NCT02403219

Paralysis of the Orbicularis Muscle of the Eye in the Treatment for Dry Eye

Paralysis of the Orbicularis Muscle of the Eye by Using Botulinum Toxin Type A in the Treatment for Dry Eye

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Instituto de Oftalmología Fundación Conde de Valenciana · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Dry Eye Syndromes

Interventions

Type	Name	Description
DRUG	Botulinum toxin type A injection	Injection of botulinum toxin type A
OTHER	Saline solution injection	Injection of saline solution

Timeline

• Start date: 2013-05-01
• Primary completion: 2014-02-01
• Completion: 2015-01-01
• First posted: 2015-03-31
• Last updated: 2015-03-31