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

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ClinicalTrials.gov Identifier: NCT02403219
Recruitment Status : Completed
First Posted : March 31, 2015
Last Update Posted : March 31, 2015
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Dry Eye Syndromes Drug: Botulinum toxin type A injection Other: Saline solution injection Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Paralysis of the Orbicularis Muscle of the Eye by Using Botulinum Toxin Type A in the Treatment for Dry Eye
Study Start Date : May 2013
Actual Primary Completion Date : February 2014
Actual Study Completion Date : January 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Botox Paralysis

Arm Intervention/treatment
Experimental: 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.
Drug: Botulinum toxin type A injection
Injection of botulinum toxin type A
Other Name: Botox

Sham Comparator: Sham 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.
Other: Saline solution injection
Injection of saline solution
Other Name: Saline solution




Primary Outcome Measures :
  1. Symptoms of dry eye (questionnaire) [ Time Frame: 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.

  2. Symptoms of conjunctivitis (questionnaire) [ Time Frame: 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.

  3. Quality of vision (graded perception of patient) [ Time Frame: 6 months ]
    The quality of vision will be graded from 0 to 5 according to the perception of the patient.

  4. Ocular comfort level (graded perception of patient) [ Time Frame: 6 months ]
    The ocular comfort level will be graded from 0 to 5 according to the perception of the patient.

  5. 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) [ Time Frame: 6 months ]
    The

  6. Visual acuity (Snellen vision acuity) [ Time Frame: 6 months ]
    Snellen vision acuity

  7. 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) [ Time Frame: 6 months ]
    After fluorescein staining, the time required for dry spots to appear on the corneal surface after blinking will be recorded in seconds.

  8. Schirmer's test [ Time Frame: 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.

  9. Oxford grading scheme for corneal and conjunctival staining [ Time Frame: 6 months ]
    After fluorescein staining, the corneal and conjunctival staining will be graded according to severity from 0 to 5.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02403219


Sponsors and Collaborators
Instituto de Oftalmología Fundación Conde de Valenciana
Investigators
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Principal Investigator: Juan Carlos Serna-Ojeda, MD Instituto de Oftalmologia Conde de Valenciana
Study Director: Ángel Nava-Castañeda, MD Instituto de Oftalmologia Conde de Valenciana

Publications:
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Responsible Party: Instituto de Oftalmología Fundación Conde de Valenciana
ClinicalTrials.gov Identifier: NCT02403219     History of Changes
Other Study ID Numbers: CEI-2013-/06/06
First Posted: March 31, 2015    Key Record Dates
Last Update Posted: March 31, 2015
Last Verified: March 2015

Keywords provided by Instituto de Oftalmología Fundación Conde de Valenciana:
Dry eye
Botulinum toxin A
Orbicularis muscle of the eye

Additional relevant MeSH terms:
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Keratoconjunctivitis Sicca
Dry Eye Syndromes
Eye Diseases
Paralysis
Keratoconjunctivitis
Conjunctivitis
Conjunctival Diseases
Keratitis
Corneal Diseases
Lacrimal Apparatus Diseases
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Pharmaceutical Solutions
Botulinum Toxins
Botulinum Toxins, Type A
abobotulinumtoxinA
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Neuromuscular Agents
Peripheral Nervous System Agents