A Study to Evaluate Efficacy and Safety of a Fixed Combination Ocular Insert in Subjects With Open-angle Glaucoma or Ocular Hypertension
This trial is active, not recruiting.
|Conditions||open-angle glaucoma, ocular hypertension|
|Treatments||fixed combination, bimatoprost, timolol|
|Phase||phase 1/phase 2|
|Sponsor||ForSight Vision5, Inc.|
|Start date||March 2016|
|End date||December 2016|
|Trial size||66 participants|
|Trial identifier||NCT02742649, FSV5-FC-001|
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.
|Endpoint classification||safety/efficacy study|
|Intervention model||crossover assignment|
|Masking||double blind (subject, caregiver, investigator)|
Reduction in Intraocular Pressure (IOP)
time frame: 10 weeks
Safety of the Ocular Insert by regular ocular exams
time frame: 10 weeks
Male or female participants at least 18 years old.
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
|Official title||A Phase 1B, Multicenter, Randomized, Double-masked, Controlled Study to Evaluate the Efficacy and Safety of a Fixed Combination Bimatoprost/Timolol Ocular Insert Compared to Its Individual Components With Crossover to Timolol 0.5% in Subjects With Open-angle Glaucoma (OAG) or Ocular Hypertension (OHT)|
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