Status:
COMPLETED
Liposomal Sirolimus in Dry Eye Disease
Lead Sponsor:
Instituto de Oftalmología Fundación Conde de Valenciana
Conditions:
Dry Eye
Eligibility:
All Genders
18-70 years
Phase:
EARLY_PHASE1
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 numbe...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 2 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2020
Estimated Enrollment :
52 Patients enrolled
Trial Details
Trial ID
NCT04115800
Start Date
October 2 2019
End Date
August 1 2020
Last Update
February 10 2021
Active Locations (1)
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1
Instituto de Oftalmología
Mexico City, Mexico, 06800