search
Back to results

Use of an Ocular Telemetry Sensor in Diamox Treated Patients

Primary Purpose

Glaucoma, Ocular Hypertension

Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
SENSIMED Triggerfish
Sponsored by
Sensimed AG
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Glaucoma focused on measuring Glaucoma and ocular hypertension patients

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Confirmed diagnosis of glaucoma or ocular hypertension
  • IOP of ≥ 15 mmHg.
  • Patients of either gender.
  • Older than 18 years.
  • Patients who accept signing an informed consent approved by the Ethics Committee.

Exclusion Criteria:

  • Patients not able to understand the nature of the research
  • Patients under tutorship
  • Corneal abnormalities in both eyes
  • Subjects with contraindications for wearing contact lenses
  • History of ocular surgery within the last 3 months
  • Known hypersensitivity to Diamox® or to any of its excipients
  • Pregnancy and lactation
  • Simultaneous participation in other clinical research
  • Patients with evidence of ocular infection or inflammation
  • History of renal or hepatic impairment, hypokalemia and hyponatremia

Sites / Locations

  • Clinique de Montchoisi, Centre du Glaucome

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Glaucoma or ocular hypertension patients

Arm Description

Outcomes

Primary Outcome Measures

Detection of IOP reduction 2 hours after Diamox administration

Secondary Outcome Measures

Full Information

First Posted
December 7, 2009
Last Updated
December 2, 2010
Sponsor
Sensimed AG
Collaborators
Clinique de Montchoisi, Lausanne, Switzerland
search

1. Study Identification

Unique Protocol Identification Number
NCT01028664
Brief Title
Use of an Ocular Telemetry Sensor in Diamox Treated Patients
Official Title
Detection of IOP Fluctuation With SENSIMED Triggerfish in Patients With Glaucoma or Ocular Hypertension Treated With Diamox
Study Type
Interventional

2. Study Status

Record Verification Date
December 2010
Overall Recruitment Status
Completed
Study Start Date
December 2009 (undefined)
Primary Completion Date
October 2010 (Actual)
Study Completion Date
October 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Sensimed AG
Collaborators
Clinique de Montchoisi, Lausanne, Switzerland

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
A soft contact lens integrating a Sensor is placed on subjects with high intraocular pressure (IOP) after administration of an IOP-lowering drug to investigate the device's capacity to detect the induced IOP reduction.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma, Ocular Hypertension
Keywords
Glaucoma and ocular hypertension patients

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Glaucoma or ocular hypertension patients
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
SENSIMED Triggerfish
Intervention Description
2-hour continuous IOP monitoring
Primary Outcome Measure Information:
Title
Detection of IOP reduction 2 hours after Diamox administration
Time Frame
2 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Confirmed diagnosis of glaucoma or ocular hypertension IOP of ≥ 15 mmHg. Patients of either gender. Older than 18 years. Patients who accept signing an informed consent approved by the Ethics Committee. Exclusion Criteria: Patients not able to understand the nature of the research Patients under tutorship Corneal abnormalities in both eyes Subjects with contraindications for wearing contact lenses History of ocular surgery within the last 3 months Known hypersensitivity to Diamox® or to any of its excipients Pregnancy and lactation Simultaneous participation in other clinical research Patients with evidence of ocular infection or inflammation History of renal or hepatic impairment, hypokalemia and hyponatremia
Facility Information:
Facility Name
Clinique de Montchoisi, Centre du Glaucome
City
Lausanne
ZIP/Postal Code
1006
Country
Switzerland

12. IPD Sharing Statement

Learn more about this trial

Use of an Ocular Telemetry Sensor in Diamox Treated Patients

We'll reach out to this number within 24 hrs