Continuous Intraocular Pressure (IOP) Measurement and Abi... | NCT01491867

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

NCT01491867

Sponsor

Semmelweis University

Status

Completed

Last Update Posted

Mar 22, 2013Estimated

Enrollment

9Actual

Phase

Not Applicable

Conditions

Glaucoma
Ocular Hypertension

Interventions

travoprost 0.003%

Countries

Hungary

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2011

Primary Completion Date

Oct 2012Actual

Completion Date

Oct 2012Actual

First Submitted Date

Dec 12, 2011

First Submission Date that Met QC Criteria

Dec 13, 2011

First Posted Date

Dec 14, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 20, 2013

Last Update Posted Date

Mar 22, 2013Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

9Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Travoprost arm	Experimental	All individuals receive travoprost 0.003% 1/day in both eyes after 6 weeks wash-out for 3 months	Drug: travoprost 0.003%

Interventions

Name	Type	Description	Arm Group Labels	Other Names
travoprost 0.003%	Drug	Instillation of travoprost 0.003% 1/die in both eyes for 3 months	Travoprost arm

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Gabor Hollo, MD	Semmelweis University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Departement of Ophthalmology		Budapest	Pest County	1083	Hungary
Semmelweis University

Condition Browse Module

MeSH Terms

ID	Term
D005901	Glaucoma
D009798	Ocular Hypertension

Ancestor Terms

ID	Term
D005128	Eye Diseases

Browse Leaves

Not provided

Browse Branches

Not provided