The Effects of the Water Drinking Test on Intraocular Pressure

The Effects of the Water Drinking Test on Intraocular Pressure of Glaucoma Patients Undergoing 24 Hour Continuous Monitoring With the SENSIMED Triggerfish

This clinical trial is designed to investigate the efficacy profile of the SENSIMED Triggerfish® during 24-hour IOP monitoring in patients with glaucoma or ocular hypertension, done three times at monthly intervals under different therapeutic regimen. This trial will also evaluate the efficacy of SENSIMED Triggerfish® to detect changes in intraocular pressure (IOP) after the water drinking test (WDT) will be investigated.

Study Overview

• Status: Completed
• Conditions: Glaucoma
• Intervention / Treatment: Device: SENSIMED Triggerfish

Detailed Description

The investigation will recruit male and female patients 18-80 years old and diagnosed with glaucoma or ocular hypertension requiring hypotensive ocular treatment. Up to 100 subjects will be enrolled in the study to ensure a minimum of 80 completing three IOP fluctuation monitoring sessions. Patients will be considered enrolled in the study upon signature of informed consent. A screening visit and three 26-hour IOP fluctuation monitoring sessions are planned for each patient. IOP monitoring sessions will be carried out in ambulatory mode at 4 week intervals (plus/minus 7 days). All subjects will be monitored during the same period of the day (± 1hr). The expected duration of participation for each patient is of 3.5 days over three to four months. Patients will be recruited over a 16-month period. The total expected study duration is 16 months.

• Study Type: Interventional
• Enrollment (Actual): 23
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • La Jolla, California, United States, 92093
      • Hamilton Glaucoma Center, UCSD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Subject is able to comply with the study procedures
• 18-80 years old
• Subjects diagnosed with glaucoma, based on presence of repeatable visual field loss and/or glaucomatous optic neuropathy based on masked review of optic disc stereophotographs and under ocular hypotensive treatment, or diagnosed with ocular hypertension, with an IOP of > 22 mmHg at the screening visit and under ocular hypotensive treatment.
• Subject has consented to be in the trial
• Visual acuity of 20/80 or better
• Ability to understand the character and individual consequences of the study
• For women of childbearing potential, adequate contraception
• Stable anti-hypertensive treatment regimen 4 weeks prior to the screening visit and throughout the study.

Exclusion criteria

• Subjects with chronic kidney failure and chronic hear disease
• Subjects with contraindications for wearing contact lenses
• Severe dry eye syndrome
• Keratoconus or other corneal abnormality
• Conjunctival or intraocular inflammation
• Eye surgery prior to and throughout the study, except prior uncomplicated cataract surgery and laser a minimum of 3 months prior to the screening visit.
• Full frame metal glasses during SENSIMED Triggerfish® monitoring
• Known hypersensitivity to silicone, plaster or ocular anesthesia (proparacaine)
• Pregnancy and lactation
• Simultaneous participation in other clinical studies
• No patient will be allowed to participate in this trial more than once

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Prostaglandin Analogue; WDT protocol Visit 1 - (WDT after washout) 20 Visit 2 - (WDT with treatment) 20 Visit 3 - (WDT with PGA or BB add-on) 20 (PGA + BB)	Device: SENSIMED Triggerfish; Comparison of fluctuation of Intraocular pressures with different class of drugs; Other Names: bimatoprost (Lumigan); brinzolamide (azopt)
Active Comparator: Carbonic Anhydrase Inhibitor; WDT protocol Visit 1 - (WDT after washout) 20 Visit 2 - (WDT with treatment) 20 Visit 3 - (WDT with PGA or BB add-on) 20 (CAI+ BB)	Device: SENSIMED Triggerfish; Comparison of fluctuation of Intraocular pressures with different class of drugs; Other Names: bimatoprost (Lumigan); brinzolamide (azopt)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
24-hour IOP Patterns	Assess IOP patterns between day and night time and changes after the WDT.	24-hour
Intraocular Pressure	IOP monitoring sessions will be carried out in ambulatory mode at 4 week intervals (plus/minus 7 days)	24-hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ocular Adverse Events	appearance of any device- or non-device-related ocular adverse events	24-hours

Collaborators and Investigators

• Sponsor: University of California, San Diego
• Investigators: Principal Investigator: Kaweh Mansouri, MD, University of California, San Diego

Study record dates

Study Major Dates

• Study Start: August 1, 2011
• Primary Completion (Actual): April 30, 2013
• Study Completion (Actual): April 30, 2013

Study Registration Dates

• First Submitted: September 1, 2011
• First Submitted That Met QC Criteria: January 6, 2012
• First Posted (Estimate): January 11, 2012

Study Record Updates

• Last Update Posted (Actual): September 11, 2019
• Last Update Submitted That Met QC Criteria: August 19, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Ocular Hypertension; Glaucoma; Molecular Mechanisms of Pharmacological Action; Antihypertensive Agents; Enzyme Inhibitors; Carbonic Anhydrase Inhibitors; Brinzolamide; Bimatoprost
• Other Study ID Numbers: 110903