Phase 2
N=55
A Study to Evaluate Efficacy and Safety of a Fixed Combination Ocular Insert in Participants With Open-angle Glaucoma or Ocular Hypertension
Open-Angle Glaucoma · Ocular Hypertension
Bottom Line
View on ClinicalTrials.gov: NCT02742649 ↗Enrolled (actual)
55
Serious AEs
6.0%
Results posted
Dec 2018
Primary outcome: Primary: Intraocular Pressure (IOP) on Day 8 — 17.83; 19.15; 19.59; 17.51 mm Hg
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Fixed Combination (Drug); Bimatoprost (Drug); Timolol (Drug); Placebo Segment (Device); Timolol 0.5% (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- ForSight Vision5, Inc.
- Primary completion
- Dec 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Intraocular Pressure (IOP) on Day 8 |
17.83; 19.15; 19.59; 17.51; 18.96; 19.88 | — |
| PRIMARY IOP on Day 16 |
18.29; 18.08; 20.81; 17.95; 18.64; 21.08 | — |
| PRIMARY IOP on Day 28 |
18.03; 18.44; 19.75; 18.54; 19.59; 20.09 | — |
| PRIMARY IOP on Day 49 |
18.55; 18.88; 18.63; 17.77; 19.35; 19.67 | — |
| PRIMARY IOP on Day 70 |
17.60; 17.78; 17.79; 18.09; 18.71; 18.48 | — |
| SECONDARY Number of Participants With Ocular and Non-Ocular Adverse Events |
13; 14; 10; 11; 10; 5 | — |
| SECONDARY IOP During Open Label Period |
22.61; 22.69; 23.24; 21.67; 22.38; 22.99 | — |
Summary
The purpose of this study is to determine if a combination of two drugs (bimatoprost and timolol) delivered to the surface of the eye over 10 weeks is better at lowering intraocular pressure (IOP) than either of the drugs delivered alone.
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:
- IOP for each eye is ≥ 23 mmHg at T=0hr, ≥ 20 mmHg at T=4hr and T=8hr.
- Inter-eye IOP difference of ≤ 5.0 mmHg at T=0hr, T=4hr and T=8hr.
- IOP for each eye is ≤ 30 mmHg at T=0hr, T=4hr and T=8hr.
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 a topical beta-blocker
- Use of any agents known to have a substantial effect on IOP during planned study period (e.g. beta-blockers)
- 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 7 days of Screening
- Inability to adequately evaluate the retina
- Subjects who will require contact lens use during the study period.
- Subjects who currently have punctal occlusion
- Pregnant, lactating or of child-bearing potential and not using a medically acceptable form of birth control
Data sourced from ClinicalTrials.gov (NCT02742649). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.