The Effects of the Water Drinking Test on Intraocular Pressure

NCT01507584 | Completed Results

• 1 other identifier: 110903
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

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.

Conditions

Glaucoma

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Ocular Adverse Events

  24-hours

Study Arms (2)

Prostaglandin Analogue

ACTIVE COMPARATOR

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

Carbonic Anhydrase Inhibitor

ACTIVE COMPARATOR

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

Interventions

SENSIMED Triggerfish DEVICE

Comparison of fluctuation of Intraocular pressures with different class of drugs

Also known as: bimatoprost (Lumigan); brinzolamide (azopt)

Carbonic Anhydrase Inhibitor; Prostaglandin Analogue

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject is able to comply with the study procedures
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, San Diego: lead

Study Sites (1)

Hamilton Glaucoma Center, UCSD

La Jolla, California, 92093, United States

Location

MeSH Terms

Conditions

Glaucoma

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases

Limitations and Caveats

The PI has left the institution and the study data can not be located. Multiple attempts where made to reach the study team, so there are no results to report.

Results Point of Contact

• Title: Eunice Williams-Steppe
• Organization: ucsdmed

emwilliamssteppe@ucsd.edu

8588221133

Study Officials

• Kaweh Mansouri, MD

  University of California, San Diego

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 1, 2011
• First Posted: January 11, 2012
• Study Start: August 1, 2011
• Primary Completion: April 30, 2013
• Study Completion: April 30, 2013
• Last Updated: September 11, 2019
• Results First Posted: September 11, 2019

Record last verified: 2019-08

Locations

US (1)