Download Allergan: Title

Allergan – Title:
A Multi-Center, Investigator Masked, Randomized, Parallel Group Comparison
Study to Assess if the Presence of Benzalkonium Chloride (BAK) in a Topical
Fluoroquinolone Reduces the Likelihood of Susceptibility for Induction of Resistant
Organisms in Healthy Adult Subjects
MA-ZYM-08-001
Objective:
To evaluate for the development of resistant ocular isolates following topical use of
Zymar and Vigamox.
Emmes – Title:
Age-Related Eye Disease Study 2 (AREDS2: A Multi-Center, Randomized Trial of
Lutein, Zeanthin, and Omega-3 Long-Chain Polyunsaturated Fatty Acids
(Docosahexaenoic Acid (DHA) and Eicosapentaenoic Acid (EPA) in Age-Related
Macular Degeneration
Objective:
The purpose of this study is to help the doctors learn if certain vitamins or minerals, and
/or dietary supplements, can help to stop or slow down AMD. The study will also look at
if stopping or decreasing certain vitamins or minerals helped slow down AMD.
National Eye Institute – Title:
Infant Aphakia Treatment Study (IATS)
Objectives:
To determine whether infants with a unilateral congenital cataract are more likely to
develop better vision following cataract surgery, have postoperative complications, and
experience less stress if they 1) undergo the primary implantation of a lens or if 2) they
are treated primarily with a contact lens.
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Title:
Antioxidant Systems and Age-Related Macular Degeneration
Objective:
The purpose of this study is to find out if there are changes in blood that would make you
at risk for having age related macular degeneration. The study will help us learn if your
blood has signs of oxidative stress (cell damage). The cell damage is a sign of AMD.
Othera Pharmaceuticals, Inc., - Title:
OT-551-C04- A Randomized, Double-masked, Dose-ranging, Multi-center, Phase II
Study Comparing the Safety and Efficacy of OT-551 with the Placebo to Treat
Geographic Atrophy Associated with Age-related Macular Degeneration
Objective:
The purpose of this study is to find out if an investigational drug called OT-551 is safe
and effective in helping people with macular degeneration to slow down any further
progression of AMD. Investigational means the drug is not approved by the Food and
Drug Association (FDA). OT-551 will be given to you as an eye drop in this study.
Title:
Investigation of Cornea-derived Transcript 6 (CDT6) as a Candidate Gene for
Adult-onset Primary Open-angle Glaucoma (POAG)
Objective:
The purpose of this study is to help us learn if we can identify genes that can be linked to
glaucoma. If the doctors can identify a genetic cause of glaucoma it may lead to
improvement in evaluation and treatment options for patients.
Title:
Investigation of Cornea-derived Transcript 6 (CDT6) as a Candidate Gene for
Primary Congenital Glaucoma
Objective:
The purpose of this study is to help us learn if we can identify genes that can be linked to
glaucoma. If the doctors can identify a gentetic cause of glaucoma it may lead to
improvement in evaluation and treatment options for patients.
JAEB Center - Title:
Nasolacrimal Duct Obstruction Study 3 (NLD3)
A Randomized Trial Comparing Immediate Probing in an Office Setting with
Deferred Probing in a Facility Setting for Treatment of Nasolacrimal Duct
Obstruction in Children 6 to < 10 months old
Objective:
The primary objective of this study is to determine the cost-effectiveness of treating
NLDO using immediate office probing compared with deferred probing in a facility
setting. As part of the primary objective, the study will determine the proportion of eyes
experiencing spontaneous resolution among subjects randomized to the deferred probing
group.
JAEB Center -Title:
Amblyopia Treatment Study (ATS14)
A Pilot Study to Evaluate Levodopa as Treatment for Residual Amblyopia in 8 to 17
Year Olds
Objective:
The study is a single treatment pilot study designed to evaluate levodopa as adjuctive
treatment to patching for residual amblyopia (20/50 or worse) in older children and
teenagers ages 8 to 17 years old. Subjects will be treated with 2 hours of daily patching
plus oral administration of a combination of levodopa and carbidopa for 7 weeks.
Title:
Wavefront Guided Refraction and Prescription of Spectacle Lenses
Objective:
The purpose of this study is to determine if patients who have had LASIK or penetrating
Keratoplasty will have better vision with iZon spectacle lenses instead of traditional
spectacle lenses.
Title:
PIRATE: Preoperative Intravitreal Ranibizumab as Adjunctive Treatment for
Diabetic Retinopathy
Objective: The purpose of the study is to help us learn if the study drug (Lucentis) is safe
and works well when injected into the vitreous before surgery.
The study drug is investigational in this study, which means it is not FDA approved for
this use. We want to find out if it will help decrease the swelling in the back of the eye
Title:
Project PAVE: Providing Access to the Visual Environment
Objective: The purpose of this study is to help children and teenagers with low vision
find out if optical devices (magnifiers, small telescopes, or other lenses) can help them to
see books, the chalkboard, and other objects.
Allergan - Title:
PROOF
A Multi-Center, Prospective, Observational Study of the Progression Of Ocular
Findings in Patients with Dry Eye Disease (MA-RES-08-001)
Objective: The purpose of this study is to develop a better understanding of the natural
history of dry eye.
Title:
Illuminated Low Vision Glasses Trial (ILVG)
Objective: The purpose of this study is to determine if patients who have vision
impairment can read smaller letters using glasses with lights built into the frame. This
study is being done to find out how well the glasses work before being sold to the public.
Allergan – Title:
AKC
A Multicenter, Randomized, Double-Masked, Parallel-Group Study Evaluating the
Efficacy and Safety of Cyclosporine Ophthalmic Solution 0.010% Compared with
its Vehicle Administered QID for 3 Months Followed by a 9 Month Open-Label
Phase in Patients with Atopic Keratoconjunctivitis
Objective: The purpose of this study is to help us learn if using a certain eye drop will
help with the treatment of AKC.
Allergan – Title:
BEG
A One Year, Multicenter, Double-Masked, Randomized, Parallel-Group Study
Assessing the Safety and Efficacy of Once Daily Application of Bimatoprost 0.03%
Solution Compared to Vehicle to Treat Hypotrichosis of the Eyelashes from Varied
Etiologies
Objective: The purpose of this study is to learn about the long-term safety and
effectiveness of the study drug, bimatoprost 0.03% solution, in the treatment of
hypotrichosis (decrease of eyelash growth) of the eyelashes due to natural causes or
related to recent chemotherapy treatment.
Diabetic Clinical Research Center Network – Title:
DRCR protocol L
Evaluation of the Reproducibility of Electronic-ETDRS Measurements in Eyes with
Diabetic Macular Edema
Objective: The purpose of this study is to check the accuracy of a vision testing method
in patients with diabetic macular edema.
Intramural Studies
Department: Multiple Sclerosis Clinic
Novartis Study - Title:
Fingolimud (FTY720)
A 24-month double-blind, randomized, multicenter, placebo-controlled, parallelgroup study comparing the efficacy and safety of 0.5mg and 1.25mg administered
orally once daily versus placebo in patients with relapsing-remitting multiple
sclerosis
Objective:
To compare fingolimod 1.25mg and 0.5mg with placebo to demonstrate that at lest
1.25mg is superior to placebo in terms of annualized relapse rate for patients with RRMS
treated for up to 24 months.
Department: Gastroenterology, Hepatology and Nutrition
Title: ELEVATE
Randomized, Double-Blind, Placebo-Controlled, Multi-Centre Study to Evaluate the
Safety and Efficacy of Eltrombopag to Reduce the Need for Platelet Transfusion in
Thrombocytopenic Subjects with Chronic Liver Disease Undergoing Elective
Invasive Procedures.
ELEVATE: ELtrombopag EValuated for its Ability to overcome
Thrombocytopenia and Enable procedures
Objective:
To demonstrate the ability of eltrombopag, compared to placebo to reduce the proportion
of subjects with chronic liver disease and thrombocytopenia who receive platelet
transfusions administered prior to, during and up to seven days following elective
invasive procedures.
Department: Gastroenterology, Hepatology and Nutrition
Title: ENABLE 1
Randomized, placebo-controlled, multi-centre study to assess the efficacy and safety
of eltrombopag in thrombocytopenic subjects with hepatitis C viris (HCV) infection
who are otherwise eligible to initiate antiviral thereapy (peginterferon alfa-2a plus
ribavirin)
ENABLE 1: Eltrombopag to INitiate and Maintain Interferon Antiviral Treatment
to Benefit Subjects with Hepatitis C related Liver DiseaseE
Department: Gastroenterology, Hepatology and Nutrition
Title: ENABLE 2
Randomized, placebo-controlled, multi-centre study to assess the efficacy and safety
of eltrombopag in thrombocytopenic subjects with hepatitis C viris (HCV) infection
who are otherwise eligible to initiate antiviral thereapy (peginterferon alfa-2b plus
ribavirin)
ENABLE 2: Eltrombopag to INitiate and Maintain Interferon Antiviral Treatment
to Benefit Subjects with Hepatitis C related Liver DiseaseE
Title:
GI 0701
A Phase II, Open Label, Multiple Center Study of huC242-DM4 Given as an
Intravenous Infusion Once Every Three Weeks to Patients with Metastatic Gastric
or Gastroesophageal Junction Carcinomas
Objective:
To assess the objective response rate of huC242-DM4 given as a single intravenous
infusion at 126mg/m2 once every three weeks to patients who have metastatic gastric and
gastroesophageal junction cancer and have low plasma CanAg levels (<1000 U/m1). An
exploratory assessment of response rate in patients with high CanAg levels (> 1000U/ml)
treated with huC242-DM4 given as a single intravenous infusion at 168mg/m2 once
every three weeks will also be performed.
Title:
EDIC
Epidemiology of Diabetes Interventions and Complications