Nebivolol 0.5, 1.0, or Timolol 0.5 Suspension Compared to Timolol 0.5 Solution to Treat Glaucoma/Ocular Hypertension
Condition: Open-Angle Glaucoma; Ocular Hypertension
MeSH terms: Glaucoma; Glaucoma, Open-Angle; Ocular Hypertension; Hypertension
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the safety (in the eye and throughout the body) and
      effectiveness of nebivolol (0.5 and 1 percent) and timolol (0.5 percent) eye drop
      suspensions. These eye drops will be compared to timolol 0.5 percent eye drop solution in
      participants with open angle glaucoma (the most common type of glaucoma) or high eye pressure
      (ocular hypertension).
    

Detailed description: 
      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.
    

Intervention name(s): Nebivolol Ophthalmic Suspension 1 Percent; Nebivolol Ophthalmic Suspension 0.5 Percent; Timolol Ophthalmic Suspension 0.5 Percent; Timolol Ophthalmic Solution 0.5 Percent
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 1 drop instilled into each eye twice daily; 1 drop instilled into each eye twice daily; 1 drop instilled into each eye twice daily; 1 drop instilled into each eye twice daily
Intervention MeSH terms: Timolol; Nebivolol; Ophthalmic Solutions
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Eligible participants will be randomized in a 1:1:1:1 ratio to 4 treatment arms: nebivolol 0.5% ophthalmic suspension; nebivolol 1.0% ophthalmic suspension; timolol 0.5% ophthalmic suspension; and timolol 0.5% ophthalmic solution.
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment