PLACEBO COMPARATOR

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

Drug: Liposomal Sirolimus

Interventions

Liposomal Sirolimus DRUG

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

Liposomal; Liposomal Sirolimus

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Instituto de Oftalmología Fundación Conde de Valenciana: lead

Study Sites (1)

Instituto de Oftalmología

Mexico City, 06800, Mexico

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 2, 2019
• First Posted: October 4, 2019
• Study Start: October 2, 2019
• Primary Completion: May 1, 2020
• Study Completion: August 1, 2020
• Last Updated: February 10, 2021

Record last verified: 2021-02

Locations

ME (1)