The Effect of Brimonidine on Intraocular Pressure When Dilating Routine Patients

Study Overview
=================
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.

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

Conditions
-----------------
Intraocular Pressure

Intervention / Treatment
-----------------
* Drug: Alphagan
* Drug: Phenylephrine
* Drug: Tropicamide


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Alphagan plus<br>Alphagan plus group is one drop Brimonidine then, Tropicamide and Phenylephrine ophthalmic one drop,times one. | Drug: Alphagan<br>* Arm: Experimental: Alphagan plus Alphagan plus group is one drop Brimonidine then, Tropicamide and Phenylephrine ophthalmic one drop,times one. Arm: Experimental: Tropicamide and Phenylephrine plus Tropicamide and Phenylephrine plus intervention is one drop of each then Brimonidine one drop, times one.<br>* Other names: Brimonidine;Drug: Phenylephrine<br>* Arm: Experimental: Alphagan plus Alphagan plus group is one drop Brimonidine then, Tropicamide and Phenylephrine ophthalmic one drop,times one. Arm: Experimental: Tropicamide and Phenylephrine plus Tropicamide and Phenylephrine plus intervention is one drop of each then Brimonidine one drop, times one. Arm: Active Comparator: Tropicamide and Phenylephrine only Tropicamide and Phenylephrine only arm is given one drop of each times one.<br>Drug: Tropicamide<br>* Arm: Experimental: Alphagan plus Alphagan plus group is one drop Brimonidine then, Tropicamide and Phenylephrine ophthalmic one drop,times one. Arm: Experimental: Tropicamide and Phenylephrine plus Tropicamide and Phenylephrine plus intervention is one drop of each then Brimonidine one drop, times one. Arm: Active Comparator: Tropicamide and Phenylephrine only Tropicamide and Phenylephrine only arm is given one drop of each times one.<br>|
| Experimental: Tropicamide and Phenylephrine plus<br>Tropicamide and Phenylephrine plus intervention is one drop of each then Brimonidine one drop, times one. | Drug: Alphagan<br>* Arm: Experimental: Alphagan plus Alphagan plus group is one drop Brimonidine then, Tropicamide and Phenylephrine ophthalmic one drop,times one. Arm: Experimental: Tropicamide and Phenylephrine plus Tropicamide and Phenylephrine plus intervention is one drop of each then Brimonidine one drop, times one.<br>* Other names: Brimonidine;Drug: Phenylephrine<br>* Arm: Experimental: Alphagan plus Alphagan plus group is one drop Brimonidine then, Tropicamide and Phenylephrine ophthalmic one drop,times one. Arm: Experimental: Tropicamide and Phenylephrine plus Tropicamide and Phenylephrine plus intervention is one drop of each then Brimonidine one drop, times one. Arm: Active Comparator: Tropicamide and Phenylephrine only Tropicamide and Phenylephrine only arm is given one drop of each times one.<br>Drug: Tropicamide<br>* Arm: Experimental: Alphagan plus Alphagan plus group is one drop Brimonidine then, Tropicamide and Phenylephrine ophthalmic one drop,times one. Arm: Experimental: Tropicamide and Phenylephrine plus Tropicamide and Phenylephrine plus intervention is one drop of each then Brimonidine one drop, times one. Arm: Active Comparator: Tropicamide and Phenylephrine only Tropicamide and Phenylephrine only arm is given one drop of each times one.<br>|
| Active Comparator: Tropicamide and Phenylephrine only<br>Tropicamide and Phenylephrine only arm is given one drop of each times one. | Drug: Phenylephrine<br>* Arm: Experimental: Alphagan plus Alphagan plus group is one drop Brimonidine then, Tropicamide and Phenylephrine ophthalmic one drop,times one. Arm: Experimental: Tropicamide and Phenylephrine plus Tropicamide and Phenylephrine plus intervention is one drop of each then Brimonidine one drop, times one. Arm: Active Comparator: Tropicamide and Phenylephrine only Tropicamide and Phenylephrine only arm is given one drop of each times one.<br>Drug: Tropicamide<br>* Arm: Experimental: Alphagan plus Alphagan plus group is one drop Brimonidine then, Tropicamide and Phenylephrine ophthalmic one drop,times one. Arm: Experimental: Tropicamide and Phenylephrine plus Tropicamide and Phenylephrine plus intervention is one drop of each then Brimonidine one drop, times one. Arm: Active Comparator: Tropicamide and Phenylephrine only Tropicamide and Phenylephrine only arm is given one drop of each times one.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in intraocular pressure from baseline to 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. | 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. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in pupil size pupil size from baseline to 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) | 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. | 
| Change in pupil's reaction to light from baseline to 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. | 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. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Mydriasis, Cycloplegics