Dose-Ranging Study of the Bimatoprost Ocular Insert
Condition: Primary Open-Angle Glaucoma; Ocular Hypertension
MeSH terms: Glaucoma; Glaucoma, Open-Angle; Ocular Hypertension; Hypertension
Intervention: Bimatoprost; Timolol 0.5%; Placebo Ocular Insert; Placebo Eye Drops
Intervention description: Bimatoprost sustained release Ocular Insert; BID drops OU, 0.5% ophthalmic solution; Placebo ocular insert OU.; Placebo eye drops BID OU.
Intervention MeSH terms: Timolol; Bimatoprost; Ophthalmic Solutions
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 156.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The Bimatoprost Ocular Insert is intended to provide sustained delivery of bimatoprost to the
      ocular surface to lower the intraocular pressure (IOP) in patients with Open-Angle Glaucoma
      or Ocular Hypertension.

      This study evaluated the safety and efficacy of two different doses of the Bimatoprost Ocular
      Insert, compared to an active control arm with timolol ophthalmic solution (0.5%).
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Written informed consent

          -  At least 18 years of age

          -  Diagnosis in both eyes of either primary open-angle glaucoma (POAG) or ocular
             hypertension

          -  Best corrected-distance visual acuity score equivalent to 20/80 or better

          -  Stable visual field

          -  Central corneal thickness between 490 - 620 micrometers

        Inclusion Criteria at the Randomization Visit:

        ("T" is defined as time and "hr" is defined as hour[s])

          -  IOP for each eye is ≥ 23 mm Hg at T=0 hr, ≥ 20 mm Hg at T=2 hr and T=8 hr.

          -  Inter-eye IOP difference of ≤ 5.0 mm Hg at T=0 hr, T=2 hr and T=8 hr.

          -  IOP for each eye is ≤ 30 mm Hg at T=0 hr, T=2 hr and T=8 hr.

        Key Exclusion Criteria:

          -  Any known contraindication to prostaglandin analog (latanoprost, travoprost,
             bimatoprost, tafluprost) or timolol

          -  A cardiac or pulmonary condition that in the opinion of the Investigator would
             contraindicate the use of beta-blocker drops

          -  Cup-to-disc ratio of greater than 0.8

          -  Significant risk of angle closure due to pupil dilation, defined as a Shaffer
             classification of less than Grade 2 based on gonioscopy

          -  Ocular, orbital, and/or eyelid surgery of any type within the past six (6) months from
             screening date

          -  Laser surgery for glaucoma / ocular hypertension on one (1) or both eyes within the
             last six (6) months

          -  Past history of any incisional surgery for glaucoma at any time

          -  Past history of corneal refractive surgery

          -  Corneal abnormalities that would interfere with accurate IOP readings with an
             applanation tonometer

          -  Current participation in an investigational drug or device study or participation in
             such a study within 30 days of Screening

          -  Inability to adequately evaluate the retina

          -  Participants who will require contact lens use during the study period.

          -  Participants who currently have punctal occlusion

          -  Pregnant, lactating or of child-bearing potential and not using a medically acceptable
             form of birth control