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Dry Eye SyndromesPhase 1NCT02403219

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

A Phase 1 study testing Botulinum toxin type A injection and Saline solution injection in people with Dry Eye Syndromes, run by Instituto de Oftalmología Fundación Conde de Valenciana.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Dry Eye Syndromes
What is being tested?
Botulinum toxin type A injection and Saline solution injection
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
20 participants
Where
No sites listed yet
Study dates
May 2013to Jan 2015
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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.

About this study

Official title: Paralysis of the Orbicularis Muscle of the Eye by Using Botulinum Toxin Type A 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.

Being tested
Botulinum toxin type A injection, Saline solution injection
Keywords
Dry eye, Botulinum toxin A, Orbicularis muscle of the eye
Medical subject headings
Dry Eye Syndromes

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Botulinum toxin type A injectionDrug

    Also called Botox

    Injection of botulinum toxin type A

  • Saline solution injectionOther

    Also called Saline solution

    Injection of saline solution

Study groups in NCT02403219
Study groupRoleWhat they receive
Botulinum toxin type A injectionExperimentalAn 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.
Receives: Drug: Botulinum toxin type A injection
Sham injectionSham comparatorAn 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.
Receives: Other: Saline solution injection

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 6 months

  2. 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.

    Measured: 6 months

  3. 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.

    Measured: 6 months

  4. 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.

    Measured: 6 months

  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)

    The

    Measured: 6 months

  6. Visual acuity (Snellen vision acuity)

    Snellen vision acuity

    Measured: 6 months

  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)

    After fluorescein staining, the time required for dry spots to appear on the corneal surface after blinking will be recorded in seconds.

    Measured: 6 months

  8. 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.

    Measured: 6 months

  9. 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.

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Mar 2015 (estimated)
  2. Study startMay 2013
  3. Primary completionFeb 2014
  4. Study completionJan 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
Single blind
Who is masked
Participant
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02403219
Sponsor's protocol ID
CEI-2013-/06/06
Status last verified
Mar 2015
First submitted
21 Jan 2015
Last updated
31 Mar 2015
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 17508116

  • 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.

    PubMed 12488263

  • 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.

    PubMed 10764857

  • 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.

    PubMed 8890438

  • 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.

    PubMed 15808266

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Botulinum toxin type A injection and Saline solution injection in people with Dry Eye Syndromes, run by Instituto de Oftalmología Fundación Conde de Valenciana.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 31 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Symptoms of dry eye (questionnaire) (time frame: 6 months). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02403219, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2015.

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