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

Glaucoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00567411
• Other study ID #: WRAMC WU # 06-23016
• Status: Recruiting
• Phase: N/A
• First received: December 4, 2007
• Last updated: December 4, 2007
• Start date: August 2006
• Est. completion date: June 2009

Study information

• Verified date: November 2007
• Source: Walter Reed Army Medical Center
• Contact: Vladimir S Yakopson, MD
• Phone: 202-782-6965
• Email: vladimir.yakopson[@]na.amedd.army.mil
• Is FDA regulated: No
• Health authority: United States: Federal GovernmentUnited States: Human Use Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 43
• Est. completion date: June 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Glaucoma
• Ocular Hypertension

Intervention

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

Locations

Country	Name	City	State
United States	Walter Reed Army Medical Center	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Walter Reed Army Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative IOP		1 hour and 1 week post surgery	Yes
Secondary	Overall IOP reduction post SLT		1 month	No