Brimonidine for Intraoperative Hemostasis

NCT05480098 | Withdrawn Phase 4 FDA Drug

• 1 other identifier: 21.0989
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to observe and report the effects of topical ophthalmic brimonidine in oculofacial plastic surgery.

Conditions

Dermatochalasis of Eyelid; Ptosis, Eyelid; Ectropion; Entropion

Outcome Measures

Primary Outcomes (1)

• Hemostasis

  Change in Hemostasis Score

  At the time of surgery.

Study Arms (2)

Brimonidine intervention

EXPERIMENTAL

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).

Drug: Brimonidine Topical

Control Arm

NO 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).

Interventions

Brimonidine Topical DRUG

Topical brimonidine intraoperatively for hemostasis

Also known as: Alphagan

Brimonidine intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Above the age of 18
• Ophthalmic conditions requiring oculoplastic surgery

You may not qualify if:

• Known allergy or adverse effects to brimonidine
• Hypotony
• Acute ophthalmic infection
• History of hypotension
• Orthostatic hypotension
• Pregnancy
• History of Central Nervous System (CNS) depression from medication use
• Thrombotic disorders
• Asymmetrical oculoplastic conditions that may interfere with tear drainage (e.g. unilateral NLDO)
• Current use of brimonidine

Sponsors & Collaborators

• University of Louisville: lead

Study Sites (1)

University of Louisville

Louisville, Kentucky, 40202, United States

Location

Related Publications (5)

• Hong S, Kim CY, Seong GJ, Han SH. Effect of prophylactic brimonidine instillation on bleeding during strabismus surgery in adults. Am J Ophthalmol. 2007 Sep;144(3):469-70. doi: 10.1016/j.ajo.2007.04.038.

  PMID: 17765438 BACKGROUND

• Ucar F, Cetinkaya S. The Results of Preoperative Topical Brimonidine Usage in Pterygium Surgery. J Ocul Pharmacol Ther. 2020 May;36(4):234-237. doi: 10.1089/jop.2019.0085. Epub 2020 Feb 27.

  PMID: 32105500 BACKGROUND

• Kim DH, Yang HK, Han SB, Hwang JM. Effect of Topical Brimonidine 0.15% on Conjunctival Injection after Strabismus Surgery in Children. J Ophthalmol. 2021 May 4;2021:5574194. doi: 10.1155/2021/5574194. eCollection 2021.

  PMID: 34055396 BACKGROUND

• Kim CS, Nam KY, Kim JY. Effect of prophylactic topical brimonidine (0.15%) administration on the development of subconjunctival hemorrhage after intravitreal injection. Retina. 2011 Feb;31(2):389-92. doi: 10.1097/IAE.0b013e3181eef28e.

  PMID: 20890238 BACKGROUND

• Ucar F, Cetinkaya S. The Results of Preoperative Use of Topical Brimonidine in Strabismus Surgery. J Ocul Pharmacol Ther. 2021 May;37(4):230-235. doi: 10.1089/jop.2020.0144. Epub 2021 Mar 8.

  PMID: 33684337 BACKGROUND

MeSH Terms

Conditions

Blepharoptosis; Ectropion; Entropion

Interventions

Brimonidine Tartrate

Condition Hierarchy (Ancestors)

Eyelid Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Quinoxalines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Christopher Compton, MD

  University of Louisville

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: This study will be blinded to the surgeon grading the severity of bleeding and the patient will be unaware which side would receive the intervention.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: A randomized, prospective clinical trial will be performed with IRB approval to compare intraoperative application of ophthalmic brimonidine solution to standard methods of hemostasis control. This study will be blinded to the surgeon grading the severity of bleeding and the patient unaware which side would receive the intervention. Topical brimonidine ophthalmic solution will be placed intraoperatively to the open surgical wound of one eyelid and we will assess the severity of bleeding via a surgeon's grading scale. The fellow eye's surgical wound will be used as the control. The laterality of intervention is randomized. Reduction of bleeding severity is the primary outcome as graded by a subjective surgeon's grading scale. A secondary outcome may be severity of postoperative bruising in the study eye versus the fellow control eye, as graded by post-operative bruising severity.

Study Record Dates

• First Submitted: June 6, 2022
• First Posted: July 29, 2022
• Study Start: May 26, 2022
• Primary Completion: May 22, 2024
• Study Completion: May 22, 2024
• Last Updated: January 15, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)