Water Drinking Test During Intraocular Pressure Fluctuation (IOP) Monitoring

Healthy Subjects Clinical Trial

Official title:

Water Drinking Test (WDT) During Continuous Recording of Intraocular Pressure Fluctuation

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01362868
• Other study ID #: 1012
• Status: Terminated
• Phase: N/A
• First received: May 27, 2011
• Last updated: November 8, 2011
• Start date: May 2011
• Est. completion date: November 2011

Study information

• Verified date: November 2011
• Source: Sensimed AG
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Swiss Agency for Therapeutic Products
• Study type: Interventional

Clinical Trial Summary

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

Description:

32 subjects will be enrolled in the investigation. Eligible subjects will receive one session of 4-6-hour continuous IOP monitoring with SENSIMED Triggerfish® following water drinking test (WDT). SENSIMED Triggerfish® will be installed randomly on right or left eyes and the IOP recording will be initiated as soon as the adaptation of the device on the subject's eye is satisfying. Sensor fitting in the eye will then be evaluated every 60 minutes, until no more spontaneous Sensor movement and rotation are observed. Then IOP will be measured on the contra lateral eye using Goldmann tonometer and the subjects will be asked to drink 1 liter of water within 5 minutes.

After the water drinking, IOP will be measured on the contra lateral eye 10 minutes after the beginning of the test then every 5 minutes until returned to normal. The IOP will be measured again every 20 minutes until 2 hours after the water drinking.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 32
• Est. completion date: November 2011
• Est. primary completion date: November 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Healthy volunteer without previous ocular medical history

• 18 years or more at inclusion

• Maximal weight: 100kg

• BMI lower or equal to 30 kg/m2

• Subjects having provided informed consent

Exclusion Criteria:

• Silicone allergy

• Cardiovascular disease

• Diabetes

• Narrow or closed iridocorneal angle

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Healthy Subjects

Intervention

Device:
• SENSIMED Triggerfish®
Soft contact lens-based device for the continuous monitoring of IOP fluctuations

Locations

Country	Name	City	State
Switzerland	Unité de Glaucome, Clinique de Montchoisi	Lausanne

Sponsors (1)

Lead Sponsor	Collaborator
Sensimed AG

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	SENSIMED Triggerfish® signal increase when Goldman IOP increase is = 3 mmHg following WDT		30-45 min after WDT	No