NCT00567411

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
43

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2006

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2006

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

December 4, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 5, 2007

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2009

Completed
Last Updated

December 5, 2007

Status Verified

November 1, 2007

First QC Date

December 4, 2007

Last Update Submit

December 4, 2007

Conditions

GlaucomaOcular Hypertension

Keywords

GlaucomaLaserlaser trabeculoplastyselective laser trabeculoplastyintraocular pressure

Outcome Measures

Primary Outcomes (1)

  • Postoperative IOP

    1 hour and 1 week post surgery

Secondary Outcomes (1)

  • Overall IOP reduction post SLT

    1 month

Study Arms (2)

I

ACTIVE COMPARATOR

Eyes receiving Apraclonidine 0.5% (Iopidine) prior to SLT

Drug: Apraclonidine 0.5%

A

ACTIVE COMPARATOR

Eyes receiving Brimonidine 0.1% (Alphagan) prior to SLT

Drug: brimonidine 0.1%

Interventions

brimonidine 0.1%DRUG

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

A
Apraclonidine 0.5%DRUG

1 drop applied 1 hour prior to SLT

I

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Walter Reed Army Medical Center

Washington D.C., District of Columbia, 20307, United States

RECRUITING

MeSH Terms

Conditions

GlaucomaOcular Hypertension

Condition Hierarchy (Ancestors)

Eye Diseases

Study Officials

  • Vladimir S Yakopson, MD

    Walter Reed AMC

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Vladimir S Yakopson, MD

CONTACT

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
FED

Study Record Dates

First Submitted

December 4, 2007

First Posted

December 5, 2007

Study Start

August 1, 2006

Study Completion

June 1, 2009

Last Updated

December 5, 2007

Record last verified: 2007-11

Locations

US(1)