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Acular (Ketorolac Tromethamine Ophthalmic) - Summary



ACULAR® (ketorolac tromethamine ophthalmic solution) is a member of the pyrrolo-pyrrole group of nonsteroidal anti-inflammatory drugs (NSAIDs) for ophthalmic use. Its chemical name is (±)-5-Benzoyl-2,3-dihydro-1H-pyrrolizine-1-carboxylic acid, compound with 2-amino-2-(hydroxymethyl)-1,3-propanediol (1:1)

ACULAR® ophthalmic solution is indicated for the temporary relief of ocular itching due to seasonal allergic conjunctivitis. ACULAR® ophthalmic solution is also indicated for the treatment of postoperative inflammation in patients who have undergone cataract extraction.

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Media Articles Related to Acular (Ketorolac Ophthalmic)

Response to Anti-VEGF in Macular Edema Evident at 3 Months
Source: Medscape Ophthalmology Headlines [2015.11.25]
Response to anti-VEGF injections at 3 months is predictive of response at 1 and 3 years, so nonresponders can be switched to a drug with a different mechanism of action early on, researchers report.
Medscape Medical News

Macular Degeneration
Source: MedicineNet Eyeglasses, Sunglasses, and Magnifiers Specialty [2015.05.07]
Title: Macular Degeneration
Category: Diseases and Conditions
Created: 7/23/1999 12:00:00 AM
Last Editorial Review: 5/7/2015 12:00:00 AM

Jetrea Gets FDA Nod for Macular Adhesion
Source: MedPage Today Product Alert [2012.10.19]
WASHINGTON -- The FDA has approved ocriplasmin (Jetrea) as the first nonsurgical treatment for symptomatic vitreomacular adhesion.

'Miniature Telescope' for Eye Approved for Macular Degeneration
Source: MedicineNet Macular Degeneration (Age-Related Type) Specialty [2010.07.07]
Title: 'Miniature Telescope' for Eye Approved for Macular Degeneration
Category: Health News
Created: 7/6/2010 2:10:00 PM
Last Editorial Review: 7/7/2010

Ruboxistaurin (RBX) may reduce risk of vision loss in diabetics
Source: The Doctors Lounge - Endocrinology and Diabetes
Phase III trial demonstrates ruboxistaurin (RBX) may reduce the risk of vision loss especially in diabetic macular edema.

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Published Studies Related to Acular (Ketorolac Ophthalmic)

Prophylactic nepafenac and ketorolac versus placebo in preventing postoperative macular edema after uneventful phacoemulsification. [2012]
randomized clinical trial... CONCLUSIONS: One month after uneventful phacoemulsification, there was no

Comparative evaluation of local infiltration of articaine, articaine plus ketorolac, and dexamethasone on anesthetic efficacy of inferior alveolar nerve block with lidocaine in patients with irreversible pulpitis. [2011.04]
INTRODUCTION: The inferior alveolar nerve block (IANB) has a poor success rate in patients with irreversible pulpitis. The purpose of this study was to evaluate the effect of ketorolac and dexamethasone infiltration along with standard IANB on the success rate... CONCLUSIONS: Articaine and ketorolac infiltration can increase the success rate of IANB in patients with irreversible pulpitis. None of the tested techniques gave 100% success rate. Copyright (c) 2011 American Association of Endodontists. Published by Elsevier Inc. All rights reserved.

Ketorolac tromethamine: stereo-specific pharmacokinetics and single-dose use in postoperative infants aged 2-6 months. [2011.03]
OBJECTIVE: We determined the postoperative pharmacokinetics (PK), safety, and analgesic effects of ketorolac in 14 infants (aged <6 months) receiving a single intravenous (IV) administration of racemic ketorolac or placebo. BACKGROUND: Information on the PK of ketorolac in infants is limited. Unblinded studies suggest ketorolac may be useful in infants... CONCLUSION: Stereo-isomer-specific clearance of ketorolac in infants (aged 2-6 months) shows rapid elimination of the analgesic S (-) isomer as reported in infants aged 6-18 months. No adverse effects were seen after a single IV ketorolac dose. (c) 2010 Blackwell Publishing Ltd.

Twice-daily, preservative-free ketorolac 0.45% for treatment of inflammation and pain after cataract surgery. [2011.03]
PURPOSE: To evaluate the efficacy and safety of twice-daily, preservative-free ketorolac 0.45% (Acuvail; Allergan, Inc, Irvine, California, USA) administration for treatment of inflammation and pain after cataract surgery. DESIGN: Prospective, randomized trial... CONCLUSIONS: Twice-daily ketorolac 0.45% was well tolerated and effectively treated inflammation and pain following cataract surgery. Copyright (c) 2011 Elsevier Inc. All rights reserved.

Ketorolac plus tobramycin/dexamethasone versus tobramycin/dexamethasone after uneventful phacoemulsification surgery: a randomized controlled trial. [2011]
BACKGROUND/AIMS: To evaluate the benefit of adding a nonsteroid agent to an antibiotic/steroid combination after uneventful phacoemulsification, adopting a weekly follow-up, to gain insight into the optimal duration of postoperative treatment and to examine whether risk factors for inflammation exist... CONCLUSION: The addition of ketorolac did not seem to offer any additional benefit in terms of inflammation-related signs. Four weeks appeared as an adequate treatment interval. Special attention should be paid to patients with pseudoexfoliation. Copyright (c) 2010 S. Karger AG, Basel.

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Clinical Trials Related to Acular (Ketorolac Ophthalmic)

Efficient Study of ACULAR in Inhibiting Proliferative Retinopathy in Prematurity [Enrolling by invitation]
The purpose of this study is to test whether ACULAR, a nonsteroidal anti-inflammatory eye drop medication, can prevent the development of retinopathy of prematurity (ROP) and/ or decrease its severity. In this study ACULAR will be compared to a placebo (artificial tear). The hypothesis would be that ACULAR treatment will decrease the incidence of moderate to severe ROP (grade II and above)by 50%.

Ketorolac in Postoperative Infants: Pharmacokinetics and Safety [Completed]
Infants handle ketorolac differently than adults. Study of handling of this pain medication given to infants following surgery. Detailed analysis of how the drug is eliminated from age 2 months to 18 months. Compared morphine use in infants who received the drug to the group getting placebo. Safety testing for kidney and liver function, breathing measured by continuous oximetry, and any bleeding issues.

Pharmacokinetics of Intranasal Ketorolac in Children [Recruiting]
Ketorolac is a non-steroidal anti-inflammatory drug (NSAID) that is typically given to both adults and children by the intravenous (IV) or intramuscular (IM) route for analgesic purposes. Ketorolac can also be given by the intranasal (IN) route using a mucosal atomization device (MAD). We aim to study the pharmacokinetics of ketorolac when administered by the IN route using the MAD.

Intranasal Ketorolac Versus Intravenous Ketorolac for Treatment of Migraine Headaches in Children [Recruiting]
Ketorolac is an evidence-based, first-line acute migraine therapy that is commonly used in the pediatric population; however, it is typically administered by the intravenous (IV) or intramuscular (IM) routes, both of which require a painful and distressing needle stick to administer. The intranasal (IN) route is a painless and effective way of administering analgesics, including ketorolac: IN ketorolac has been shown to be an effective analgesic in adults for painful conditions, including acute migraine headaches. However, IN ketorolac has been understudied in children, and it is not known how effective it is compared to IV ketorolac, which is currently the most common way of administering ketorolac to children. If IN ketorolac is shown to be no less effective than IV ketorolac, IN ketorolac may be a viable and painless alternative to effectively treat acute migraine headaches in children. Therefore, our primary aim is to demonstrate that IN ketorolac is non-inferior to IV ketorolac for reducing pain in children with acute migraine headaches.

A Pilot Study Comparing the Analgesic Efficacy of IV Ibuprofen and IV Ketorolac [Enrolling by invitation]

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Page last updated: 2015-11-25

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