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

NCT ID: NCT01491867

Last Updated: 2013-03-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 9 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-12-31
• Study Completion Date: 2012-10-31

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

Conditions

Glaucoma; Ocular Hypertension

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Travoprost arm

All individuals receive travoprost 0.003% 1/day in both eyes after 6 weeks wash-out for 3 months

Group Type: EXPERIMENTAL

travoprost 0.003%

Intervention Type: DRUG

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

Interventions

travoprost 0.003%

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

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Semmelweis University

OTHER

Sponsor Role: lead

Responsible Party

Gabor Hollo

Principle Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Gabor Hollo, MD

Role: PRINCIPAL_INVESTIGATOR

Semmelweis University

Locations

Departement of Ophthalmology

Budapest, Pest County, Hungary

Semmelweis University

Budapest, , Hungary

Countries

Hungary

Other Identifiers

4481/2011

Identifier Type: -

Identifier Source: org_study_id