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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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
Hypertension
Ocular Hypertension
Cardiovascular Diseases
Eye Diseases
Vascular Diseases
Travoprost
Antihypertensive Agents
Cardiovascular Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014