Liposomal Sirolimus in Dry Eye Disease

Sponsor

Instituto de Oftalmología Fundación Conde de Valenciana (Other)

Overall Status

Completed

CT.gov ID

NCT04115800

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

5.2

Patients Per Site Per Month

Study Details

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

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 :

Oct 2, 2019

Actual Primary Completion Date :

May 1, 2020

Actual Study Completion Date :

Aug 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

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

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Instituto de Oftalmología	Mexico City		Mexico	06800

Sponsors and Collaborators

Instituto de Oftalmología Fundación Conde de Valenciana

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Instituto de Oftalmología Fundación Conde de Valenciana

ClinicalTrials.gov Identifier:

NCT04115800

Other Study ID Numbers:

CEI-2019/04/01

First Posted:

Oct 4, 2019

Last Update Posted:

Feb 10, 2021

Last Verified:

Feb 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Instituto de Oftalmología Fundación Conde de Valenciana

Sirolimus

Liposomal

Subconjunctival

Additional relevant MeSH terms:

Dry Eye Syndromes

Keratoconjunctivitis Sicca

Eye Diseases

Sirolimus

Study Results

No Results Posted as of Feb 10, 2021