The Efficacy and Safety of Bimatoprost SR in Patients With Open-angle Glaucoma or Ocular Hypertensio
- Conditions
- glaucoma and increased pressure inside the eye10018307
- Registration Number
- NL-OMON45083
- Lead Sponsor
- Allergan Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Withdrawn
- Sex
- Not specified
- Target Recruitment
- 5
Key Inclusion Criteria:
• Written informed consent has been obtained
• In the opinion of the investigator, based on prior use or on IOP
rebound (elevation) during the washout period, patient is a responder to
IOP lowering by topical prostamides, prostaglandins, or prostaglandin
analogs
• The iridocorneal angle inferiorly in the study eye must be confirmed as
being qualified by Reading Center AS-OCT assessment
• By the Baseline visit, the final central endothelial cell density in both
eyes must be confirmed as being qualified by Reading Center
assessment
• Diagnosis of either OAG (ie, primary OAG, pseudoexfoliation glaucoma, pigmentary glaucoma) or OHT in each eye, and both eyes require IOPlowering treatment (Note: diagnosis does not have to be the same in both eyes)
• In the investigator's opinion, either eye can be treated adequately with topical ophthalmic beta-blocker (eg. timolol) eye drops as the sole therapy
• In both eyes, at the baseline visit: Hour 0 IOP in the study eye of >= 22 mm Hg and <= 32 mm Hg, and in the fellow eye of <= 32 mm Hg
• In both eyes at Hour 2 IOP in the study eye of >= 19 mm Hg and <= 32 mm Hg, and in the fellow eye of <= 32 mm Hg
History of cataract surgery in the study eye resulting in anterior
chamber intraocular lens implant (IOL), phakic IOL, sulcus IOL, aphakia,
or complications (eg, a posterior capsular tear [with or without vitreous
loss], iris trauma, etc)
• In the investigator's opinion, patient is nonresponsive to topical ophthalmic beta-blockers and/or topical prostamides, prostaglandins, or prostaglandin analogs (eg, LUMIGAN, Xalatan, Travatan)
• Contraindications to beta-blocker therapy
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Response Measures<br /><br>Efficacy: Intraocular pressure (IOP) measured by Goldmann applanation<br /><br>tonometry<br /><br>Safety: Adverse events; ocular parameters as determined through assessment of<br /><br>visual acuity and visual field; evaluation of macroscopic bulbar conjunctival<br /><br>hyperemia and iris color; assessment of endothelial cell density and corneal<br /><br>thickness; IOP measurement, biomicroscopic and ophthalmoscopic examinations<br /><br>(including gonioscopy with Bimatoprost SR implant assessment, optic disc<br /><br>examination and dilated fundus examination); and optical coherence tomography<br /><br>(OCT) of the macula.</p><br>
- Secondary Outcome Measures
Name Time Method <p>NA</p><br>