EpiphoraPhase 2NCT03266081

Bupivacaine Epiphora Trial

A Phase 2 study testing 0.75% bupivacaine in people with Epiphora and Ptosis, run by McMaster University at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record

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Trial summary

The objective of this study is to investigate quantitative improvement in excessive tearing after administration of Bupivacaine, a local anesthetic, into the affected eyelids. Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Epiphora, Ptosis
What is being tested?: 0.75% bupivacaine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 0 participants
Where: 1 siteUnited States
Study dates: Apr 2015to 23 Aug 2022
Phase: Phase 2
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
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Patients age 18 and above, patients with unilateral or bilateral excessive tearing.

Who cannot join

Pregnant females, vulnerable populations, patients with severe hepatic disease, or patients using monoamine oxidase inhibitors or tricyclic antidepressants, which are contraindicated with bupivacaine and norepinephrine combinations.

Trial locations and contacts

1 site in 1 country.

United States1 site

Icahn School of Medicine at Mount Sinai
New York, New York, 10029

Other trials in United States

About this study

Official title: Improving Epiphora & Ptosis With Bupivacaine

The objective of this study is to investigate quantitative improvement in excessive tearing after administration of Bupivacaine, a local anesthetic, into the affected eyelids.

Conditions: Epiphora, Ptosis
Being tested: 0.75% bupivacaine
Medical subject headings: Lacrimal Apparatus Diseases, Blepharoptosis

What participants receive

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

0.75% bupivacaineDrug
topical anesthetic

Study groups in NCT03266081
Study group	Role	What they receive
0.75% bupivacaine	Experimental	Not described Receives: Drug: 0.75% bupivacaine

What is being measured

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

Change from Baseline Lacrimal Tear Lake at 6 months
Measurement of the height (in mm) of the tear film in the lower conjunctival cup de sac, obtained during slit lamp examination of the eye
Measured: measurements at baseline and 6 months

Secondary outcomes (2)

Change from baseline Lid distraction at 6 months
distance (in mm) that the eyelids can be maximally pulled from the globe
Measured: measurements at baseline and 6 months
Change from baseline Lid snap back at 6 months
Amount of time (in sec) it takes for the lids to return to their normal anatomical position after being pulled to their maximum excursion with fingers
Measured: measurements at baseline and 6 months

Timeline

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

Apr 201523 Aug 2022

First posted29 Aug 2017
Study startApr 2015
Primary completion23 Aug 2022
Study completion23 Aug 2022

Why it stopped: No patients

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for EpiphoraStudies of the same condition, open and under way.
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 2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 0 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03266081
Sponsor's protocol ID: HS#: 14-00614
Status last verified: Aug 2022
First submitted: 22 Aug 2017
Last updated: 25 Aug 2022
Results posted: 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
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Outcomes of Stentless Dacryocystorhinostomy in Primary Acquired Nasolacrimal Duct Obstruction.
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Comparison of the Flexibility of the Perineum in Primiparous Women Using the Medical Device Emagina During 90 Days of Their Pregnancy Compared to Those Having a Standard Pregnancy Follow-up
Pregnancy, Childbirth
Enrolling by invitationPhase 1
Pain Biomarker Study
Migraine, Cluster Headache
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

All Epiphora trials

Study at a glance

From the registry record, last updated by the sponsor on 25 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Improving Epiphora & Ptosis With Bupivacaine
ClinicalTrials.gov ID: NCT03266081
Acronym / sponsor ID: HS#: 14-00614
Conditions: Epiphora, Ptosis
Phase: Phase 2
Study type: Interventional
Recruitment status: WithdrawnReason stopped: No patients
Enrolment: 0 participants (actual)
Lead sponsor: McMaster UniversityUniversity, hospital or other
Study start: Apr 2015 (actual)
Primary completion: 23 Aug 2022 (actual)
Study completion: 23 Aug 2022 (actual)
First posted: 29 Aug 2017 (actual)
Results: Not posted in the source record

Clinical summary

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

The objective of this study is to investigate quantitative improvement in excessive tearing after administration of Bupivacaine, a local anesthetic, into the affected eyelids.

Study design

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

Arm	Type	Receives
0.75% bupivacaine	Experimental	Drug: 0.75% bupivacaine

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

Patients age 18 and above, patients with unilateral or bilateral excessive tearing.

Key exclusion criteria (1 listed)

Pregnant females, vulnerable populations, patients with severe hepatic disease, or patients using monoamine oxidase inhibitors or tricyclic antidepressants, which are contraindicated with bupivacaine and norepinephrine combinations.

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
0.75% bupivacainetopical anesthetic	Drug	0.75% bupivacaine

Primary outcome

Change from Baseline Lacrimal Tear Lake at 6 months
Time frame: measurements at baseline and 6 months
Measurement of the height (in mm) of the tear film in the lower conjunctival cup de sac, obtained during slit lamp examination of the eye

2 secondary outcomes

Change from baseline Lid distraction at 6 months
Time frame: measurements at baseline and 6 months
Change from baseline Lid snap back at 6 months
Time frame: measurements at baseline and 6 months

Results and safety

The study was withdrawn before enrolling participants, so there are no results.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2022.
Individual participant dataSharing planned: No

Related trials for Epiphora

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 recruiting
Comparison of the Flexibility of the Perineum in Primiparous Women Using the Medical Device Emagina During 90 Days of Their Pregnancy Compared to Those Having a Standard Pregnancy Follow-up
Pregnancy, Childbirth
Enrolling by invitationPhase 1
Pain Biomarker Study
Migraine, Cluster Headache
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

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.

Albert Y Wu, MD PhD principal investigator

Icahn School of Medicine at Mount Sinai

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

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing 0.75% bupivacaine in people with Epiphora and Ptosis, run by McMaster University 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 1 inclusion and 1 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: withdrawn, as of the sponsor's last update on 25 Aug 2022. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 was withdrawn before enrolling participants, so there are no results.

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 from Baseline Lacrimal Tear Lake at 6 months (time frame: measurements at baseline and 6 months). 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 NCT03266081.

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 25 Aug 2022.