The Effects of the Water Drinking Test on Intraocular Pressure

NCT ID: NCT01507584

Last Updated: 2019-09-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 23 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-08-31
• Study Completion Date: 2013-04-30

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.

Conditions

Glaucoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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)

Group Type: ACTIVE_COMPARATOR

SENSIMED Triggerfish

Intervention Type: DEVICE

Comparison of fluctuation of Intraocular pressures with different class of drugs

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)

Group Type: ACTIVE_COMPARATOR

SENSIMED Triggerfish

Intervention Type: DEVICE

Comparison of fluctuation of Intraocular pressures with different class of drugs

Interventions

SENSIMED Triggerfish

Comparison of fluctuation of Intraocular pressures with different class of drugs

Intervention Type: DEVICE

Other Intervention Names

bimatoprost (Lumigan); brinzolamide (azopt)

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of California, San Diego

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kaweh Mansouri, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Diego

Locations

Hamilton Glaucoma Center, UCSD

La Jolla, California, United States

Countries

United States

Other Identifiers

110903

Identifier Type: -

Identifier Source: org_study_id