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.

Study Overview

• Status: Completed
• Conditions: Ocular Hypertension; Glaucoma
• Intervention / Treatment: Drug: travoprost 0.003%

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

• Study Type: Interventional
• Enrollment (Actual): 9
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Hungary
  • Budapest, Hungary, 1083
    • Semmelweis University
  • Pest
    • Budapest, Pest, Hungary, 1083
      • Departement of Ophthalmology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Continuous intraocular pressure (IOP) measurement	24-h intraocular pressure (IOP) decrease induced by travoprost 0.003% 1/day as measured with Goldmann tonometry and Sensimed contact lens sensor	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Continuous intraocula pressure (IOP) Measurement	Reproducibility of intraocular pressure measurements with the Sensimed contact lens sensor methods	3 months

Collaborators and Investigators

• Sponsor: Semmelweis University
• Investigators: Principal Investigator: Gabor Hollo, MD, Semmelweis University

Study record dates

Study Major Dates

• Study Start: December 1, 2011
• Primary Completion (ACTUAL): October 1, 2012
• Study Completion (ACTUAL): October 1, 2012

Study Registration Dates

• First Submitted: December 12, 2011
• First Submitted That Met QC Criteria: December 13, 2011
• First Posted (ESTIMATE): December 14, 2011

Study Record Updates

• Last Update Posted (ESTIMATE): March 22, 2013
• Last Update Submitted That Met QC Criteria: March 20, 2013
• Last Verified: March 1, 2013

More Information

Terms related to this study

• Keywords: intraocular pressure
• Additional Relevant MeSH Terms: Eye Diseases; Ocular Hypertension; Antihypertensive Agents; Travoprost
• Other Study ID Numbers: 4481/2011