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Liposomal Sirolimus in Dry Eye Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04115800
Recruitment Status : Completed
First Posted : October 4, 2019
Last Update Posted : February 10, 2021
Sponsor:
Information provided by (Responsible Party):
Instituto de Oftalmología Fundación Conde de Valenciana

Tracking Information
First Submitted Date  ICMJE October 2, 2019
First Posted Date  ICMJE October 4, 2019
Last Update Posted Date February 10, 2021
Actual Study Start Date  ICMJE October 2, 2019
Actual Primary Completion Date May 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 2, 2019)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Liposomal Sirolimus in Dry Eye Disease
Official Title  ICMJE Subconjunctival Treatment of Liposomal Sirolimus as a Treatment for Dry Eye Disease
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Early Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Dry Eye
Intervention  ICMJE Drug: Liposomal Sirolimus
Subconjunctival injections of liposomal sirolimus in patients with conventional treatment with moderate and severe dry deye disease
Study Arms  ICMJE
  • Experimental: Liposomal Sirolimus
    Subconjunctival injections of liposomal sirolimus in patients with conventional treatment with moderate and severe dry deye disease
    Intervention: Drug: Liposomal Sirolimus
  • Placebo Comparator: Liposomal
    Subconjunctival liposomal injections in patients with conventional treatments and moderate and severe dry eye disease
    Intervention: Drug: Liposomal Sirolimus
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 2, 2019)
52
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 1, 2020
Actual Primary Completion Date May 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Mexico
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04115800
Other Study ID Numbers  ICMJE CEI-2019/04/01
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Current Responsible Party Instituto de Oftalmología Fundación Conde de Valenciana
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Instituto de Oftalmología Fundación Conde de Valenciana
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Instituto de Oftalmología Fundación Conde de Valenciana
Verification Date February 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP