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Brimonidine for Oculofacial Surgery
Phase 4
Recruiting
Led By Christopher Compton, MD
Research Sponsored by University of Louisville
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Ophthalmic conditions requiring oculoplastic surgery
Above the age of 18
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at the time of surgery.
Awards & highlights
Study Summary
This trial will observe the effects of a topical medication called brimonidine in patients undergoing oculofacial plastic surgery.
Who is the study for?
This trial is for adults over 18 needing oculoplastic surgery due to conditions like droopy eyelids. It's not suitable for those with eye infections, a history of CNS depression from meds, clotting issues, current brimonidine use, certain asymmetrical eye conditions, very low eye pressure (hypotony), known brimonidine allergy or side effects, a history of low blood pressure (hypotension), orthostatic hypotension, or if pregnant.Check my eligibility
What is being tested?
The study is testing the effectiveness of a topical medication called Brimonidine in controlling bleeding during facial surgeries involving the eyes. The goal is to see how well it works when applied directly to the surgical area.See study design
What are the potential side effects?
Brimonidine may cause dry mouth and eyes, fatigue, headache, dizziness; rarely can lead to lowered heart rate or blood pressure. Side effects are generally mild but vary between individuals.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I need eye surgery due to a condition.
Select...
I am older than 18 years.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at the time of surgery.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at the time of surgery.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Hemostatic function
Side effects data
From 2013 Phase 4 trial • 376 Patients • NCT020035346%
Conjunctiva Hyperemia
100%
80%
60%
40%
20%
0%
Study treatment Arm
0.15% Brimonidine Tartrate
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Brimonidine interventionExperimental Treatment1 Intervention
We will compare hemostasis between 2 surgical sides of the same patient. One side will be randomized to receive Brimonidine (0.15% or 0.2%) in addition to standard hemostasis measures, while the other side will receive only standard hemostasis measures (preoperative discontinuation of blood thinners, preoperative injection of lidocaine with epinephrine).
Group II: Control ArmActive Control1 Intervention
We will compare hemostasis between 2 surgical sides of the same patient. One side will be randomized to receive Brimonidine (0.15% or 0.2%) in addition to standard hemostasis measures, while the other side will receive only standard hemostasis measures (preoperative discontinuation of blood thinners, preoperative injection of lidocaine with epinephrine).
Find a Location
Who is running the clinical trial?
University of LouisvilleLead Sponsor
339 Previous Clinical Trials
76,580 Total Patients Enrolled
Christopher Compton, MDPrincipal InvestigatorUniversity of Louisville
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have experienced brain fog or drowsiness from medication.I experience significant drops in blood pressure when standing up.I am older than 18 years.You have had bad reactions to brimonidine in the past.I have a history of low blood pressure.I have low eye pressure.I need eye surgery due to a condition.I currently have an eye infection.I have a blood clotting disorder.I am currently using brimonidine.I have an eye condition affecting tear drainage.
Research Study Groups:
This trial has the following groups:- Group 1: Control Arm
- Group 2: Brimonidine intervention
Awards:
This trial has 3 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are applications being accepted for this clinical research endeavor?
"Affirmative. According to the clinicaltrials.gov website, this clinical trial is currently looking for participants. It was initially posted on May 26th 2022 and updated lastly on July 27th 2022; 100 patients need to be enrolled from one medical site."
Answered by AI
Has Brimonidine Topical been granted any regulatory clearances?
"Brimonidine Topical has been approved, so its safety rating is a 3 out of 3."
Answered by AI
How many participants are currently undergoing treatment in this trial?
"Affirmative. Data from clinicaltrials.gov reveals that this experimental study, which was initially published on May 26th 2022, is still actively recruiting for participants. Approximately 100 human subjects need to be enrolled at 1 research centre."
Answered by AI
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