Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
156 participants
INTERVENTIONAL
2015-01-19
2015-10-07
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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%).
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Bimatoprost Ocular Insert Compared to Topical Timolol Solution in Patients With Glaucoma or Ocular Hypertension
NCT01915940
A Study to Evaluate Efficacy and Safety of a Fixed Combination Ocular Insert in Participants With Open-angle Glaucoma or Ocular Hypertension
NCT02742649
An Open-label Extension Study to Evaluate the Safety of the 13 mg Bimatoprost Ocular Insert
NCT02537015
Evaluation of the Bimatoprost Implant System Used in Combination With the SpyGlass Intraocular Lens Compared to Timolol Ophthalmic Solution
NCT06120842
Safety and Efficacy of Bimatoprost Timolol Ophthalmic Solution in Patients With Open Angle Glaucoma or Ocular Hypertension
NCT01068964
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
13 mg Bimatoprost Ocular Insert
Washout + Placebo Ocular Insert in each eye for 4 to 6 weeks, followed by 13 mg Bimatoprost Ocular Insert in each eye (OU) for 12 weeks. Note: participants also self-administered placebo ophthalmic eye drops to each eye twice a day (BID) for the first 6 weeks. After 12 weeks, 13 mg Bimatoprost Ocular Insert in each eye for an additional 12 weeks.
Bimatoprost
Bimatoprost sustained release Ocular Insert
Placebo Ocular Insert
Placebo ocular insert OU.
Placebo Eye Drops
Placebo eye drops BID OU.
2.2 mg Bimatoprost Ocular Insert
Washout + Placebo Ocular Insert in each eye for 4 to 6 weeks, followed by 2.2 mg Bimatoprost Ocular Insert in each eye for 12 weeks. Note: participants also self-administered placebo ophthalmic eye drops in each eye twice a day for the first 6 weeks. After 12 weeks, 13 mg Bimatoprost Ocular Insert in each eye for an additional 12 weeks.
Bimatoprost
Bimatoprost sustained release Ocular Insert
Placebo Ocular Insert
Placebo ocular insert OU.
Placebo Eye Drops
Placebo eye drops BID OU.
Timolol 0.5%
Washout + Placebo Ocular Insert in each eye for 4 to 6 weeks, followed by 0.5% timolol ophthalmic solution in each eye for 6 weeks. Note: participants simultaneously wore placebo ocular inserts for 12 weeks.
After 12 weeks, 13 mg Bimatoprost Ocular Insert in each eye for an additional 12 weeks.
Bimatoprost
Bimatoprost sustained release Ocular Insert
Timolol 0.5%
BID drops OU, 0.5% ophthalmic solution
Placebo Ocular Insert
Placebo ocular insert OU.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Bimatoprost
Bimatoprost sustained release Ocular Insert
Timolol 0.5%
BID drops OU, 0.5% ophthalmic solution
Placebo Ocular Insert
Placebo ocular insert OU.
Placebo Eye Drops
Placebo eye drops BID OU.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
("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.
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
ForSight Vision5, Inc.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Michelle Chen, PhD
Role: STUDY_DIRECTOR
Allergan
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Vold Vision
Fayetteville, Arkansas, United States
Sall Medical Research Center
Artesia, California, United States
Eye Research Foundation
Newport Beach, California, United States
Clayton Eye Center
Morrow, Georgia, United States
Mundorf Eye Center
Charlotte, North Carolina, United States
Cornerstone Health Care
High Point, North Carolina, United States
Apex Eye
Madeira, Ohio, United States
University of Eye Specialists
Maryville, Tennessee, United States
Total Eye Care
Memphis, Tennessee, United States
R&R Eye Research, LLC
San Antonio, Texas, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
FSV5-004
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.