Official Title: “Comparison of the Alpha-2 Agonists for Prevention of Intraocular Pressure Elevation After Selective Laser Trabeculoplasty”

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.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver), Parallel Assignment, Safety/Efficacy Study

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.

Intervention(s) in this Clinical Trial

• Drug: brimonidine 0.1%
  • 1 drop, 1 hour prior to selective laser trabeculoplasty (SLT)
• Drug: Apraclonidine 0.5%
  • 1 drop applied 1 hour prior to SLT

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: I
  • Eyes receiving Apraclonidine 0.5% (Iopidine) prior to SLT
• Active Comparator: A
  • Eyes receiving Brimonidine 0.1% (Alphagan) prior to SLT

Primary Measures

• Postoperative IOP
  • Time Frame: 1 hour and 1 week post surgery
    Safety Issue?: Yes

Secondary Measures

• Overall IOP reduction post SLT
  • Time Frame: 1 month
    Safety Issue?: No

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Walter Reed Army Medical Center

Overall Clinical Trial Officials and Contacts

Vladimir S Yakopson, MD Principal Investigator Walter Reed AMC  

Overall Contact: Vladimir S Yakopson, MD 202-782-6965 vladimir.yakopson@na.amedd.army.mil

Information obtained from ClinicalTrials.gov on October 10, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00567411

Study ID Number: WRAMC WU # 06-23016

ClinicalTrials.gov Identifier: NCT00567411

Health Authority: United States: Federal Government