A Phase I/II multi-site study needed to enroll more than 100 patients across three distinct cohorts on an exceeding complex protocol:
- Multiple pre-dosing IOP measurements required for eligibility.
- Strict inclusion based on best-corrected visual acuity (BCVA), cup-to-disc ratio, central corneal thickness; exclusion for recent ocular surgery any history of laser or instrumental orbital surgery, and
- Patients subjected to major lifestyle and dietary restrictions during study participation: no exercise, use of contact lenses, caffeine, chocolate, alcohol, tobacco, vitamins nor analgesics.
- Limited use of oral calcium channel blockers and beta blockers.
- wice-daily office visits requiring multiple procedures, overnight IOP assessments and
The Sponsor implemented 7 protocols amendments over 13 months.