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Completed

NCT Number: NCT03959176

The Effect of Brimonidine

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.

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Key information

Conditions

Intraocular Pressure

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Wake Forest Baptist Medical Center

Winston-Salem, North Carolina, 27157, United States

About this study

Intraocular pressure (IOP) can fluctuate due to various external factors such as exercise, medications, and eye movements. Although it is considered natural for IOP to fluctuate daily, prolonged increases in IOP can be harmful. Sustained elevated IOP has been linked to optic nerve damage and glaucoma. Mydriatic drops routinely given to dilate pupils in patients in need of an eye exam have been known to increase IOP. In practice, a combination of drugs are used to achieve pupil dilation needed for routine eye exams or in perioperative situations. The use of Tropicamide 1% and Phenylephrine 2.5% are known to be safe and effective options for dilating the pupils when used in conjunction with one another, but these drugs can increase IOP. Drugs such as Brimonidine, a selective alpha-2 agonist, are known to reduce IOP through several different methods. This study seeks to understand the effects of Brimonidine used along with Tropicamide and Phenylephrine to control IOP.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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)

Treatment and study plan

Brimonidine

Drug

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

Other names: Alphagan, Mirvaso

Tropicamide

Drug

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

Other names: Mydriacyl

Phenylephrine Ophthalmic Product

Drug

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

Primary outcomes

  1. Intraocular Pressure

    Time frame: Baseline (Pre drop administration)

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

  2. Intraocular Pressure

    Time frame: 15 minutes post drop administration

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

  3. Intraocular Pressure

    Time frame: 30 minutes post drop administration

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

  4. Intraocular Pressure

    Time frame: 1 hour post drop administration

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

  5. Intraocular Pressure

    Time frame: 2 hour post drop administration

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

  6. Intraocular Pressure

    Time frame: 4 hour post drop administration

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

Secondary outcomes

  1. Pupil Size

    Time frame: Baseline (Pre drop administration)

    Pupil size measurement

  2. Pupil Size

    Time frame: 15 minutes post drop administration

    Pupil size measurement.

  3. Pupil Size

    Time frame: 30 minutes post drop administration

    Pupil size measurement

  4. Pupil Size

    Time frame: 1 hour post drop administration

    Pupil size measurement.

  5. Pupil Size

    Time frame: 2 hours post drop administration

    Pupil size measurement.

  6. Pupil Size

    Time frame: 4 hours post drop administration

    Pupil size measurement

  7. Pupil Reaction to Light

    Time frame: Baseline (Pre drop administration)

    Pupil reaction to light will be measured as none (0), poor (1) or brisk (2).

  8. Pupil Reaction to Light

    Time frame: 15 minutes post drop administration

    Pupil reaction to light will be measured as none (0), poor (1) or brisk (2).

  9. Pupil Reaction to Light

    Time frame: 30 minutes post drop administration

    Pupil reaction to light will be measured as none (0), poor (1) or brisk (2).

  10. Pupil Reaction to Light

    Time frame: 1 hour post drop administration

    Pupil reaction to light will be measured as none (0), poor (1) or brisk (2).

  11. Pupil Reaction to Light

    Time frame: 2 hours post drop administration

    Pupil reaction to light will be measured as none (0), poor (1) or brisk (2).

  12. Pupil Reaction to Light

    Time frame: 4 hours post drop administration

    Pupil reaction to light will be measured as none (0), poor (1) or brisk (2).

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Registry information

Official study title

The Effect of Brimonidine on Intraocular Pressure When Dilating Routine Patients, Pressure Control and Pupil Effects

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
May 22, 2019
Registry last updated
Feb 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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