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The Effects of the Water Drinking Test on Intraocular Pressure

Primary Purpose

Glaucoma

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
SENSIMED Triggerfish
Sponsored by
University of California, San Diego
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Glaucoma

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hamilton Glaucoma Center, UCSD

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Prostaglandin Analogue

Carbonic Anhydrase Inhibitor

Arm Description

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)

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)

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Ocular Adverse Events
appearance of any device- or non-device-related ocular adverse events

Full Information

First Posted
September 1, 2011
Last Updated
August 19, 2019
Sponsor
University of California, San Diego
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1. Study Identification

Unique Protocol Identification Number
NCT01507584
Brief Title
The Effects of the Water Drinking Test on Intraocular Pressure
Official Title
The Effects of the Water Drinking Test on Intraocular Pressure of Glaucoma Patients Undergoing 24 Hour Continuous Monitoring With the SENSIMED Triggerfish
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
August 2011 (undefined)
Primary Completion Date
April 30, 2013 (Actual)
Study Completion Date
April 30, 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Diego

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
23 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Prostaglandin Analogue
Arm Type
Active Comparator
Arm Description
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)
Arm Title
Carbonic Anhydrase Inhibitor
Arm Type
Active Comparator
Arm Description
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)
Intervention Type
Device
Intervention Name(s)
SENSIMED Triggerfish
Other Intervention Name(s)
bimatoprost (Lumigan); brinzolamide (azopt)
Intervention Description
Comparison of fluctuation of Intraocular pressures with different class of drugs
Primary Outcome Measure Information:
Title
24-hour IOP Patterns
Description
Assess IOP patterns between day and night time and changes after the WDT.
Time Frame
24-hour
Title
Intraocular Pressure
Description
IOP monitoring sessions will be carried out in ambulatory mode at 4 week intervals (plus/minus 7 days)
Time Frame
24-hours
Secondary Outcome Measure Information:
Title
Ocular Adverse Events
Description
appearance of any device- or non-device-related ocular adverse events
Time Frame
24-hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kaweh Mansouri, MD
Organizational Affiliation
University of California, San Diego
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hamilton Glaucoma Center, UCSD
City
La Jolla
State/Province
California
ZIP/Postal Code
92093
Country
United States

12. IPD Sharing Statement

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The Effects of the Water Drinking Test on Intraocular Pressure

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