Recruiting

Eye Drops

Sponsor:

Walter Reed Army Medical Center

Code:

NCT00567411

Conditions

Glaucoma

Ocular Hypertension

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

brimonidine 0.1%

Apraclonidine 0.5%

Study Details

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.

Conditions

Glaucoma

Ocular Hypertension

Study ID

NCT00567411

Start date

Aug, 2006

Status verified date

Nov, 2007

Completion date

Jun, 2009

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

43 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: I

Eyes receiving Apraclonidine 0.5% (Iopidine) prior to SLT

active comparator: A

Eyes receiving Brimonidine 0.1% (Alphagan) prior to SLT

Interventions

brimonidine 0.1%

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

Apraclonidine 0.5%

1 drop applied 1 hour prior to SLT

Primary outcome measure

  • Postoperative IOP [ Time Frame: 1 hour and 1 week post surgery ]

Central Contacts and Locations

Central contacts

Vladimir S Yakopson, MD

202-782-6965vladimir.yakopson@na.amedd.army.mil

Locations

Walter Reed Army Medical Center

Recruiting

Washington, District of Columbia, United States, 20307

Contacts

Vladimir S Yakopson, MD

202-782-6965vladimir.yakopson@na.amedd.army.mil

More Information

Sponsor

Walter Reed Army Medical Center

Last update posted

Dec 5, 2007

Last verified

Nov, 2007

Keywords

  • Glaucoma
  • Laser
  • laser trabeculoplasty
  • selective laser trabeculoplasty
  • intraocular pressure

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Walter Reed Army Medical Center on 2007-12-05.