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

Dry Eye Syndromes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02403219
• Other study ID #: CEI-2013-/06/06
• Status: Completed
• Phase: Phase 1
• First received: January 21, 2015
• Last updated: March 30, 2015
• Start date: May 2013
• Est. completion date: January 2015

Study information

• Verified date: March 2015
• Source: Instituto de Oftalmología Fundación Conde de Valenciana
• Contact: n/a
• Is FDA regulated: No
• Health authority: Mexico: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: January 2015
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dry Eye Syndromes
• Keratoconjunctivitis Sicca

Intervention

Drug:
• Botulinum toxin type A injection
Injection of botulinum toxin type A

Other:
• Saline solution injection
Injection of saline solution

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Instituto de Oftalmología Fundación Conde de Valenciana

References & Publications (5)

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. — View 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. — View Citation

Reifler DM. Early descriptions of Horner's muscle and the lacrimal pump. Surv Ophthalmol. 1996 Sep-Oct;41(2):127-34. — View 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. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	Visual acuity (Snellen vision acuity)	Snellen vision acuity	6 months	No
Primary	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	No
Primary	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	No
Primary	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	No