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

Phase 1

Completed

• Conditions: Dry Eye Syndromes
• Interventions: Drug: Botulinum toxin type A injection; Other: Saline solution injection

• Registration Number: NCT02403219
• Lead Sponsor: Instituto de Oftalmología Fundación Conde de Valenciana

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-05
• Primary Completion: 2014-02
• Study Completion: 2015-01
• Study First Submitted: 2015-01-21
• Status Verified: 2015-03
• Study First Submitted QC: 2015-03-30
• Last Update Submitted: 2015-03-30
• Study First Posted: 2015-03-31
• Last Update Posted: 2015-03-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Botulinum toxin type A injection	Botulinum toxin type A injection	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.
Sham injection	Saline solution injection	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.

Primary Outcome Measures

Name	Time	Method
Symptoms of conjunctivitis (questionnaire)	6 months	A questionnaire assessing symptoms of conjunctivitis eye separately, including redness and discharge. Depending on the frequency, each symptom will be graded from 0 to 5.
Quality of vision (graded perception of patient)	6 months	The quality of vision will be graded from 0 to 5 according to the perception of the patient.
Moisturizing agent usage (patient will be asked how many times a day does he use the moisturizing agent and will be graded from 0 to 5 according to the frequency)	6 months	The
Visual acuity (Snellen vision acuity)	6 months	Snellen vision acuity
Measurement of the tear film break up time (After fluorescein staining, the time required for dry spots to appear on the corneal surface after blinking)	6 months	After fluorescein staining, the time required for dry spots to appear on the corneal surface after blinking will be recorded in seconds.
Oxford grading scheme for corneal and conjunctival staining	6 months	After fluorescein staining, the corneal and conjunctival staining will be graded according to severity from 0 to 5.
Ocular comfort level (graded perception of patient)	6 months	The ocular comfort level will be graded from 0 to 5 according to the perception of the patient.
Schirmer's test	6 months	After instillation of topical anesthetic, paper strips are inserted into the conjunctival sac for 5 minutes to measure the production of tears in millimeters.
Symptoms of dry eye (questionnaire)	6 months	A questionnaire assessing symptoms of dry eye each eye separately, including dryness, watery eyes, itching, burning, foreign body, fluctuating vision and light sensitivity. Depending on the frequency, each symptom will be graded from 0 to 5.