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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01491867

Enrollment

Registered

2011-12-14

Start date

2011-12-31

Completion date

2012-10-31

Last updated

2013-03-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Glaucoma, Ocular Hypertension

Keywords

intraocular pressure

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.

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

Interventions

DRUGtravoprost 0.003%

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Continuous intraocular pressure (IOP) measurement	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

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

Countries

Hungary

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026