Finding studies
Finding studies
Take this into the appointment.
Saves the questions and what to expect into your notes, next to the visit they belong to.
Lead
Betaliq, Inc.
With
The study will enroll 240 participants (60 in each treatment arm) who will be treated for 84 days (12 weeks). Participants will have OAG (open angle glaucoma) or OHT (ocular hypertension) in both eyes (OAG in one eye and OHT in the follow eye is acceptable) that requires therapy and elevated IOP (intraocular pressure) adequately controlled on no more than 2 ocular hypertensive medications. Participants with OHT on no ocular hypotensive medications are acceptable. After being informed about the study and potential risks, participants giving written informed consent will undergo an washout period, if required, from previous glaucoma medications (28 days for prostaglandin analogs, rho-associated protein kinase inhibitors, or beta blockers; 14 days for adrenergic agonists; and 5 days for muscarinic agonists or carbonic anhydrase inhibitors). Eligible participants must have unmedicated IOP measurements at Visit 3/Baseline ≥ 22 and ≤ 34 mm Hg at 8:00 AM and ≥ 18 and ≤ 34 mm Hg at 10:00 AM and 4:00 PM (each qualifying eye must fall within the required IOP range at all 3 time points and must be at least 22 mm Hg at each consecutive measurement at the 8:00 AM time point). Both eyes will be treated twice daily. Study visits will comprise Visit 1/Screening/Day -35 to -1, Visit 2/Washout Safety Check/Day -14 ± 3 (performed for participants undergoing 28-day washout periods at the Investigator's discretion), Visit 3/Qualification/Baseline/Day 1, Visit 4/Day 15 ± 3, Visit 5/Day 42 ± 3, and Visit 6/Day 84 ± 3. At Visits 4, 5, and 6, participants will be evaluated at 8:00 AM, at 2 hours after study medication dosing at the clinical site (approximately 10:00 AM), and at 4:00 PM (each ± 30 minutes). All ophthalmic assessments will be performed bilaterally.
Age
18–100
Sex
ALL
Healthy volunteers
Not accepted
