The Effects of the Water Drinking Test on Intraocular Pressure

Not Applicable

Completed

• Conditions: Glaucoma

• Registration Number: NCT01507584
• Lead Sponsor: University of California, San Diego

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.

Study Timeline

• Study Start: 2011-08
• Study First Submitted: 2011-09-01
• Study First Submitted QC: 2012-01-06
• Study First Posted: 2012-01-11
• Primary Completion: 2013-04-30
• Study Completion: 2013-04-30
• Status Verified: 2019-08
• Results First Submitted: 2019-08-19
• Results First Submitted QC: 2019-08-19
• Last Update Submitted: 2019-08-19
• Results First Posted: 2019-09-11
• Last Update Posted: 2019-09-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 23

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Ocular Adverse Events	24-hours	appearance of any device- or non-device-related ocular adverse events

Trial Locations

Locations (1)

Hamilton Glaucoma Center, UCSD; 🇺🇸 La Jolla, California, United States