Phase 4
N=13
The Effect of Brimonidine
Intraocular Pressure
Bottom Line
View on ClinicalTrials.gov: NCT03959176 ↗Enrolled (actual)
13
Serious AEs
0.0%
Results posted
Feb 2024
Primary outcome: Primary: Intraocular Pressure — 15.4; 16.3; 16.5; 16.7 millimeters of mercury (mmHg)
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Brimonidine (Drug); Tropicamide (Drug); Phenylephrine Ophthalmic Product (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Wake Forest University Health Sciences
- Primary completion
- Jul 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Intraocular Pressure |
12.4; 9.3; 11.0; 13.7 | — |
| PRIMARY Intraocular Pressure |
12.4; 9.3; 11.0; 13.7 | — |
| PRIMARY Intraocular Pressure |
12.4; 9.3; 11.0; 13.7 | — |
| PRIMARY Intraocular Pressure |
12.4; 9.3; 11.0; 13.7 | — |
| PRIMARY Intraocular Pressure |
12.4; 9.3; 11.0; 13.7 | — |
| PRIMARY Intraocular Pressure |
12.4; 9.3; 11.0; 13.7 | — |
| SECONDARY Pupil Size |
7.6; 7.6; 6.7; 7.6 | — |
| SECONDARY Pupil Size |
7.6; 7.6; 6.7; 7.6 | — |
| SECONDARY Pupil Size |
7.6; 7.6; 6.7; 7.6 | — |
| SECONDARY Pupil Size |
7.6; 7.6; 6.7; 7.6 | — |
| SECONDARY Pupil Size |
7.6; 7.6; 6.7; 7.6 | — |
| SECONDARY Pupil Size |
7.6; 7.6; 6.7; 7.6 | — |
| SECONDARY Pupil Reaction to Light |
1; 1 | — |
| SECONDARY Pupil Reaction to Light |
1; 1 | — |
| SECONDARY Pupil Reaction to Light |
1; 1 | — |
| SECONDARY Pupil Reaction to Light |
1; 1 | — |
| SECONDARY Pupil Reaction to Light |
1; 1 | — |
| SECONDARY Pupil Reaction to Light |
1; 1 | — |
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.
Eligibility Criteria
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)
Data sourced from ClinicalTrials.gov (NCT03959176). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.