The Effect of Brimonidine

NCT03959176 | Completed Phase 4 Results FDA Drug

• 1 other identifier: IRB00058366
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief Summary

This study will evaluate whether pre-treating patients with Brimonidine 0.2% before and/or after dilating the pupils will help to control the changes in intraocular pressure often seen when using dilating drops. The study will also evaluate the effects of different sequences of administering dilating drops along with Brimonidine on pupil size and reactivity.

Conditions

Intraocular Pressure

Keywords

Brimonidine; Pupil Effects

Outcome Measures

Primary Outcomes (6)

• Intraocular Pressure

  To observe how differing the sequence of administration of Tropicamide 1%/Phenylephrine 2.5% and Brimonidine 0.2% influences intraocular pressure.

  Baseline (Pre drop administration)

• Intraocular Pressure

  To observe how differing the sequence of administration of Tropicamide 1%/Phenylephrine 2.5% and Brimonidine 0.2% influences intraocular pressure.

  15 minutes post drop administration

• Intraocular Pressure

  To observe how differing the sequence of administration of Tropicamide 1%/Phenylephrine 2.5% and Brimonidine 0.2% influences intraocular pressure.

  30 minutes post drop administration

• Intraocular Pressure

  To observe how differing the sequence of administration of Tropicamide 1%/Phenylephrine 2.5% and Brimonidine 0.2% influences intraocular pressure.

  1 hour post drop administration

• Intraocular Pressure

  To observe how differing the sequence of administration of Tropicamide 1%/Phenylephrine 2.5% and Brimonidine 0.2% influences intraocular pressure.

  2 hour post drop administration

• Intraocular Pressure

  To observe how differing the sequence of administration of Tropicamide 1%/Phenylephrine 2.5% and Brimonidine 0.2% influences intraocular pressure.

  4 hour post drop administration

Secondary Outcomes (12)

• Pupil Size

  Baseline (Pre drop administration)

• Pupil Size

  15 minutes post drop administration

• Pupil Size

  30 minutes post drop administration

• Pupil Size

  1 hour post drop administration

• Pupil Size

  2 hours post drop administration

Study Arms (2)

Group 1

EXPERIMENTAL

The right eye will receive a sham drop followed by 1 drop of Tropicamide 1%/Phenylephrine 2.5% five minutes after the sham drop is administered. A one minute wait will occur followed by a second drop of Tropicamide 1%/Phenylephrine 2.5%. The left eye will receive 2 drops of Brimonidine 0.2% followed by a five minute wait time. One drop of Tropicamide 1%/Phenylephrine 2.5% will then be administered followed by a one minute wait time. A second drop of Tropicamide 1%/Phenylephrine 2.5% will be administered.

Drug: Brimonidine; Drug: Tropicamide; Drug: Phenylephrine Ophthalmic Product

Group 2

EXPERIMENTAL

The right eye will receive 1 drop of Tropicamide 1%/Phenylephrine 2.5% followed by a one minute wait. A second drop of Tropicamide 1%/Phenylephrine 2.5% will be administered followed by a 15 second wait after which a sham drop will be administered. The left eye will receive 1 drop of Tropicamide 1%/Phenylephrine 2.5% followed by a one minute wait. A second drop of Tropicamide 1%/Phenylephrine 2.5% will then be administered followed by a 15 second wait after which 2 drops of Brimonidine will be administered.

Drug: Brimonidine; Drug: Tropicamide; Drug: Phenylephrine Ophthalmic Product

Interventions

Brimonidine DRUG

2 drops administered once in the left eye in both study arms

Also known as: Alphagan, Mirvaso

Group 1; Group 2

Tropicamide DRUG

1 drop administered at two different times points in both eyes in both study arms

Also known as: Mydriacyl

Group 1; Group 2

Phenylephrine Ophthalmic Product DRUG

1 drop administered at two different time points in both eyes in both study arms

Group 1; Group 2

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy individuals
• Females of childbearing potential must agree to use a reliable method of birth control while participating in the study.

You may not qualify if:

• Diabetic
• Have a history of glaucoma
• Have a history of iris trauma
• Have a history of eye surgery except for LASIK or PRK
• Pregnant
• Anisocoria (unequal pupils)

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (1)

Wake Forest Baptist Medical Center

Winston-Salem, North Carolina, 27157, United States

Location

MeSH Terms

Interventions

Brimonidine Tartrate; Tropicamide

Intervention Hierarchy (Ancestors)

Quinoxalines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring

Results Point of Contact

• Title: Keith Walter, MD
• Organization: Wake Forest University School of Medicine

kwalter@wakehealth.edu

336-716-2144

Study Officials

• Keith Walter, MD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 20, 2019
• First Posted: May 22, 2019
• Study Start: July 20, 2019
• Primary Completion: July 20, 2019
• Study Completion: July 20, 2019
• Last Updated: February 1, 2024
• Results First Posted: February 1, 2024

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)