NCT01362868

Brief Summary

The purpose of this study is to investigate the investigational device capacity to detect an intraocular pressure increase (IOP)induced by water intake.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2011

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

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

May 1, 2011

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

May 27, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 30, 2011

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2011

Completed
Last Updated

November 9, 2011

Status Verified

November 1, 2011

Enrollment Period

6 months

First QC Date

May 27, 2011

Last Update Submit

November 8, 2011

Conditions

Healthy Subjects

Keywords

GlaucomaTriggerfishWater drinking test

Outcome Measures

Primary Outcomes (1)

  • SENSIMED Triggerfish® signal increase when Goldman IOP increase is ≥ 3 mmHg following WDT

    30-45 min after WDT

Interventions

SENSIMED Triggerfish®DEVICE

Soft contact lens-based device for the continuous monitoring of IOP fluctuations

Eligibility Criteria

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

You may qualify if:

  • Healthy volunteer without previous ocular medical history
  • Maximal weight: 100kg
  • BMI lower or equal to 30 kg/m2
  • Subjects having provided informed consent

You may not qualify if:

  • Silicone allergy
  • Cardiovascular disease
  • Diabetes
  • Narrow or closed iridocorneal angle

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unité de Glaucome, Clinique de Montchoisi

Lausanne, 1006, Switzerland

Location

MeSH Terms

Conditions

Glaucoma

Condition Hierarchy (Ancestors)

Ocular HypertensionEye Diseases

Study Officials

  • André Mermoud, MD

    Clinique de Montchoisi

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

May 27, 2011

First Posted

May 30, 2011

Study Start

May 1, 2011

Primary Completion

November 1, 2011

Study Completion

November 1, 2011

Last Updated

November 9, 2011

Record last verified: 2011-11

Locations

CH(1)