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

NCT ID: NCT02403219

Last Updated: 2015-03-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-05-31
• Study Completion Date: 2015-01-31

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Botulinum toxin type A injection

Intervention Type: DRUG

Injection of botulinum toxin type A

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.

Group Type: SHAM_COMPARATOR

Saline solution injection

Intervention Type: OTHER

Injection of saline solution

Interventions

Botulinum toxin type A injection

Injection of botulinum toxin type A

Intervention Type: DRUG

Saline solution injection

Injection of saline solution

Intervention Type: OTHER

Other Intervention Names

Botox; Saline solution

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Instituto de Oftalmología Fundación Conde de Valenciana

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Juan Carlos Serna-Ojeda, MD

Role: PRINCIPAL_INVESTIGATOR

Instituto de Oftalmologia Conde de Valenciana

Ángel Nava-Castañeda, MD

Role: STUDY_DIRECTOR

Instituto de Oftalmologia Conde de Valenciana

References

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.

Reference Type: BACKGROUND

PMID: 17508116 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 12488263 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 10764857 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 8890438 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 15808266 (View on PubMed)

Other Identifiers

CEI-2013-/06/06

Identifier Type: -

Identifier Source: org_study_id