Comparison of the Alpha-2 Agonists for Prevention of Intraocular Pressure Elevation After Selective Laser Trabeculoplasty

Sponsor

Walter Reed Army Medical Center (U.S. Fed)

Overall Status

Unknown status

CT.gov ID

NCT00567411

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

1.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of the study is to compare the safety and efficacy of two drops used to lower eye pressure when given prior to a glaucoma laser procedure.

Condition or Disease	Intervention/Treatment	Phase
Glaucoma Ocular Hypertension	Drug: brimonidine 0.1% Drug: Apraclonidine 0.5%	N/A

Detailed Description

This is a prospective randomized double blind trial of patients undergoing selective laser trabeculoplasty for primary open angle glaucoma and ocular hypertension. Enrolled patients are randomized to receive one drop of brimonidine 0.1% in one eye and one drop of apraclonidine 0.5% in the fellow eye. The trabecular meshwork in both eyes of each enrolled patient is treated 360 degrees at the same sitting. Intraocular pressure is measured in each eye one hour before applying the study medications and at one hour and one week after laser surgery.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

43 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Care Provider)

Primary Purpose:

Treatment

Official Title:

Comparison of the Alpha-2 Agonists for Prevention of Intraocular Pressure Elevation After Selective Laser Trabeculoplasty

Study Start Date :

Aug 1, 2006

Anticipated Study Completion Date :

Jun 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: I Eyes receiving Apraclonidine 0.5% (Iopidine) prior to SLT	Drug: Apraclonidine 0.5% 1 drop applied 1 hour prior to SLT
Active Comparator: A Eyes receiving Brimonidine 0.1% (Alphagan) prior to SLT	Drug: brimonidine 0.1% 1 drop, 1 hour prior to selective laser trabeculoplasty (SLT)

Arm

Intervention/Treatment

Active Comparator: I

Eyes receiving Apraclonidine 0.5% (Iopidine) prior to SLT

Drug: Apraclonidine 0.5%

1 drop applied 1 hour prior to SLT

Active Comparator: A

Eyes receiving Brimonidine 0.1% (Alphagan) prior to SLT

Drug: brimonidine 0.1%

1 drop, 1 hour prior to selective laser trabeculoplasty (SLT)

Outcome Measures

Primary Outcome Measures

Postoperative IOP [1 hour and 1 week post surgery]

Secondary Outcome Measures

Overall IOP reduction post SLT [1 month]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

male or female, at least 18 years of age
Open Angle Glaucoma with inadequate intraocular pressure (IOP) control or evidence of progression (based on optic nerve head appearance and/or visual field changes) despite current medical therapy
Ocular Hypertension requiring lowering of IOP
ability to understand and provide informed consent to participate in this study and willingness to follow study instructions and likely to complete all required visits

Exclusion Criteria:

inability to understand and provide informed consent to participate in this study
inability/unwillingness to follow study instructions and complete all required visits
Documented allergy to either brimonidine or iopidine
Angle Closure Glaucoma
Congenital/Juvenile Glaucoma
Neovascular Glaucoma
Active uveitis