Recruitment

Recruitment Status
Completed
Estimated Enrollment
40

Summary

Conditions
Glaucoma
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Crossover AssignmentMasking: None (Open Label)Primary Purpose: Diagnostic

Participation Requirements

Age
Between 18 years and 80 years
Gender
Both males and females

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...

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.

Tracking Information

NCT #
NCT01507584
Collaborators
Not Provided
Investigators
Principal Investigator: Kaweh Mansouri, MD University of California, San Diego