Acular (Ketorolac Tromethamine Ophthalmic) - Summary

ACULAR SUMMARY

ACULAR^®
(ketorolac tromethamine ophthalmic solution) 0.5%
sterile

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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NEWS HIGHLIGHTS

Media Articles Related to Acular (Ketorolac Ophthalmic)

Cataract Surgery Doesn't Worsen Macular Degeneration: Study
Source: MedicineNet Eye Care Specialty [2009.11.10]
Title: Cataract Surgery Doesn't Worsen Macular Degeneration: Study
Category: Health News
Created: 11/9/2009 4:10:00 PM
Last Editorial Review: 11/10/2009

Cataract Surgery Doesn't Worsen Macular Degeneration: Study (HealthDay)
Source: Y! Health Eyes & Vision News [2009.11.09]
HealthDay - MONDAY, Nov. 9 (HealthDay News) -- Cataract surgery doesn't appear to speed the progression of age-related macular degeneration (AMD), according to a new study that challenges the belief that treating one cause of vision loss worsens the other.

Study Finds Lack Of Diffusible VEGF Growth Factor Can Cause Retinal Defects Similar To Dry Macular Degeneration
Source: Eye Health / Blindness News From Medical News Today [2009.11.03]
Scientists at Schepens Eye Research Institute have found that when the eye is missing a diffusible form of vascular endothelial growth factor (VEGF), i.e. one that when secreted can reach other cells at a distance, the retina shows defects similar to "dry" macular degeneration, also called geographic atrophy (GA).

Ozurdex Implant Approved for Macular Edema
Source: MedicineNet Edema Specialty [2009.06.19]
Title: Ozurdex Implant Approved for Macular Edema
Category: Health News
Created: 6/19/2009 7:00:00 AM
Last Editorial Review: 6/19/2009

Nearly 18 Million Will Have Macular Degeneration by 2050
Source: MedicineNet Macular Degeneration (Age-Related Type) Specialty [2009.04.15]
Title: Nearly 18 Million Will Have Macular Degeneration by 2050
Category: Health News
Created: 4/15/2009 2:00:00 AM
Last Editorial Review: 4/15/2009

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Published Studies Related to Acular (Ketorolac Ophthalmic)

Topical bromfenac 0.09% vs. ketorolac 0.4% for the control of pain, photophobia, and discomfort following PRK. [2009.02]
PURPOSE: To compare the efficacy of two topical nonsteroidal anti-inflammatory drugs with regards to the control of pain, burning, photophobia, foreign body sensation, and epithelial healing rates in patients who underwent photorefractive keratectomy (PRK)... CONCLUSIONS: No significant differences were observed between the use of bromfenac (twice daily) and ketorolac (four times daily) with regard to postoperative PRK discomfort and safety when combined with postoperative measures such as cold BSS and a bandage contact lens.

Acular LS before and during LASIK for the control of pain: a randomized, masked contralateral eye trial. [2009.02]
PURPOSE: To assess the effect of ketorolac tromethamine 0.4% (Acular LS; Allergan Inc) drops in controlling LASIK pain... CONCLUSIONS: Pre- and intraoperative treatment with Acular LS significantly reduces postoperative LASIK pain.

The safety and analgesic efficacy of intranasal ketorolac in patients with postoperative pain. [2008.12]
BACKGROUND: We evaluated the safety and efficacy of multiple doses of intranasal ketorolac tromethamine (ketorolac) for postoperative pain... CONCLUSION: Thirty milligrams of intranasal ketorolac demonstrated significant analgesic efficacy compared to 10 mg of intranasal ketorolac and placebo.

A randomized, masked comparison of topical ketorolac 0.4% plus steroid vs steroid alone in low-risk cataract surgery patients. [2008.10]
PURPOSE: To evaluate whether adding perioperative topical ketorolac tromethamine 0.4% improves cataract surgery outcomes relative to topical steroids alone in patients without known risk factors for cystoid macular edema (CME). DESIGN: Prospective, randomized, investigator-masked, multicenter clinical trial... CONCLUSIONS: This study suggests that adding perioperative ketorolac to postoperative prednisolone significantly reduces the incidences of CME and macular thickening in cataract surgery patients already at low risk for this condition.

Topical ketorolac in vitreoretinal surgery: a prospective, randomized, placebo-controlled, double-masked trial. [2008.09]
OBJECTIVE: To evaluate the effects of topical ketorolac in patients undergoing vitreoretinal surgery... CONCLUSIONS: Topical ketorolac was well tolerated and safe, reduced postoperative pain and inflammation, and improved visual recovery in this prospective, double-masked trial. APPLICATION TO CLINICAL PRACTICE: Topical ketorolac may benefit patients undergoing vitreoretinal surgery. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00576329.

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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%.

Use of Ketorolac in Management of Post-Operative Pain After Heart Surgery [Completed]
This study evaluates the safety and efficacy of ketorolac for post-operative pain management after heart surgery. Ketorolac appears to provide enhanced pain relief while also decreasing the requirements for morphine during the (immediate) 24-hour post-operative period.

Topical 0.4% Ketorolac and Vitreoretinal Surgery [Completed]
To determine whether use of topical 0. 4% ketorolac has any effect on pupil size during vitreoretinal surgery.

Pilot Study of the Effect of Topical Bromfenac Ophthalmic Solution 0.09%in Patients With Acute Post-Operative Cystoid Macular Edema. [Active, not recruiting]
This research is being done to look at the effects of Bromfenac, also called Xibrom for the treatment of swelling in the retina (the light sensitive tissue in the back of the eye) called "macular edema" that occurs after cataract surgery. Swelling in the retina can lead to blurry vision.

The most commonly used treatment is eyedrops that decrease inflammation and may help stop some of the swelling. We want to see if the drug Bromfenac(Xibrom) can decrease the swelling in the retina after cataract surgery and improve vision in these patients.

Comparison of Acular LS Versus Nevanac for Pain Control in Eyes Undergoing PRK [Completed]
To determine the ability of two topical Nonsteroidal Anti-inflammatory drops (Acular LS & Nevanac) to help control pain following Photorefractive Keratectomy (PRK).

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