The Effect of Brimonidine on Intraocular Pressure When Dilating Routine Patients

Wake Forest University (WFU)

Status and phase: Completed; Phase 1

Conditions: Intraocular Pressure

Treatments: Drug: Tropicamide; Drug: Phenylephrine; Drug: Alphagan

Study type: Interventional

Funder types: Other

Identifiers

NCT03139708

IRB00039213

Details and patient eligibility

About

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.

Full 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.

Enrollment: 5 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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5 participants in 3 patient groups

Alphagan plus

Experimental group

Description:

Alphagan plus group is one drop Brimonidine then, Tropicamide and Phenylephrine ophthalmic one drop,times one.

Treatment:

Drug: Alphagan

Drug: Phenylephrine

Drug: Tropicamide

Tropicamide and Phenylephrine plus

Experimental group

Description:

Tropicamide and Phenylephrine plus intervention is one drop of each then Brimonidine one drop, times one.

Treatment:

Drug: Alphagan

Drug: Phenylephrine

Drug: Tropicamide

Tropicamide and Phenylephrine only

Active Comparator group

Description:

Tropicamide and Phenylephrine only arm is given one drop of each times one.

Treatment:

Drug: Phenylephrine

Drug: Tropicamide