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

Instituto de Oftalmología Fundación Conde de Valenciana

Status and phase: Completed; Phase 1

Conditions: Dry Eye Syndromes

Treatments: Drug: Botulinum toxin type A injection; Other: Saline solution injection

Study type: Interventional

Funder types: Other

Identifiers

NCT02403219

CEI-2013-/06/06

Details and patient eligibility

About

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.

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Treatment with topical lubricants for at least 1 month and persist with symptoms of dry eye and corneal staining with fluorescein.

Exclusion criteria

• Dry eye patients attributable to abnormalities of the eyelids (problems with the mechanism of blinking, poor eyelid position, changes in position or structure of the eyelashes, high surface lesions, etc.)
• Nasolacrimal obstruction.
• Active corneal infection.
• Patients with severe grade 4 dry eye.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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20 participants in 2 patient groups

Botulinum toxin type A injection

Experimental group

Description:

An injection of 4 international units of botulinum toxin type A will be applied in the medial in the medial part of the lower eyelid near the punctum directed along the medial canthal tendon in a single application by subcutaneous injection.

Treatment:

Drug: Botulinum toxin type A injection

Sham injection

Sham Comparator group

Description:

An injection of 4 international units of sham will be applied in the medial in the medial part of the lower eyelid near the punctum directed along the medial canthal tendon in a single application by subcutaneous injection.

Treatment:

Other: Saline solution injection