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

Study Overview
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Brief Summary
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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
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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

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

Conditions
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Glaucoma, Ocular Hypertension

Intervention / Treatment
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* Drug: travoprost 0.003%


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Travoprost arm<br>All individuals receive travoprost 0.003% 1/day in both eyes after 6 weeks wash-out for 3 months | Drug: travoprost 0.003%<br>* Instillation of travoprost 0.003% 1/die in both eyes for 3 months<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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intraocular pressure