The Effects of the Water Drinking Test on Intraocular Pressure
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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 Design
Arms and Interventions
| 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:
|
| 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:
|
Outcome Measures
Primary Outcome Measures
- 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
- Ocular Adverse Events [24-hours]
appearance of any device- or non-device-related ocular adverse events
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Hamilton Glaucoma Center, UCSD | La Jolla | California | United States | 92093 |
Sponsors and Collaborators
- University of California, San Diego
Investigators
- Principal Investigator: Kaweh Mansouri, MD, University of California, San Diego
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 110903
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail | 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. |
| Arm/Group Title | ALL PARTICIPANTS |
|---|---|
| Arm/Group Description | |
| Period Title: Overall Study | |
| STARTED | 0 |
| COMPLETED | 0 |
| NOT COMPLETED | 0 |
Baseline Characteristics
| Arm/Group Title | ALL PARTICIPANTS |
|---|---|
| Arm/Group Description | |
| Overall Participants | 0 |
| Age (years) [] | |
| Sex: Female, Male () [] | |
| Female | |
| Male | |
Outcome Measures
| Title | 24-hour IOP Patterns |
|---|---|
| Description | Assess IOP patterns between day and night time and changes after the WDT. |
| Time Frame | 24-hour |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | ALL PARTICIPANTS |
|---|---|
| Arm/Group Description | |
| Measure Participants | 0 |
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | ALL PARTICIPANTS |
|---|---|
| Arm/Group Description | |
| Measure Participants | 0 |
| Title | Ocular Adverse Events |
|---|---|
| Description | appearance of any device- or non-device-related ocular adverse events |
| Time Frame | 24-hours |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | ALL PARTICIPANTS |
|---|---|
| Arm/Group Description | |
| Measure Participants | 0 |
Adverse Events
| Time Frame | ||
|---|---|---|
| Adverse Event Reporting Description | 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. | |
| Arm/Group Title | ALL PARTICIPANTS | |
| Arm/Group Description | ||
All Cause Mortality |
||
| ALL PARTICIPANTS | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/0 (NaN) | |
Serious Adverse Events |
||
| ALL PARTICIPANTS | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/0 (NaN) | |
Other (Not Including Serious) Adverse Events |
||
| ALL PARTICIPANTS | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/0 (NaN) | |
Limitations/Caveats
More Information
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Eunice Williams-Steppe |
|---|---|
| Organization | ucsdmed |
| Phone | 8588221133 |
| emwilliamssteppe@ucsd.edu |
- 110903