NCT00966108

Brief Summary

Evaluation of the wearing discomfort (safety and tolerability) involved during IOP monitoring with the SENISMED Triggerfish, a sensor embedded in a telemetric contact lens

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2009

Shorter than P25 for all trials

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

August 1, 2009

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

August 24, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 26, 2009

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2010

Completed
Last Updated

February 4, 2010

Status Verified

February 1, 2010

Enrollment Period

5 months

First QC Date

August 24, 2009

Last Update Submit

February 3, 2010

Conditions

Safety and Tolerability of SENSIMED Triggerfish in Glaucoma Patients

Outcome Measures

Primary Outcomes (1)

  • ocular discomfort on a visual analogue scale

    24 hours

Study Arms (2)

Healthy subjects

Device: SENSIMED Triggerfish

Glaucoma patients

Device: SENSIMED Triggerfish

Interventions

SENSIMED TriggerfishDEVICE

Ocular Telemetry Sensor for IOP monitoring

Glaucoma patientsHealthy subjects

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Healthy subjects and glaucoma patients

You may qualify if:

  • Patient is able to comply with the study procedure
  • Patient is 18-80 years old
  • Healthy subject or glaucoma patient
  • Patient has consented to be in the trial and signed informed consent is available before any study related procedures are carried out
  • Cylinder refraction of no more than +/- 2 diopters in the study eye
  • Visual acuity of 20/80 or better in the study eye
  • Ability of subject to understand the character and individual consequences of the study
  • For women with childbearing potential, adequate contraception

You may not qualify if:

  • Subjects wearing contact lenses within the last two years
  • Subjects with contraindications for wearing contact lenses
  • History of refractive surgery
  • History of intraocular surgery in the last three months
  • Severe dry eye syndrome
  • Keratoconus or other corneal abnormalities
  • Conjunctival or intraocular inflammation
  • Pregnancy and lactation
  • Simultaneous participation in other clinical trials

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universitätsmedizin der Johannes Gutenberg-Universität Mainz

Mainz, Rhineland-Palatinate, 55131, Germany

Location

Study Officials

  • Norbert Pfeiffer, Prof. Dr. med.

    Universitätsmedizin Mainz

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

August 24, 2009

First Posted

August 26, 2009

Study Start

August 1, 2009

Primary Completion

January 1, 2010

Study Completion

January 1, 2010

Last Updated

February 4, 2010

Record last verified: 2010-02

Locations

DE(1)