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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01491867
Recruitment Status : Completed
First Posted : December 14, 2011
Last Update Posted : March 22, 2013
Information provided by (Responsible Party):
Gabor Hollo, Semmelweis University

December 12, 2011
December 14, 2011
March 22, 2013
December 2011
October 2012   (Final data collection date for primary outcome measure)
Continuous intraocular pressure (IOP) measurement [ Time Frame: 3 months ]
24-h intraocular pressure (IOP) decrease induced by travoprost 0.003% 1/day as measured with Goldmann tonometry and Sensimed contact lens sensor
Same as current
Complete list of historical versions of study NCT01491867 on Archive Site
Continuous intraocula pressure (IOP) Measurement [ Time Frame: 3 months ]
Reproducibility of intraocular pressure measurements with the Sensimed contact lens sensor methods
Same as current
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Not Provided
Continuous Intraocular Pressure (IOP) Measurement and Ability to Detect Treatment Effect
Evaluation of Continuous IOP Measurement and the Influence of Drug Induced IOP Decrease on the Measurement
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.
  • 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
Not Applicable
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
  • Glaucoma
  • Ocular Hypertension
Drug: travoprost 0.003%
Instillation of travoprost 0.003% 1/die in both eyes for 3 months
Experimental: Travoprost arm
All individuals receive travoprost 0.003% 1/day in both eyes after 6 weeks wash-out for 3 months
Intervention: Drug: travoprost 0.003%
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
October 2012
October 2012   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
Not Provided
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Gabor Hollo, Semmelweis University
Semmelweis University
Not Provided
Principal Investigator: Gabor Hollo, MD Semmelweis University
Semmelweis University
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP