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

NCT02403219 | Completed Phase 1 DMC

• 1 other identifier: CEI-2013-/06/06
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Dry Eye Syndromes

Keywords

Dry eye; Botulinum toxin A; Orbicularis muscle of the eye

Outcome Measures

Primary Outcomes (9)

• 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

Study Arms (2)

Botulinum toxin type A injection

EXPERIMENTAL

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

Sham injection

SHAM COMPARATOR

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

Interventions

Botulinum toxin type A injection DRUG

Injection of botulinum toxin type A

Also known as: Botox

Botulinum toxin type A injection

Saline solution injection OTHER

Injection of saline solution

Also known as: Saline solution

Sham injection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Instituto de Oftalmología Fundación Conde de Valenciana: lead

Related Publications (5)

• The definition and classification of dry eye disease: report of the Definition and Classification Subcommittee of the International Dry Eye WorkShop (2007). Ocul Surf. 2007 Apr;5(2):75-92. doi: 10.1016/s1542-0124(12)70081-2.

  PMID: 17508116 BACKGROUND

• Horwath-Winter J, Bergloeff J, Floegel I, Haller-Schober EM, Schmut O. Botulinum toxin A treatment in patients suffering from blepharospasm and dry eye. Br J Ophthalmol. 2003 Jan;87(1):54-6. doi: 10.1136/bjo.87.1.54.

  PMID: 12488263 BACKGROUND

• Sahlin S, Chen E, Kaugesaar T, Almqvist H, Kjellberg K, Lennerstrand G. Effect of eyelid botulinum toxin injection on lacrimal drainage. Am J Ophthalmol. 2000 Apr;129(4):481-6. doi: 10.1016/s0002-9394(99)00408-0.

  PMID: 10764857 BACKGROUND

• Reifler DM. Early descriptions of Horner's muscle and the lacrimal pump. Surv Ophthalmol. 1996 Sep-Oct;41(2):127-34. doi: 10.1016/s0039-6257(96)80002-6.

  PMID: 8890438 BACKGROUND

• Kakizaki H, Zako M, Miyaishi O, Nakano T, Asamoto K, Iwaki M. The lacrimal canaliculus and sac bordered by the Horner's muscle form the functional lacrimal drainage system. Ophthalmology. 2005 Apr;112(4):710-6. doi: 10.1016/j.ophtha.2004.11.043.

  PMID: 15808266 BACKGROUND

MeSH Terms

Conditions

Dry Eye Syndromes

Interventions

Botulinum Toxins, Type A; Saline Solution

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Juan Carlos Serna-Ojeda, MD

  Instituto de Oftalmologia Conde de Valenciana

  PRINCIPAL INVESTIGATOR

• Ángel Nava-Castañeda, MD

  Instituto de Oftalmologia Conde de Valenciana

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 21, 2015
• First Posted: March 31, 2015
• Study Start: May 1, 2013
• Primary Completion: February 1, 2014
• Study Completion: January 1, 2015
• Last Updated: March 31, 2015

Record last verified: 2015-03