Clinical trial NCT02403219: Paralysis of the Orbicularis Muscle of the Eye in the Treatment for Dry Eye
Official title: Paralysis of the Orbicularis Muscle of the Eye by Using Botulinum Toxin Type A in the Treatment for Dry Eye
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Dry Eye Syndromes
Keywords: Dry eye
Botulinum toxin A
Orbicularis muscle of the eye
Lead sponsor: Instituto de Oftalmología Fundación Conde de Valenciana
Sponsor class: OTHER
First posted: 2015-03-31
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Symptoms of dry eye (questionnaire)
timeFrame: 6 months
measure: Symptoms of conjunctivitis (questionnaire)
timeFrame: 6 months
measure: Quality of vision (graded perception of patient)
timeFrame: 6 months
measure: Ocular comfort level (graded perception of patient)
timeFrame: 6 months
measure: 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)
timeFrame: 6 months
measure: Visual acuity (Snellen vision acuity)
timeFrame: 6 months
measure: 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)
timeFrame: 6 months
measure: Schirmer's test
timeFrame: 6 months
measure: Oxford grading scheme for corneal and conjunctival staining
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Instituto de Oftalmologia Conde de Valenciana
name: Juan Carlos Serna-Ojeda, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Instituto de Oftalmologia Conde de Valenciana
name: Ángel Nava-Castañeda, MD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.