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Continuous Intraocular Pressure (IOP) Measurement and Ability to Detect Treatment Effect

Primary Purpose

Glaucoma, Ocular Hypertension

Status
Completed
Phase
Not Applicable
Locations
Hungary
Study Type
Interventional
Intervention
travoprost 0.003%
Sponsored by
Semmelweis University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Glaucoma focused on measuring intraocular pressure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

  • Departement of Ophthalmology
  • Semmelweis University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Travoprost arm

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Continuous intraocula pressure (IOP) Measurement
Reproducibility of intraocular pressure measurements with the Sensimed contact lens sensor methods

Full Information

First Posted
December 12, 2011
Last Updated
March 20, 2013
Sponsor
Semmelweis University
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1. Study Identification

Unique Protocol Identification Number
NCT01491867
Brief Title
Continuous Intraocular Pressure (IOP) Measurement and Ability to Detect Treatment Effect
Official Title
Evaluation of Continuous IOP Measurement and the Influence of Drug Induced IOP Decrease on the Measurement
Study Type
Interventional

2. Study Status

Record Verification Date
March 2013
Overall Recruitment Status
Completed
Study Start Date
December 2011 (undefined)
Primary Completion Date
October 2012 (Actual)
Study Completion Date
October 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Semmelweis University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Participants are washed ot from all glaucoma medication for 6 weeks one eye per participant is investigated (study eye) 24-h intraocular pressure (IOP) curve is obtained with Goldmann tonometry and Sensimed contact lens sensor tonometry twice, in 14 days for Sensimed contact lens curves median values (in arbitrary units), for Goldmann applanation tonometry, mean and SD values are used to characterize the curves, for comparisions % changes are used for the corresponding time periods treatment (travoprost 0.005% 1/day) is given to all eyes for 3 months 24-h Goldmann and Sensimed IOP curves are repeated IOP curves are determined in arbitrary units and mmHg, respectively, and compared for reproducibility (untreated phase) and relative (%)change (untreated curve vs. under treatment curve) with both methods, respectively

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma, Ocular Hypertension
Keywords
intraocular pressure

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
9 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Travoprost arm
Arm Type
Experimental
Arm Description
All individuals receive travoprost 0.003% 1/day in both eyes after 6 weeks wash-out for 3 months
Intervention Type
Drug
Intervention Name(s)
travoprost 0.003%
Intervention Description
Instillation of travoprost 0.003% 1/die in both eyes for 3 months
Primary Outcome Measure Information:
Title
Continuous intraocular pressure (IOP) measurement
Description
24-h intraocular pressure (IOP) decrease induced by travoprost 0.003% 1/day as measured with Goldmann tonometry and Sensimed contact lens sensor
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Continuous intraocula pressure (IOP) Measurement
Description
Reproducibility of intraocular pressure measurements with the Sensimed contact lens sensor methods
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: primary open-angle glaucoma (POAG), ocular hypertension(OHT) 18 years or older C/D <= 0.7 no risk for visual field damage IOP > 22 mmHg Exclusion Criteria: Pregnancy and lactation Known intolerance to travoprost, topical anesthetic Previous ocular surgery at any time Previous ocular laser treatment within 1 year
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gabor Hollo, MD
Organizational Affiliation
Semmelweis University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Departement of Ophthalmology
City
Budapest
State/Province
Pest
ZIP/Postal Code
1083
Country
Hungary
Facility Name
Semmelweis University
City
Budapest
ZIP/Postal Code
1083
Country
Hungary

12. IPD Sharing Statement

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Continuous Intraocular Pressure (IOP) Measurement and Ability to Detect Treatment Effect

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