NCT00832832

Brief Summary

This research is being done to determine if closing your eyelids after you take your glaucoma drops makes them more effective in lowering your eye pressure, and to determine if closing your eyelids for 5 minutes is better than closing them for one minute

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2009

Typical duration for not_applicable

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

Study Start

First participant enrolled

January 1, 2009

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

January 29, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 30, 2009

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2011

Completed
Last Updated

September 20, 2012

Status Verified

September 1, 2012

Enrollment Period

2 years

First QC Date

January 29, 2009

Last Update Submit

September 19, 2012

Conditions

Glaucoma

Keywords

GlaucomaEye dropIntraocular pressureEyelid closure

Outcome Measures

Primary Outcomes (1)

  • Amount of intraocular pressure lowering

    24 hours

Secondary Outcomes (1)

  • Amount of intraocular pressure lowering

    1 hour and one week

Study Arms (2)

Eyelid closure

EXPERIMENTAL

Eyelids will be closed after administration of eye drop

Other: Eyelid closure

No eyelid closure

ACTIVE COMPARATOR

Eyelids will not be closed after eye drop instillation

Other: No intervention will be assigned

Interventions

Eyelid closureOTHER

Eyelid will be closed after eye drop instillation

Eyelid closure
No intervention will be assignedOTHER

No intervention will be assigned to this arm

Also known as: No intervention needed in Arm 2
No eyelid closure

Eligibility Criteria

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

You may qualify if:

  • Age over 18 years, use of one of the three topical prostaglandins (latanoprost, travaprost, or bimatoprost), and no other IOP-lowering eye drops for at least one month.

You may not qualify if:

  • Previous laser or incisional surgery for glaucoma, use of punctual plugs, an abnormal slit lamp exam (except for cataract or intraocular lens implant) and incisional eye surgery within the last 6 months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Johns Hopkins - The Wilmer Eye Institute

Baltimore, Maryland, 21009, United States

Location

MeSH Terms

Conditions

Glaucoma

Condition Hierarchy (Ancestors)

Ocular HypertensionEye Diseases

Study Officials

  • Henry D Jampel, MD

    Johns Hopkins University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 29, 2009

First Posted

January 30, 2009

Study Start

January 1, 2009

Primary Completion

January 1, 2011

Study Completion

January 1, 2011

Last Updated

September 20, 2012

Record last verified: 2012-09

Locations

US(1)