A Phase 2 interventional study of 0.75% bupivacaine in Epiphora and Ptosis, sponsored by McMaster University. Withdrawn at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-08-25.
Sponsored by McMaster University · Phase 2, Interventional, and Treatment
The objective of this study is to investigate quantitative improvement in excessive tearing after administration of Bupivacaine, a local anesthetic, into the affected eyelids.
36 studies on the registry are indexed under Lacrimal Apparatus Diseases; 2 are open to participants now.
Browse Lacrimal Apparatus Diseases studies →McMaster University is the lead sponsor of 741 studies on the registry; 127 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 3 (43%) have results posted.
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Patients age 18 and above, patients with unilateral or bilateral excessive tearing.
Exclusion Criteria:
Pregnant females, vulnerable populations, patients with severe hepatic disease, or patients using monoamine oxidase inhibitors or tricyclic antidepressants, which are with bupivacaine and norepinephrine combinations.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: 0.75% bupivacaine
topical anesthetic
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
Time frame: measurements at baseline and 6 months
Change from baseline Lid distraction at 6 months
distance (in mm) that the eyelids can be maximally pulled from the globe
Time frame: 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
Time frame: measurements at baseline and 6 months
Plan to share: No
No publications or documents are linked to this record.
Ran from Apr 2015 to primary completion in Aug 2022, 88 months.
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This study is withdrawn, as verified in Aug 2022. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Bupivacaine