Paralysis of the Orbicularis Muscle of the Eye in the Treatment for Dry Eye
Status:
Completed
Trial end date:
2015-01-01
Target enrollment:
Participant gender:
Summary
This is a prospective, comparative, contralateral eye study. Patients older than 18 years who
have had treatment with topical lubricants for at least 1 month and persist with symptoms of
dry eye and corneal staining with fluorescein were included. Patients with dry eye
attributable to abnormalities of the eyelids, nasolacrimal obstruction and active corneal
infection, as well as patients with severe dry eye were excluded from the study. One eye
randomly received a subcutaneous injection of botulinum toxin in the medial part of the lower
eyelid, and the other eye received a similar procedure with placebo. The subjective
evaluation was achieved with a questionnaire assessing symptoms of dry eye and
conjunctivitis, quality of vision and ocular comfort level each eye separately. The objective
evaluation included the measurement of the tear film break up time, Schirmer's test and with
a modification of the Oxford grading scheme for corneal and conjunctival staining.
Phase:
Phase 1
Details
Lead Sponsor:
Instituto de Oftalmología Fundación Conde de Valenciana
Treatments:
abobotulinumtoxinA Botulinum Toxins Botulinum Toxins, Type A incobotulinumtoxinA onabotulinumtoxinA Pharmaceutical Solutions