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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
History of Changes
  Purpose

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 Intervention
Glaucoma
Ocular Hypertension
 Drug: travoprost 0.003%

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Evaluation of Continuous IOP Measurement and the Influence of Drug Induced IOP Decrease on the Measurement

Resource links provided by NLM:

Drug Information available for: Travoprost
U.S. FDA Resources

Further study details as provided by Semmelweis University:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Enrollment: 9
Study Start Date: December 2011
Study Completion Date: October 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01491867

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

No publications provided

Responsible Party: Gabor Hollo, Principle Investigator, Semmelweis University
ClinicalTrials.gov Identifier: NCT01491867     History of Changes
Other Study ID Numbers: 4481/2011
Study First Received: December 12, 2011
Last Updated: March 20, 2013
Health Authority: Hungary:Budapest Regional Governmental Office

Keywords provided by Semmelweis University:
intraocular pressure

Additional relevant MeSH terms:
Glaucoma
Hypertension
Ocular Hypertension
Eye Diseases
Vascular Diseases
Cardiovascular Diseases
 Travoprost
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 22, 2013