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Completed

NCT Number: NCT02403219

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

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.

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Key information

Conditions

Dry Eye Syndromes Eye Diseases Lacrimal Apparatus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Botulinum toxin type A injection

Drug

Injection of botulinum toxin type A

Other names: Botox

Saline solution injection

Other

Injection of saline solution

Other names: Saline solution

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Instituto de Oftalmología Fundación Conde de Valenciana

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2014
Study completion
2015
First posted
Mar 31, 2015
Registry last updated
Mar 31, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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