The Effect of Brimonidine on Intraocular Pressure When Dilating Routine Patients

Phase 1

Completed

• Conditions: Intraocular Pressure
• Interventions: Drug: Alphagan; Drug: Phenylephrine; Drug: Tropicamide

• Registration Number: NCT03139708
• Lead Sponsor: Wake Forest University Health Sciences

Brief Summary

This an interventional study looking at two different sequences of pre-operative eye drops, to determine which order is more effective in reducing intraocular pressure with pupil dilation.

Detailed Description

Twenty healthy participants will be separated into two groups of 10 volunteers each. In both groups, the participant's right eye will serve as a control with only Tropicamide/phenylephrine given. In one group of 10 participants the left eyes will receive Alphagan prior to Tropicamide/phenylephrine. In the other group of 10 eyes, the left eyes will have Tropicamide/phenylephrine administered prior to Alphagan. The investigator will observe the intraocular benefits of the addition of Alphagan over the Tropicamide/phenylephrine alone and determine if pre-treating is any better than post-treating. In addition, the investigator will monitor pupil response, as it is known that Alphagan may have some effect on the pupil dilation.

Study Timeline

• Study Start: 2016-09
• Study First Submitted: 2016-10-05
• Study First Submitted QC: 2017-05-01
• Study First Posted: 2017-05-04
• Primary Completion: 2017-10
• Study Completion: 2017-10
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-07
• Last Update Posted: 2018-08-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 5

Inclusion Criteria

• Healthy with no major medical conditions. Contact lens wear is ok but must be not worn on the day of the study

Exclusion Criteria

• Diabetic, history of glaucoma
• history of iris trauma
• history of eye surgery except LASIK or Photorefractive keratectomy laser eye surgery
• Anisocoria
• pregnancy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Alphagan plus	Alphagan	Alphagan plus group is one drop Brimonidine then, Tropicamide and Phenylephrine ophthalmic one drop,times one.
Alphagan plus	Phenylephrine	Alphagan plus group is one drop Brimonidine then, Tropicamide and Phenylephrine ophthalmic one drop,times one.
Alphagan plus	Tropicamide	Alphagan plus group is one drop Brimonidine then, Tropicamide and Phenylephrine ophthalmic one drop,times one.
Tropicamide and Phenylephrine plus	Phenylephrine	Tropicamide and Phenylephrine plus intervention is one drop of each then Brimonidine one drop, times one.
Tropicamide and Phenylephrine plus	Alphagan	Tropicamide and Phenylephrine plus intervention is one drop of each then Brimonidine one drop, times one.
Tropicamide and Phenylephrine plus	Tropicamide	Tropicamide and Phenylephrine plus intervention is one drop of each then Brimonidine one drop, times one.
Tropicamide and Phenylephrine only	Phenylephrine	Tropicamide and Phenylephrine only arm is given one drop of each times one.
Tropicamide and Phenylephrine only	Tropicamide	Tropicamide and Phenylephrine only arm is given one drop of each times one.

Primary Outcome Measures

Name	Time	Method
Change in intraocular pressure from baseline to 15 min after last drop given, 30 min, 1 hour, and 4 hours.	5 time points all occuring during one time visit: Baseline (pre drops), 15 min after last drop given, 30 min, 1 hour, and 4 hours.	Baseline (pre drops), 15 min after last drop given, 30 min, 1 hour, and 4 hours.

Secondary Outcome Measures

Name	Time	Method
Change in pupil size pupil size from baseline to 15 min after last drop given, 30 min, 1 hour, and 4 hours.	5 time points all occuring during one time visit: Baseline (pre drops), 15 min after last drop given, 30 min, 1 hour, and 4 hours.	Baseline (pre drop), 15 min after last drop given, 30 min, 1 hour, and 4 hours. The investigator will measure the pupils under bright light conditions (photopic) and dim light conditions (scotopic)
Change in pupil's reaction to light from baseline to 15 min after last drop given,30 min, 1 hour, and 4 hours.	5 time points all occuring during one time visit: Baseline (pre drops), 15 min after last drop given, 30 min, 1 hour, and 4 hours.	Baseline (pre drop), 15 min after last drop given, 30 min, 1 hour, and 4 hours. Pupil reaction will be measure either as none, poor, or brisk.

Trial Locations

Locations (1)

Wake Forest Baptist Health Eye Center; 🇺🇸 Winston-Salem, North Carolina, United States