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

Glaucoma Clinical Trial

Official title:

Evaluation of Continuous IOP Measurement and the Influence of Drug Induced IOP Decrease on the Measurement

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01491867
• Other study ID #: 4481/2011
• Status: Completed
• Phase: N/A
• First received: December 12, 2011
• Last updated: March 20, 2013
• Start date: December 2011
• Est. completion date: October 2012

Study information

• Verified date: March 2013
• Source: Semmelweis University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Hungary:Budapest Regional Governmental Office
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: October 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Glaucoma
• Ocular Hypertension

Intervention

Drug:
• travoprost 0.003%
Instillation of travoprost 0.003% 1/die in both eyes for 3 months

Locations

Country	Name	City	State
Hungary	Departement of Ophthalmology	Budapest	Pest
Hungary	Semmelweis University	Budapest

Sponsors (1)

Lead Sponsor	Collaborator
Semmelweis University

Country where clinical trial is conducted

Hungary, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Continuous intraocula pressure (IOP) Measurement	Reproducibility of intraocular pressure measurements with the Sensimed contact lens sensor methods	3 months	No