NCT01491867

Brief Summary

Continuous intraocular pressure (IOP) measurement with a contact lens sensor may provide more information on the drug-related IOP change than 24-hour IOP measurement with Goldmann applanation tonometry (GAT.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
9

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2011

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

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

December 1, 2011

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

December 12, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 14, 2011

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2012

Completed
Last Updated

March 22, 2013

Status Verified

March 1, 2013

Enrollment Period

10 months

First QC Date

December 12, 2011

Last Update Submit

March 20, 2013

Conditions

GlaucomaOcular Hypertension

Keywords

intraocular pressure

Outcome Measures

Primary Outcomes (1)

  • Continuous intraocular pressure (IOP) measurement

    24-h intraocular pressure (IOP) decrease induced by travoprost 0.003% 1/day as measured with Goldmann tonometry and Sensimed contact lens sensor

    3 months

Secondary Outcomes (1)

  • Continuous intraocula pressure (IOP) Measurement

    3 months

Study Arms (1)

Travoprost arm

EXPERIMENTAL

All individuals receive travoprost 0.003% 1/day in both eyes after 6 weeks wash-out for 3 months

Drug: travoprost 0.003%

Interventions

travoprost 0.003%DRUG

Instillation of travoprost 0.003% 1/die in both eyes for 3 months

Travoprost arm

Eligibility Criteria

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

You may qualify if:

  • primary open-angle glaucoma (POAG), ocular hypertension(OHT)
  • years or older
  • C/D \<= 0.7
  • no risk for visual field damage
  • IOP \> 22 mmHg

You may not qualify if:

  • Pregnancy and lactation
  • Known intolerance to travoprost, topical anesthetic
  • Previous ocular surgery at any time
  • Previous ocular laser treatment within 1 year

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Departement of Ophthalmology

Budapest, Pest County, 1083, Hungary

Location

Semmelweis University

Budapest, 1083, Hungary

Location

MeSH Terms

Conditions

GlaucomaOcular Hypertension

Condition Hierarchy (Ancestors)

Eye Diseases

Study Officials

  • Gabor Hollo, MD

    Semmelweis University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle Investigator

Study Record Dates

First Submitted

December 12, 2011

First Posted

December 14, 2011

Study Start

December 1, 2011

Primary Completion

October 1, 2012

Study Completion

October 1, 2012

Last Updated

March 22, 2013

Record last verified: 2013-03

Locations

HU(2)