Unmedicated IOP Before and After Treatment Clinical Trial
Official title:
Clinical Study Of The Bionode System In Subjects With Elevated Intraocular Pressure (IOP)
The primary objective of this study is to evaluate the safety and effectiveness of the Bionode IOP lowering system in eyes with elevated IOP. The contact lens being studied is similar to an ordinary contact lens that is worn to correct nearsightedness. But the study contact lens has been designed with a thin gold coil around the outside edge of the lens. This design helps deliver a low amount of energy to the eye, which is expected to help lower the pressure inside of the eye. The study contact lens is activated by a pair of glasses (Bionode spectacles) that you wear to apply the treatment to your eye. The study contact lens is only activated when the study glasses are activated.
Subjects will be randomized in 1:1 ratio into two groups, designated Group A and Group B.
During the study, randomized subjects will be fitted with a pair of study contact lenses,
only one of which is embedded with a gold coil to receive electrical stimulation from the
study spectacles, in the study eye. Subjects will also wear optical spectacles (study
spectacles) that deliver the electrical stimulus the study contact lenses.
Group A will receive electrical stimulation (test group), and Group B will not receive
electrical stimulation (control group). Baseline IOP will be recorded prior to the 2-hours
stimulation, and will be repeated post-therapy, at increments of 5 minutes, 30 minutes, 60
minutes, and 2 hours from the conclusion of stimulation. The total duration of participation
for each subject is up to approximately 5 weeks. The total expected duration of the clinical
trial is approximately 4 months.
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