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

Study Overview
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Brief Summary
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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.

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

Conditions
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Dry Eye Syndromes

Intervention / Treatment
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* Drug: Botulinum toxin type A injection
* Other: Saline solution injection


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Botulinum toxin type A injection<br>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. | Drug: Botulinum toxin type A injection<br>* Injection of botulinum toxin type A<br>* Other names: Botox;|
| Sham Comparator: Sham injection<br>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. | Other: Saline solution injection<br>* Injection of saline solution<br>* Other names: Saline solution;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Symptoms of dry eye (questionnaire) | 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. | 6 months | 
| Symptoms of conjunctivitis (questionnaire) | 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. | 6 months | 
| Quality of vision (graded perception of patient) | The quality of vision will be graded from 0 to 5 according to the perception of the patient. | 6 months | 
| Ocular comfort level (graded perception of patient) | The ocular comfort level will be graded from 0 to 5 according to the perception of the patient. | 6 months | 
| 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) | The | 6 months | 
| Visual acuity (Snellen vision acuity) | Snellen vision acuity | 6 months | 
| 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) | After fluorescein staining, the time required for dry spots to appear on the corneal surface after blinking will be recorded in seconds. | 6 months | 
| Schirmer's test | After instillation of topical anesthetic, paper strips are inserted into the conjunctival sac for 5 minutes to measure the production of tears in millimeters. | 6 months | 
| Oxford grading scheme for corneal and conjunctival staining | After fluorescein staining, the corneal and conjunctival staining will be graded according to severity from 0 to 5. | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dry eye, Botulinum toxin A, Orbicularis muscle of the eye