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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

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.

Condition or disease Intervention/treatment Phase
Glaucoma Ocular Hypertension Drug: travoprost 0.003% Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 9 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Evaluation of Continuous IOP Measurement and the Influence of Drug Induced IOP Decrease on the Measurement
Study Start Date : December 2011
Actual Primary Completion Date : October 2012
Actual Study Completion Date : October 2012

Resource links provided by the National Library of Medicine

Drug Information available for: Travoprost

Arm Intervention/treatment
Experimental: Travoprost arm
All individuals receive travoprost 0.003% 1/day in both eyes after 6 weeks wash-out for 3 months
Drug: travoprost 0.003%
Instillation of travoprost 0.003% 1/die in both eyes for 3 months

Primary Outcome Measures :
  1. 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

Secondary Outcome Measures :
  1. Continuous intraocula pressure (IOP) Measurement [ Time Frame: 3 months ]
    Reproducibility of intraocular pressure measurements with the Sensimed contact lens sensor methods

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01491867

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Departement of Ophthalmology
Budapest, Pest, Hungary, 1083
Semmelweis University
Budapest, Hungary, 1083
Sponsors and Collaborators
Semmelweis University
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Principal Investigator: Gabor Hollo, MD Semmelweis University

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Responsible Party: Gabor Hollo, Principle Investigator, Semmelweis University Identifier: NCT01491867     History of Changes
Other Study ID Numbers: 4481/2011
First Posted: December 14, 2011    Key Record Dates
Last Update Posted: March 22, 2013
Last Verified: March 2013

Keywords provided by Gabor Hollo, Semmelweis University:
intraocular pressure

Additional relevant MeSH terms:
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Ocular Hypertension
Eye Diseases
Antihypertensive Agents