Phase
Condition
Williams Syndrome
Circulation Disorders
Vascular Diseases
Treatment
Bimatoprost Ophthalmic Solution, 0.01%
LUMIGAN® (bimatoprost ophthalmic solution) 0.01%
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Subjects willing and able to provide voluntary informed consent and to followprotocol requirements.
Male or females aged ≥18 years.
Subjects with chronic open-angle glaucoma or ocular hypertension in both eyes
Subjects requiring treatment of both eyes and able to discontinue the use of allocular hypotensive medication(s) or switch ocular hypotensive medications andundergo appropriate washout period.
Adequate washout period prior to baseline of any ocular hypotensive medications as (to minimize potential risk to subjects due to intraocular pressure (IOP) elevationsduring the washout period, the Investigator may choose to substitute aparasympathomimetic or carbonic anhydrase inhibitor in place of a sympathomimetic,alpha-agonist, beta-adrenergic blocking agent, or prostaglandin; however, all thesubjects must have discontinued their ocular hypotensive medications for the minimumwashout period .
Baseline (Day 0/hour 0) IOP ≥22 mm Hg and <28 mm Hg in each eye, with differencebetween the IOP in left and right eyes not being more than 5 mm Hg
Subjects' IOP is likely to be controlled with monotherapy as per the Investigator'sdiscretion.
Baseline best corrected visual acuity equivalent to Snellen acuity of 20/100 orbetter in each eye, using a logarithmic visual acuity chart for testing at 10 feet (3 meters).
Women of childbearing potential (defined as women physiologically capable ofbecoming pregnant unless they are using an effective method of contraception duringthe dosing of the study drug) practicing any of the following acceptable methods ofcontraception:
Oral or parenteral (injection, patch, or implant) hormonal contraception whichhas been continuously used for at least 1 month prior to first dose of studymedication.
Intrauterine device (IUD) or intrauterine system (IUS)
Double barrier method of contraception (condom and occlusive cap or condom andspermicidal agent)
Male sterilization (at least 6 months prior to screening, should be the solemale partner for that subject)
Female sterilization (surgical bilateral oophorectomy) or tubal ligation atleast 6 weeks prior to study participation
Total abstinence; partial abstinence is not acceptable
No history of addiction to any recreational drug or drug dependence or alcoholaddiction
Exclusion
Exclusion Criteria:
Female who are pregnant, lactating or planning a pregnancy.
Subjects recently diagnosed with open-angle glaucoma or ocular hypertension and whoare treatment naive.
Contraindication or known hypersensitivity to Bimatoprost, related class of drugs,or any of the excipients of formulation.
Current or history of severe hepatic or renal impairment.
Current or history within 2 months prior to baseline of any other significant oculardisease, e.g., corneal edema, uveitis, ocular infection, or ocular trauma in eithereye (Note: stable myopia, strabismus, and cataracts as per the Investigator'sdiscretion will be allowed provided that the other inclusion/exclusion criteria aremet).
Current corneal abnormalities that would prevent accurate IOP readings with Goldmannapplanation tonometer.
Functionally significant visual field loss in the Investigators' opinion.
Subject with corneal grafts.
Subject has contraindication to pupil dilation.
Use at any time prior to baseline of an intraocular corticosteroid implant.
Use of contact lens within 1 week prior to baseline.
Use within 2 weeks prior to baseline of 1) a topical ophthalmic corticosteroid or 2)a topical corticosteroid.
Use within 1 month prior to baseline of 1) a systemic corticosteroid or 2) high-dosesalicylate therapy defined as 325 mg/day and taken on 3 consecutive days.
Use within 6 months prior to baseline of intravitreal or subtenon injection of anophthalmic corticosteroid.
Underwent within 6 months prior to baseline any other intraocular surgery (e.g.,cataract surgery).
Underwent within 12 months prior to baseline any refractive surgery, filteringsurgery, or laser surgery for IOP reduction (e.g., laser trabeculoplasty).
Amblyopia - only one sighted eye.
Subjects with a history of IOP previously uncontrolled on bimatoprost monotherapy.
Significant ocular surface findings (e.g., hyperemia or irritation, mild or greater)in either eye found on gross macroscopic or slit lamp examination.
Severe retinal disease or other severe ocular pathology, such as glaucomatous damagewith a cup/disk ratio greater than 0.8 (not including physiological cupping in theInvestigators' opinion) or split fixation.
Chronic use of any systemic medication that may affect IOP with less than 3 monthsstable dosing regimen (i.e., sympathomimetic agents, beta-adrenergic blockingagents, alpha-agonists, alpha-adrenergic blocking agents, calcium channel blockers,angiotensin-converting enzyme inhibitors, etc.)
Central Corneal thickness (CCT) <450 microns or >650 microns.
Known history or presence of any uncontrolled systemic disease (e.g., cardiovasculardisease, hypertension, diabetes mellitus, hepatic impairment, etc.)
History of recurrent ocular seasonal allergies within the past 2 years.
Any other medical condition or serious intercurrent illness that, in theInvestigator's opinion, may make it undesirable for the subject to participate inthe study and would limit adherence to the study requirements.
Participation in any clinical study within 30 days before the first dose of thestudy drug.
Subjects with known history of positive serology for Hepatitis B Virus (HBV),Hepatitis C Virus (HCV) or Human Immunodeficiency Virus (HIV) infection.
Subjects with positive urine pregnancy test.
Study Design
Study Description
Connect with a study center
West Coast Eye Institute
Bakersfield, California 93308
United StatesActive - Recruiting
Eye Research Foundation
Newport Beach, California 92663
United StatesActive - Recruiting
Clayton Eye Research
Morrow, Georgia 30260
United StatesActive - Recruiting
Houston Eye Associates
Houston, Texas 77008
United StatesActive - Recruiting
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