NCT01345448

Brief Summary

The purpose of this study is to evaluate the safety and effectiveness in lowering intraocular pressure (IOP) utilizing an experimental lotion containing 0.1% Brimonidine that is applied to the outside of one eyelid.

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
22

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Apr 2011

Shorter than P25 for phase_2

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

April 1, 2011

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

April 27, 2011

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 2, 2011

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2011

Completed
Last Updated

May 2, 2011

Status Verified

April 1, 2011

Enrollment Period

3 months

First QC Date

April 27, 2011

Last Update Submit

April 28, 2011

Conditions

Glaucoma

Keywords

GlaucomaBrimonidineTransdermal

Outcome Measures

Primary Outcomes (18)

  • Intraocular Pressure

    Day one, every hour for twelve hours.

  • Heart Rate

    Day one, every hour for twelve hours.

  • Blood Pressure

    Day one, every hour for twelve hours.

  • Intraocular Pressure

    Day two twice, once in the AM, once in the PM.

  • Intraocular Pressure

    Day seven, once.

  • Intraocular Pressure

    Day fourteen, once.

  • Intraocular Pressure

    Day twenty one, once.

  • Intraocular Pressure

    Day twenty eight, once.

  • Heart Rate

    Day two twice, once in the AM, once in the PM.

  • Heart Rate

    Day seven, once.

  • Heart Rate

    Day fourteen, once.

  • Heart Rate

    Day twenty one, once.

  • Heart Rate

    Day twenty eight, once.

  • Blood Pressure

    Day two twice, once in the AM, once in the PM.

  • Blood Pressure

    Day seven, once.

  • Blood Pressure

    Day fourteen, once.

  • Blood Pressure

    Day twenty one, once.

  • Blood Pressure

    Day twenty eight, once.

Interventions

BrimonidineDRUG

0.1% Brimonidine Lotion, dosed once.

Also known as: Alphagan
Placebo LotionDRUG

Placebo Lotion dosed once.

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with a clinical diagnosis of stable Chronic Open Angle Glaucoma and stable Vital signs who are controlled on a stable dose of a single IOP lowering agent and who have demonstrated stable target intraocular pressure for a minimum of 3 months.
  • Male or Female patients aged at least 18 years of age.
  • Females of childbearing potential must use a reliable form of contraception throughout the study period such as celibacy, birth control pills, or condoms.
  • A negative urine pregnancy test result at Screening and Baseline (Day 1) for women of childbearing potential
  • Best-Corrected Visual Acuity of 20/800 or better in both eyes
  • Written informed consent.
  • Ability to follow instructions and likely to complete all study visits based upon patient factors such as cognition, reliability, motivation, and ability to obtain reliable transportation to study site.

You may not qualify if:

  • Uncontrolled glaucoma
  • Glaucoma requiring more than a single agent for IOP control
  • Patients with a corneal thickness greater then 620 micrometers
  • Female patients who are pregnant, nursing, or planning a pregnancy during the study
  • Patient who has any situation or condition, which in the investigator's opinion, may put the patient at a significant risk, may confound the study result or may interfere significantly with the participation in the study
  • Uncontrolled or labile hypertension
  • At the conclusion of the washout period any study participant with an IOP lower than 22 or greater than 35 mmHg.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Eye Surgical and Medical Associates

Visalia, California, 93277, United States

RECRUITING

MeSH Terms

Conditions

Glaucoma

Interventions

Brimonidine Tartrate

Condition Hierarchy (Ancestors)

Ocular HypertensionEye Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Padma Nanduri, MD

    PRINCIPAL INVESTIGATOR

  • Michael Boone, MD

    STUDY DIRECTOR

Central Study Contacts

Michael Boone, MD

CONTACT

(559)627-9393drboone@visaliaeyecare.com

Padma Nanduri, MD

CONTACT

858-450-1010drnanduri@envisioneye.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDIV

Study Record Dates

First Submitted

April 27, 2011

First Posted

May 2, 2011

Study Start

April 1, 2011

Primary Completion

July 1, 2011

Study Completion

July 1, 2011

Last Updated

May 2, 2011

Record last verified: 2011-04

Locations

US(1)