NCT00413751

Brief Summary

The objective of this study is to evaluate the effect of brimonidine tartrate ophthalmic solution 0.15% (Alphagan P) on pupil diameter under different luminance conditions.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

December 19, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 20, 2006

Completed
Last Updated

December 20, 2006

Status Verified

December 1, 2006

First QC Date

December 19, 2006

Last Update Submit

December 19, 2006

Conditions

Healthy

Keywords

Large pupils rendering night vision difficulties such as haloes, glare, and monocular diplopia

Interventions

Brimonidine tartrate ophthalmic solution 0.15% (Alphagan P)DRUG

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Adult active duty personnel between 18 and 50 years of age with best corrected visual acuity of 20/20 or better.

You may not qualify if:

  • Patients not meeting above stated age criteria
  • Females that are pregnant or lactating (non pregnant females of childbearing potential will have pregnancy test prior to participating in study)
  • History of serious ocular, neurological, cardiovascular disease
  • History of severe systemic disease
  • History of arrhythmias or high blood pressure
  • Patients currently taking any type of ocular or systemic medications except multivitamins.
  • Patients with abnormal pupil shape, Addie's pupil, anisocoria, or abnormal pupil defect.

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

Location

MeSH Terms

Conditions

Diplopia

Interventions

Brimonidine Tartrate

Condition Hierarchy (Ancestors)

Vision DisordersSensation DisordersNeurologic ManifestationsNervous System DiseasesEye DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

QuinoxalinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • KRAIG S. BOWER, MD

    Walter Reed Army Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
FED

Study Record Dates

First Submitted

December 19, 2006

First Posted

December 20, 2006

Last Updated

December 20, 2006

Record last verified: 2006-12

Locations

US(1)