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NCT04115800

Liposomal Sirolimus in Dry Eye Disease

Completed EARLY_PHASE1 Last updated 10 February 2021
What this trial tests

EARLY_PHASE1 trial testing Liposomal Sirolimus in Dry Eye in 52 participants. Completed in 1 August 2020.

Timeline
2 October 2019
Primary endpoint
1 May 2020
1 August 2020

Quick facts

Lead sponsorInstituto de Oftalmología Fundación Conde de Valenciana
PhaseEARLY_PHASE1
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingtriple
Primary purposetreatment
Enrollment52
Start date2 October 2019
Primary completion1 May 2020
Estimated completion1 August 2020
Sites1 location across Mexico

Drugs / interventions tested

Conditions studied

Sponsor

Instituto de Oftalmología Fundación Conde de Valenciana — full company profile →

Who can join

Adults 18 to 70, any sex, with Dry Eye. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Lipid Nanoparticles as a Promising Drug Delivery Carrier for Topical Ocular Therapy-An Overview on Recent Advances.
    Jacob S, Nair AB, Shah J, Gupta S, et al · · 2022 · cited 72× · PMID 35335909 · DOI 10.3390/pharmaceutics14030533
  2. Subconjunctival Sirolimus-Loaded Liposomes for the Treatment of Moderate-to-Severe Dry Eye Disease.
    Salcedo-Ledesma A, Córdoba A, Zatarain-Barrón NC, Graue-Hernández EO, et al · · 2023 · cited 3× · PMID 37181078 · DOI 10.2147/opth.s405841
  3. Advances in the management of ocular anterior segment diseases using biomaterials-based drug delivery systems.
    Subhash NE, Prabhu M, Hazarika M, S S, et al · · 2026 · cited 2× · PMID 40811684 · DOI 10.1177/08853282251369229
  4. Recent advances and future challenges in nanosystems for ocular drug delivery.
    Shahror RA, Fouda AY. · · 2025 · cited 1× · PMID 41478665 · DOI 10.1016/j.jpet.2025.103738

Verify or expand the search:

Other recruiting trials for Dry Eye

Currently open trials in the same condition.

Other Instituto de Oftalmología Fundación Conde de Valenciana trials

Trials by the same sponsor.

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Data sources for this page

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