Tears; ExcessPhase 4NCT06080438

Effect of Topical Botulinum Toxin Eyedrop on Palpebral Fissure

A Phase 4 study testing Botulinum toxin in people with Tears; Excess and Eyelid Spasm, run by University of Miami at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

The purpose of this research study is to test if Topical (applied to the surface of the eye) Botulinum Toxin temporarily lowers the upper eyelid and makes the eyelid appear less open and thereby affects the eye surface and decreases reflexive tearing. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Tears; Excess, Eyelid Spasm
What is being tested?: Botulinum toxin
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 2 participants
Where: 1 siteUnited States
Study dates: 29 Nov 2022to 28 Jul 2024
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

Adults aged 18 and above that present to the oculoplastic and reconstructive surgery department that are able to provide informed consent to participate
Presence of upper eyelid retraction or asymmetry( >1mm)

Who cannot join

Adults unable to consent
Individuals less than 18 years of age
Prisoners
Pregnant women. o Patients will be asked if they are pregnant by research staff before participation in the study.
Women who are breast-feeding
Known contradictions or sensitivities to study medication

Show all 16Show fewer

Grossly abnormal lid margins, anatomical abnormalities
Variable ptosis or eyelid position (e.g., myasthenia gravis, blepharospasm)
Any ocular or systemic condition that, in the opinion of the investigator, would confound study data, interfere with the subject's study participation, or affected the subject's safety or trial parameters
Presence of an active ocular infection
Inability to sit comfortably for 15 - 30 minutes
Botulinum toxin injection in the eyelids during the past 3 weeks.
Neuromuscular disorders (e.g., Parkinson's disease or myasthenia gravis)
Medication use known to interfere with the effects of botulinum toxin-A within the previous 1 month (e.g., aminoglycoside or benzodiazepines),
Previous history of hypersensitivity reactions to botulinum toxin-A
Dysfunction of tear production or secretion (e.g., meibomian gland dysfunction or Sjogren's syndrome),

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Miami
Miami, Florida, 33135

Other trials in United States

About this study

Official title: The Effect of Topical Botulinum Toxin Eyedrop on Palpebral Fissure Height, Ocular Surface and Tearing

Conditions: Tears; Excess, Eyelid Spasm
Being tested: Botulinum toxin
Medical subject headings: Lacerations, Blepharospasm

What participants receive

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

Botulinum toxinDrug
Also called BOTOX
15 units of botulinum toxin administered one time to the eye via eye drops

Study groups in NCT06080438
Study group	Role	What they receive
Botulinum toxin group	Experimental	The left eye of each participant will receive botulinum toxin eye drops and will remain in this group for up to 40 minutes. Receives: Drug: Botulinum toxin

What is being measured

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

Change in Palpebral Fissure Height
Palpebral fissure on Day 3 minus palpebral fissure at baseline.
Palpebral fissure is the area between the upper and lower eyelid margins. Palpebral fissure height on eyes is measured in primary gaze position with a clear ruler held in a central vertical position between the upper and lower eyelid margin.
Measured: baseline and Day 3

Secondary outcomes (3)

Corneal Staining Density
Scoring of the ocular surface will be done by fluorescein staining and evaluating with a slit lamp and grading scale: 0-3 0 (no punctate staining)
1. (sparse density)
2. (moderate density)
3. (high density and overlapping lesions).
Measured: Baseline
Corneal Staining Density
Scoring of the ocular surface will be done by fluorescein staining and evaluating with a slit lamp and grading scale: 0-3 0 (no punctate staining)
1. (sparse density)
2. (moderate density)
3. (high density and overlapping lesions).
Measured: Day 3
Change in Tearing
Change in tearing will be calculated as tearing on Day 3 minus tearing at baseline.
Tearing will be assessed using the Schirmer test with anesthesia. Schirmer strip is inserted into the lower conjunctival sac at the junction of the lateral and middle thirds, avoiding touching the cornea, and the length of wetting strips in millimeters is recorded after 5 minutes.
The result can range from a minimum of 0 mm (no tearing) to a maximum of 35 mm (maximum tearing).
Measured: baseline and Day 3

Timeline

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

29 Nov 202228 Jul 2024

First posted12 Oct 2023
Study start29 Nov 2022
Primary completion28 Jul 2024
Study completion28 Jul 2024

Why it stopped: Patient recruitment shortage and study coordinator turnover

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Tears; ExcessStudies of the same condition, open and under way.
More trials run by University of MiamiThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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 4
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 2 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06080438
Sponsor's protocol ID: 20220083
Status last verified: Nov 2024
First submitted: 5 Oct 2023
Last updated: 5 Dec 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 2
Low-Dose Atropine Eye Drops for Excessive Tearing (Epiphora)
Epiphora
Not yet recruiting
Outcomes of Stentless Dacryocystorhinostomy in Primary Acquired Nasolacrimal Duct Obstruction.
Nasolacrimal Duct Obstruction, Epiphora
Active, not recruitingPhase 4
A Comparative Analysis of the Effectiveness of Nepafenac Combined With a Lubricant Versus a Lubricant Alone in the Treatment of Epiphora Associated With Lacrimal Punctum Stenosis
Epiphora, Punctal Stenosis
RecruitingObservational study
The Effect of Upper Blepharoplasty on Vision Quality in the Early Postoperative Period
Excess Skin of Both Eyelids, Contrast Sensitivity
RecruitingPhase 4
Does Topical Ophthalmic Proparacaine 0.5% Prior to Probing and Irrigation Decrease Pain?
Epiphora, Dacryostenosis

All Tears; Excess trials

Study at a glance

From the registry record, last updated by the sponsor on 5 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Effect of Topical Botulinum Toxin Eyedrop on Palpebral Fissure Height, Ocular Surface and Tearing
ClinicalTrials.gov ID: NCT06080438
Acronym / sponsor ID: 20220083
Conditions: Tears; Excess, Eyelid Spasm
Phase: Phase 4
Study type: Interventional
Recruitment status: TerminatedReason stopped: Patient recruitment shortage and study coordinator turnover
Enrolment: 2 participants (actual)
Lead sponsor: University of MiamiUniversity, hospital or other
Study start: 29 Nov 2022 (actual)
Primary completion: 28 Jul 2024 (actual)
Study completion: 28 Jul 2024 (actual)
First posted: 12 Oct 2023 (actual)
Results: Posted 5 Dec 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Botulinum toxin group	Experimental	Drug: Botulinum toxinThe left eye of each participant will receive botulinum toxin eye drops and will remain in this group for up to 40 minutes.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Adults aged 18 and above that present to the oculoplastic and reconstructive surgery department that are able to provide informed consent to participate
Presence of upper eyelid retraction or asymmetry( >1mm)

Key exclusion criteria (16 listed)

Adults unable to consent
Individuals less than 18 years of age
Prisoners
Pregnant women. o Patients will be asked if they are pregnant by research staff before participation in the study.
Women who are breast-feeding

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Botulinum toxinAlso: BOTOX15 units of botulinum toxin administered one time to the eye via eye drops	Drug	Botulinum toxin group

Primary outcome

Change in Palpebral Fissure Height
Time frame: baseline and Day 3
Palpebral fissure on Day 3 minus palpebral fissure at baseline. Palpebral fissure is the area between the upper and lower eyelid margins. Palpebral fissure height on eyes is measured in primary gaze position with a clear ruler held in a central vertical position between the upper and lower eyelid margin.

3 secondary outcomes

Corneal Staining Density
Time frame: Baseline
Corneal Staining Density
Time frame: Day 3
Change in Tearing
Time frame: baseline and Day 3

Results and safety

Results posted to the registry on 5 Dec 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Botulinum Toxin Group	2	0

Primary outcome: Change in Palpebral Fissure Height

Time frame: baseline and Day 3. Mean (Standard Deviation). Unit: mm

Measure	Botulinum Toxin Group n = 2
Value	-0.5 (0.69)

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: 6 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Botulinum Toxin Group	0 of 2 (0%)	0 of 2 (0%)	0 of 2

Limitations and caveats (from the sponsor): For interim analysis of futility, the investigators conducted the study with BT eye drops on the first 10 patients and then evaluated the results to see if there were any significant effects. If clinically significant effects are seen, then 34 patients totally (17 in BT vs 17 in saline) are included. The study was terminated and did not continue; therefore, only the first phase of the study was conducted with only one arm (BT eye drops) with results reported for the first phase only.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Tears; Excess

RecruitingPhase 2
Low-Dose Atropine Eye Drops for Excessive Tearing (Epiphora)
Epiphora
Not yet recruiting
Outcomes of Stentless Dacryocystorhinostomy in Primary Acquired Nasolacrimal Duct Obstruction.
Nasolacrimal Duct Obstruction, Epiphora
Active, not recruitingPhase 4
A Comparative Analysis of the Effectiveness of Nepafenac Combined With a Lubricant Versus a Lubricant Alone in the Treatment of Epiphora Associated With Lacrimal Punctum Stenosis
Epiphora, Punctal Stenosis
RecruitingObservational study
The Effect of Upper Blepharoplasty on Vision Quality in the Early Postoperative Period
Excess Skin of Both Eyelids, Contrast Sensitivity
RecruitingPhase 4
Does Topical Ophthalmic Proparacaine 0.5% Prior to Probing and Irrigation Decrease Pain?
Epiphora, Dacryostenosis

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Wendy Lee, MD principal investigator

University of Miami

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Botulinum toxin in people with Tears; Excess and Eyelid Spasm, run by University of Miami at 1 site in United States.

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 2 inclusion and 16 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: stopped early, as of the sponsor's last update on 5 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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

Are results available for this study?

Yes. Results are posted in the registry (first posted 5 Dec 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Change in Palpebral Fissure Height (time frame: baseline and Day 3). 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 NCT06080438.

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 5 Dec 2024.