NCT01028664

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2009

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2009

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

December 7, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 9, 2009

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2010

Completed
Last Updated

December 3, 2010

Status Verified

December 1, 2010

Enrollment Period

10 months

First QC Date

December 7, 2009

Last Update Submit

December 2, 2010

Conditions

GlaucomaOcular Hypertension

Keywords

Glaucoma and ocular hypertension patients

Outcome Measures

Primary Outcomes (1)

  • Detection of IOP reduction 2 hours after Diamox administration

    2 hours

Study Arms (1)

Glaucoma or ocular hypertension patients

EXPERIMENTAL
Device: SENSIMED Triggerfish

Interventions

SENSIMED TriggerfishDEVICE

2-hour continuous IOP monitoring

Glaucoma or ocular hypertension patients

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinique de Montchoisi, Centre du Glaucome

Lausanne, 1006, Switzerland

Location

MeSH Terms

Conditions

GlaucomaOcular Hypertension

Condition Hierarchy (Ancestors)

Eye Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

December 7, 2009

First Posted

December 9, 2009

Study Start

December 1, 2009

Primary Completion

October 1, 2010

Study Completion

October 1, 2010

Last Updated

December 3, 2010

Record last verified: 2010-12

Locations

CH(1)