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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Gabor Hollo, Semmelweis University
ClinicalTrials.gov Identifier:
NCT01491867
First received: December 12, 2011
Last updated: March 20, 2013
Last verified: March 2013

December 12, 2011
March 20, 2013
December 2011
October 2012   (final data collection date for primary outcome measure)
Continuous intraocular pressure (IOP) measurement [ Time Frame: 3 months ] [ Designated as safety issue: No ]
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 ClinicalTrials.gov Archive Site
Continuous intraocula pressure (IOP) Measurement [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Reproducibility of intraocular pressure measurements with the Sensimed contact lens sensor methods
Same as current
Not Provided
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
Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: 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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
9
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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Hungary
 
NCT01491867
4481/2011
No
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